BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)

{0} [LOGO] FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION ## DECISION SUMMARY ASSAY ONLY ### I Background Information: #### A 510(k) Number K252344 #### B Applicant Becton, Dickinson and Company #### C Proprietary and Established Names BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) #### D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | JKA | Class II | 21 CFR 862.1675 Blood Specimen Collection Device | CH - Clinical Chemistry | ### II Submission/Device Overview: #### A Purpose for Submission: Modification of existing device #### B Measurand: Not applicable, blood collection tube #### C Type of Test: Not applicable Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} ### III Intended Use/Indications for Use: #### A Intended Use(s): See Indications for Use below. #### B Indication(s) for Use: BD Vacutainer® Serum Blood Collection Tubes: BD Vacutainer® Serum Blood Collection Tubes are evacuated, sterile, single-use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, containment and transport of human venous blood specimens, and the subsequent separation and storage of serum for in vitro diagnostic testing. BD Vacutainer® Serum Blood Collection Tubes are used for the testing of chemistry analytes. BD Vacutainer® Rapid Serum Tubes (RST): BD Vacutainer® RST Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, containment and transport of human venous blood specimens, and the subsequent separation and storage of serum for in vitro diagnostic testing. BD Vacutainer® RST Blood Collection Tubes are used for testing of chemistry analytes. #### C Special Conditions for Use Statement(s): Rx – For Prescription Use Only BD Vacutainer® Serum Blood Collection Tubes: Warning: BD Vacutainer® Serum Blood Collection Tubes should not be used for Potassium (K) testing due to demonstrated variability based on preanalytical factors. Storage of glass tubes containing blood at or below 0°C may result in tube breakage. Do not use if foreign matter is present or if tube is damaged. Follow your facility's procedures if clots or other visible obstructions are present in the serum sample as this could lead to the inability to test the sample. When serum is required for testing, separation of serum from the clot should take place within 2 hours of collection to prevent potentially erroneous test results. Whenever changing any manufacturer's blood collection tube type, size, handling, processing or storage condition for a particular laboratory assay, the laboratory personnel should review the tube manufacturer's data and their own data to establish/verify the reference range for a specific instrument/reagent system. Based on such information, the laboratory can then decide if changes are appropriate. K253539 - Page 2 of 41 {2} BD Vacutainer® Serum Blood Collection Tubes may contain trace levels of formate and hexane. It has not been determined if the presence of trace levels of these or other compounds will affect test results in chromatography-based assays and the performance of BD Vacutainer® Serum Blood Collection Tubes with chromatographic assays has not been evaluated. In clinical studies, when BD Serum Non-Separator tubes were compared to a Serum Separator tube for Potassium testing, the largest observed bias at the Critical Value (CV) of 2.8 mmol/L was a unit bias of -0.483 mmol/L and the largest observed bias at the Critical Value (CV) of 6.2 mmol/L was a unit bias of 0.735 mmol/L. Potassium results may be affected by preanalytical variables associated with prolonged contact between serum and cellular components. These variables include, but are not limited to, delayed centrifugation, specimen agitation, and delayed testing. Because potassium is sensitive to prolonged cellular contact, such conditions can lead to altered potassium measurements. ### BD Vacutainer® Rapid Serum Tubes (RST): Do not use if foreign matter is present or if tube is damaged. Follow your facility's procedures if clots or other visible obstructions are present in the serum sample as this could lead to the inability to test the sample. Separation of serum from the clot should take place within 2 hours of collection to prevent potentially erroneous test results. Whenever changing any manufacturer's blood collection tube type, size, handling, processing or storage condition for a particular laboratory assay, the laboratory personnel should review the tube manufacturer's data and their own data to establish/verify the reference range for a specific instrument/reagent system. Based on such information, the laboratory can then decide if changes are appropriate. The performance of BD Vacutainer® RST™ Tubes with chromatographic assays has not been evaluated. BD Vacutainer® RST™ Blood Collection Tubes are not recommended for amino acid determinations. Therapeutic drug monitoring (TDM), blood banking, and infectious disease performance have not been established. Clot time has not been established for patients on heparin therapy, direct thrombin inhibitor therapy or with Factor I deficiency. As a result, the use of the BD Vacutainer® RST™ Tube in these patients is not recommended. The flow properties of the barrier material are temperature-related. Centrifuge the tubes between 23°C and 27°C (73-81°F). Tubes should not be re-centrifuged once barrier has formed. K253539 - Page 3 of 41 {3} # D Special Instrument Requirements: Not applicable. # IV Device/System Characteristics: # A Device Description: BD Vacutainer® Serum Blood Collection Tubes are plastic or glass, evacuated, sterile, single-use in vitro diagnostic medical devices. The tube is comprised of either plastic or glass coated with a silicone surfactant. Depending on configuration, the tube utilizes either a conventional rubber stopper or Hemogard cap assembly. The interior walls of BD Vacutainer® Serum plastic tubes are spray coated with a silica clot activator, to promote specimen clotting. The tubes are available in 13x75mm, 13x100mm and 16x100mm configurations with draw volumes ranging from 3.0 to 10 mL. BD Vacutainer® Rapid Serum Tubes (RST) are plastic, evacuated, single-use, in vitro diagnostic medical devices. The tube is comprised of a plastic tube coated with a silicone surfactant and utilizes a Hemogard cap assembly. The interior of the tube wall is coated with thrombin to promote rapid clotting. The tube contains an inert gel barrier polymer at the bottom. During centrifugation, this material moves upward to the serum-clot interface, forming a barrier that separates serum from the clot. The tubes are available in a 13x100mm configuration with draw volume of 5.0 mL. # B Principle of Operation: The BD Vacutainer® Serum Blood Collection Tubes utilize vacuum-assisted blood collection combined with clot formation to collect and process blood samples. The tubes are comprised of a sterile, glass or plastic tube that contains a silica clot activator to promote clot formation. When the tube is connected to a needle inserted into a vein, the internal vacuum creates a pressure difference that automatically draws a specific volume of blood. Once filled, the tubes are gently inverted 5 to 6 times then kept in an upright orientation for at least 60 minutes to allow for clotting. BD Vacutainer® Rapid Serum Tubes use thrombin to reduce the time required to clot the samples. Once filled, the tubes are gently inverted 5 to 6 times then kept in an upright orientation for at least 5 minutes to allow for clotting. Both tube types are designed to undergo centrifugation following clot formation, to separate serum from red blood cells and other cellular components, enabling downstream testing. The BD RST additionally contains an inert gel separator that migrates to the serum-clot interface during centrifugation, forming a mechanical barrier that isolates the serum from the clot. The recommended centrifugation conditions are: Serum tube: 1,300 RCF (relative centrifugal force or g) for 10 minutes RST tube: 1500 RCF for 10 minutes or 2,000 RCF for 5 min or 4,000 RCF for 3 min. K253539 - Page 4 of 41 {4} The tubes are compatible with BD Vacutainer® Serum Blood Collection Needles, Blood Collection Sets, Transfer Devices, Holders, and Adapters. # V Substantial Equivalence Information: # A Predicate Device Name(s): BD Vacutainer® Brand PLUS (Plastic) Serum and SST® Serum Separator Blood Collection Tubes, BD Vacutainer® Rapid Serum Tube Blood Collection Tube with Hemogard™ Closure # B Predicate 510(k) Number(s): K960250, K101502, # C Comparison with Predicate(s): | Device & Predicate Device(s): | K252344 | K960250 | | --- | --- | --- | | Device Trade Name | BD Vacutainer® Serum Blood Collection Tubes | BD Vacutainer® Brand PLUS (Plastic) Serum and SST® Serum Separator Blood Collection Tubes | | General Device Characteristic Similarities | | | | Intended Use | Used by trained healthcare professionals for the collection, containment and transport of human venous blood specimens, and the subsequent separation and storage of serum for in vitro diagnostic testing of chemistry analytes. | Same | | Tube Dimension | 13 x 75 mm, 13 x 100 mm 16 x 100 mm | Same | | Sample Type | Serum | Same | | Additive Type | Silica Clot Activator | Same | | Tube Material | PET (polyethylene terephthalate) plastic or Soda Lime Glass | Same | | Sterilization Method | Gamma Irradiation | Same | K253539 - Page 5 of 41 {5} | **Device & Predicate Device(s):** | K252344 | K960250 | | --- | --- | --- | | **General Device Characteristic Differences** | | | | Tube Draw Volumes | 3.0mL, 4.0mL, 5.0mL, 6.0mL, and 10.0mL | 3.5mL – 10.0mL | | Labeling warning against potassium testing | Yes | No | | **Device & Predicate Device(s):** | K252344 | K101502 | | --- | --- | --- | | Device Trade Name | BD Vacutainer® Rapid Serum Tubes (RST) | BD Vacutainer® Rapid Serum Tube Blood Collection Tube with Hemogard™ Closure | | **General Device Characteristic Similarities** | | | | Intended Use/Indications For Use | Used by trained healthcare professionals for the collection, containment and transport of human venous blood specimens, and the subsequent separation of serum for in vitro diagnostic testing of chemistry analytes. | Same | | Sample Type | Serum | Same | | Additive Type | Thrombin Clot activator | Same | | Separator gel | Polyacrylic gel | Same | | Tube Material | PET (polyethylene terephthalate) plastic | Same | | Sterilization Method | Gamma Irradiation | Same | | Tube Dimension | 13 x 100 mm | Same | | Tube Draw Volumes | 5mL | Same | | **General Device Characteristic Differences** | | | | Shelf Life | 15 months | 12 months | ## VI Standards/Guidance Documents Referenced: ISO 11137-1:2006/(R)2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)]. K253539 - Page 6 of 41 {6} ISO 11137-2:2013/(R)2019 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose. ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control. ISO 11737-2:2019 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process. ANSI AAMI ST67:2019 Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile". ISO 14971: 2019-12 Medical devices-Application of risk management to medical devices ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products. ## VII Performance Characteristics (if/when applicable): ### A Analytical Performance: The following table provides abbreviations for the analytes used in the validation testing of the candidate devices. | Abbreviation | Analyte | Abbreviation | Analyte | | --- | --- | --- | --- | | ALB | Albumin | hsTnI | High Sensitivity Troponin I | | ALKP | Alkaline Phosphatase | IgA | Immunoglobulin A | | ALT | Alanine Aminotransferase | IgG | Immunoglobulin G | | AMY | Amylase | IgM | Immunoglobulin M | | AST | Aspartate Aminotransferase | K | Potassium | | BUN | Blood Urea Nitrogen | LDH | Lactate Dehydrogenase | | C3 | Complement Component 3 | LDL | Low-Density Lipoprotein | | Ca | Calcium | LH | Luteinizing Hormone | | Chol | Cholesterol | Lip | Lipase | | CK | Creatine Kinase | Mg | Magnesium | | CKMB | Creatine Kinase-MB | Na | Sodium | | CL | Chloride | NT-proBNP | N-Terminal Pro B-Type Natriuretic Peptide | | CO_{2} | Carbon Dioxide | Phos | Phosphorus | | CORT | Cortisol | PROG | Progesterone | | Creat | Creatinine | RF | Rheumatoid Factor | | CRP | C-Reactive Protein | TBIL | Total Bilirubin | K253539 - Page 7 of 41 {7} | Abbreviation | Analyte | Abbreviation | Analyte | | --- | --- | --- | --- | | DBIL | Direct Bilirubin | TESTO | Testosterone | | E2 | Estradiol | TnI | Troponin I | | Fe | Iron | TnT | Troponin T | | FERR | Ferritin | Total T3 | Total Triiodothyronine | | FOLATE | Folate | Total T4 | Total Thyroxine | | Free T3 | Free Triiodothyronine | TP | Total Protein | | Free T4 | Free Thyroxine | TPSA | Total Prostate-Specific Antigen | | FSH | Follicle-Stimulating Hormone | TRF | Transferrin | | GGT | Gamma-Glutamyl Transferase | Trig | Triglycerides | | GLUC | Glucose | TSH | Thyroid-Stimulating Hormone | | HAPTO | Haptoglobin | UA | Uric Acid | | HCG | B-Human Chorionic Gonadotropin | Vit B12 | Vitamin B12 | | HDL | High-Density Lipoprotein | Vit D | Vitamin D | # 1. Precision/Reproducibility: A multi-part study was conducted to evaluate repeatability (within tube), lot-to-lot reproducibility and tube-to-tube reproducibility of BD Vacutainer® Serum Plastic Blood Collection Tubes, BD Vacutainer® Serum Glass Blood Collection Tubes and BD Vacutainer® RST Blood Collection Tubes for select routine and specialty chemistry analytes. Testing of select analytes was conducted across the following instruments: Roche cobas® Integra 400 Plus, Beckman Coulter AU480, Roche cobas e411, Beckman Coulter Access 2, Siemens Atellica and Roche cobas 6000. # BD Vacutainer® Serum Plastic Blood Collection Tubes Blood was collected from each subject (n=55) into 6 BD Vacutainer® Serum Plastic Tubes. Specimens were tested with 2 tubes per lot across 3 lots on 2 instrument platforms for the following select routine and special chemistry analytes: ALT, C3, Ca, CL, CORT, GLUC, IgG, LDH, Phos, Free T4, Total T4, TBIL, TESTO, TP, TPSA and Trig. Contrived samples (less than 15%) were also used to cover the clinically relevant range for some analytes as necessary. Total, Between-Lot, Between-Tube, and Within-Tube variability for each instrument platform are presented in the tables below: | Test System | Analyte (Unit) | Mean | Variance Component | SD | SD 95% CI | CV (%) | CV 95% CI | | --- | --- | --- | --- | --- | --- | --- | --- | | Beckman Coulter AU480 | ALT (U/L) | 20.4 | Between Lots | 0.3 | 0.2, 0.3 | 0.9% | 0.8%, 1.1% | | | | | Between Tubes | 0.7 | 0.6, 0.8 | 3.4% | 2.5%, 4.2% | | | | | Within Tubes | 0.5 | 0.4, 0.6 | 3.2% | 2.8%, 3.8% | | | | | Total | 0.9 | 0.7, 1.2 | 4.8% | 3.9%, 6.2% | | | ALT (U/L) | 20.55 | Between Lots | 0.1 | 0.09, 0.12 | 2.2% | 1.9%, 2.6% | | | | | Between Tubes | 0.81 | 0.63, 0.96 | 0.4% | 0%, 2.5% | K253539 - Page 8 of 41 {8} | Test System | Analyte (Unit) | Mean | Variance Component | SD | SD 95% CI | CV (%) | CV 95% CI | | --- | --- | --- | --- | --- | --- | --- | --- | | Roche cobas Integra 400 Plus | | | Within Tubes | 0.58 | 0.51, 0.69 | 4.5% | 3.9%, 5.3% | | | | | Total | 1.01 | 0.81, 1.32 | 5% | 4.1%, 6.6% | | Roche cobas Integra 400 Plus | C3 (mg/dL) | 143.3 | Between Lots | 1.7 | 1.5, 2 | 1.2% | 1%, 1.4% | | | | | Between Tubes | 1.1 | 0, 1.7 | 0.5% | 0%, 0.9% | | | | | Within Tubes | 2.1 | 1.8, 2.5 | 1.5% | 1.3%, 1.7% | | | | | Total | 2.9 | 2.4, 3.8 | 1.9% | 1.6%, 2.5% | | Roche cobas Integra 400 Plus | C3 (mg/dL) | 135.91 | Between Lots | 1.27 | 1.09, 1.53 | 0.9% | 0.8%, 1% | | | | | Between Tubes | 1.63 | 1.06, 2.05 | 0.9% | 0.2%, 1.3% | | | | | Within Tubes | 1.79 | 1.56, 2.11 | 1.4% | 1.2%, 1.7% | | | | | Total | 2.74 | 2.22, 3.58 | 1.9% | 1.6%, 2.5% | | Beckman Coulter AU480 | Ca (mg/dL) | 9.19 | Between Lots | 0.04 | 0.04, 0.05 | 0.5% | 0.4%, 0.6% | | | | | Between Tubes | 0 | 0, 0 | 0% | 0%, 0% | | | | | Within Tubes | 0.11 | 0.09, 0.13 | 1.2% | 1%, 1.4% | | | | | Total | 0.12 | 0.09, 0.15 | 1.2% | 1%, 1.6% | | Roche cobas Integra 400 Plus | Ca (mg/dL) | 9.569 | Between Lots | 0.014 | 0.012, 0.016 | 0.2% | 0.1%, 0.2% | | | | | Between Tubes | 0.122 | 0.088, 0.148 | 1.2% | 0.8%, 1.5% | | | | | Within Tubes | 0.114 | 0.099, 0.133 | 1.3% | 1.1%, 1.5% | | | | | Total | 0.167 | 0.136, 0.218 | 1.8% | 1.4%, 2.3% | | Beckman Coulter AU480 | CL (mmol/L) | 99.1 | Between Lots | 0.3 | 0.2, 0.3 | 0.2% | 0.2%, 0.3% | | | | | Between Tubes | 0.7 | 0.5, 0.9 | 0.7% | 0.5%, 0.9% | | | | | Within Tubes | 0.7 | 0.6, 0.8 | 0.7% | 0.6%, 0.8% | | | | | Total | 1 | 0.8, 1.4 | 1% | 0.8%, 1.3% | | Roche cobas Integra 400 Plus | CL (mmol/L) | 98.01 | Between Lots | 0.46 | 0.39, 0.55 | 0.4% | 0.4%, 0.5% | | | | | Between Tubes | 0.16 | 0, 0.36 | 0.1% | 0%, 0.4% | | | | | Within Tubes | 0.6 | 0.52, 0.7 | 0.6% | 0.5%, 0.7% | | | | | Total | 0.77 | 0.62, 1.01 | 0.8% | 0.6%, 1% | | Beckman Coulter AU480 | CORT (μg/dL) | 9.814 | Between Lots | 0.02 | 0.017, 0.024 | 1% | 0.9%, 1.2% | | | | | Between Tubes | 0.157 | 0, 0.249 | 0% | 0%, 0% | | | | | Within Tubes | 0.347 | 0.303, 0.404 | 3.6% | 3.2%, 4.2% | | | | | Total | 0.381 | 0.309, 0.495 | 3.8% | 3.1%, 4.9% | | Roche cobas e411 | CORT (μg/dL) | 9.173 | Between Lots | 0.016 | 0.014, 0.02 | 0.5% | 0.4%, 0.6% | | | | | Between Tubes | 0 | 0, 0 | 0% | 0%, 0% | | | | | Within Tubes | 0.267 | 0.233, 0.312 | 2.5% | 2.2%, 3% | | | | | Total | 0.267 | 0.216, 0.35 | 2.6% | 2.1%, 3.4% | | Beckman Coulter AU480 | Free T4 (ng/dL) | 0.912 | Between Lots | 0.012 | 0.01, 0.014 | 1.4% | 1.2%, 1.7% | | | | | Between Tubes | 0.009 | 0, 0.016 | 0% | 0%, 0% | | | | | Within Tubes | 0.025 | 0.022, 0.029 | 3.1% | 2.7%, 3.5% | | | | | Total | 0.03 | 0.024, 0.038 | 3.4% | 2.7%, 4.3% | | Roche cobas e411 | Free T4 (ng/dL) | 1.2481 | Between Lots | 0.0127 | 0.011, 0.0152 | 0.7% | 0.6%, 0.8% | | | | | Between Tubes | 0 | 0, 0 | 0% | 0%, 0% | | | | | Within Tubes | 0.0407 | 0.0356, 0.0474 | 3% | 2.6%, 3.5% | | | | | Total | 0.0426 | 0.0347, 0.0551 | 3.1% | 2.5%, 4% | K253539 - Page 9 of 41 {9} | Test System | Analyte (Unit) | Mean | Variance Component | SD | SD 95% CI | CV (%) | CV 95% CI | | --- | --- | --- | --- | --- | --- | --- | --- | | Beckman Coulter AU480 | GLUC (mg/dL) | 129.8 | Between Lots | 0.7 | 0.6, 0.8 | 0% | 0%, 0% | | | | | Between Tubes | 1.8 | 1.3, 2.2 | 1.8% | 1.5%, 2.2% | | | | | Within Tubes | 1.7 | 1.5, 2 | 1.1% | 1%, 1.3% | | | | | Total | 2.6 | 2.1, 3.4 | 2.2% | 1.8%, 2.8% | | Roche cobas Integra 400 Plus | GLUC (mg/dL) | 126.2 | Between Lots | 0.7 | 0.6, 0.8 | 0.6% | 0.5%, 0.8% | | | | | Between Tubes | 0.8 | 0, 1.6 | 1.7% | 1.2%, 2% | | | | | Within Tubes | 2.7 | 2.3, 3.1 | 1.6% | 1.4%, 1.9% | | | | | Total | 2.8 | 2.3, 3.7 | 2.4% | 2%, 3.1% | | Beckman Coulter AU480 | IgG (mg/dL) | 1121.89 8 | Between Lots | 28.203 | 24.255, 33.7 | 2.2% | 1.9%, 2.7% | | | | | Between Tubes | 0 | 0, 0 | 0% | 0%, 0% | | | | | Within Tubes | 15.201 | 13.268, 17.799 | 1.2% | 1.1%, 1.4% | | | | | Total | 32.039 | 26.031, 41.679 | 2.5% | 2.1%, 3.3% | | Roche cobas Integra 400 Plus | IgG (mg/dL) | 1184.05 | Between Lots | 11.89 | 10.22, 14.21 | 1% | 0.8%, 1.2% | | | | | Between Tubes | 0 | 0, 0 | 0% | 0%, 0% | | | | | Within Tubes | 17.9 | 15.62, 20.96 | 1.6% | 1.4%, 1.9% | | | | | Total | 21.49 | 17.44, 28 | 1.9% | 1.5%, 2.5% | | Beckman Coulter AU480 | LDH (U/L) | 149.5 | Between Lots | 0 | 0.0 | 0% | 0%, 0% | | | | | Between Tubes | 10.4 | 8.7, 11.9 | 6.8% | 5.7%, 7.7% | | | | | Within Tubes | 2 | 1.7, 2.3 | 1.2% | 1%, 1.4% | | | | | Total | 10.6 | 8.6, 13.8 | 6.9% | 5.6%, 8.9% | | Roche cobas Integra 400 Plus | LDH (U/L) | 167.55 | Between Lots | 0 | 0, 0 | 0% | 0%, 0% | | | | | Between Tubes | 6.85 | 4.51, 8.58 | 4% | 2.6%, 5% | | | | | Within Tubes | 7.05 | 6.06, 8.42 | 4.2% | 3.6%, 5% | | | | | Total | 9.83 | 7.96, 12.86 | 5.8% | 4.7%, 7.5% | | Beckman Coulter AU480 | Phos (mg/dL) | 3.48 | Between Lots | 0.04 | 0.03, 0.04 | 1% | 0.8%, 1.2% | | | | | Between Tubes | 0.07 | 0.06, 0.09 | 1.6% | 1.1%, 2% | | | | | Within Tubes | 0.05 | 0.04, 0.06 | 1.8% | 1.5%, 2.1% | | | | | Total | 0.1 | 0.08, 0.12 | 2.6% | 2.1%, 3.4% | | Roche cobas® Integra 400 Plus | Phos (mg/dL) | 3.15 | Between Lots | 0.03 | 0.03, 0.04 | 0.9% | 0.8%, 1.1% | | | | | Between Tubes | 0.05 | 0.03, 0.06 | 1.4% | 0.6%, 1.9% | | | | | Within Tubes | 0.06 | 0.05, 0.07 | 2.1% | 1.8%, 2.4% | | | | | Total | 0.08 | 0.07, 0.11 | 2.7% | 2.2%, 3.5% | | Beckman Coulter AU480 | TBIL (mg/dL) | 1.22 | Between Lots | 0.01 | 0.01, 0.01 | 0.9% | 0.8%, 1.1% | | | | | Between Tubes | 0 | 0, 0.02 | 5.7% | 4.7%, 6.5% | | | | | Within Tubes | 0.03 | 0.02, 0.03 | 1.9% | 1.6%, 2.2% | | | | | Total | 0.03 | 0.03, 0.04 | 6% | 4.9%, 8% | | Roche cobas Integra 400 Plus | TBIL (mg/dL) | 1.24 | Between Lots | 0.026 | 0.022, 0.032 | 4.3% | 3.6%, 5.1% | | | | | Between Tubes | 0.055 | 0.043, 0.064 | 5% | 2.6%, 6.6% | | | | | Within Tubes | 0.029 | 0.025, 0.035 | 6.3% | 5.4%, 7.5% | | | | | Total | 0.067 | 0.054, 0.09 | 9.1% | 7.3%, 12.1% | | Beckman Coulter AU480 | TESTO (ng/dL) | 2.565 | Between Lots | 0.055 | 0.047, 0.067 | 2.1% | 1.8%, 2.6% | | | | | Between Tubes | 0 | 0., 0 | 2.7% | 1.8%, 3.4% | | | | | Within Tubes | 0.093 | 0.08, 0.11 | 2.7% | 2.4%, 3.3% | K253539 - Page 10 of 41 {10} | Test System | Analyte (Unit) | Mean | Variance Component | SD | SD 95% CI | CV (%) | CV 95% CI | | --- | --- | --- | --- | --- | --- | --- | --- | | | | | Total | 0.108 | 0.086, 0.144 | 4.4 % | 3.5%, 5.9% | | Roche cobas e411 | TESTO (ng/dL) | 3.4577 | Between Lots | 0.0625 | 0.0513, 0.08 | 1.5 % | 1.3%, 2% | | | | | Between Tubes | 0 | 0, 0 | 0 % | 0%, 0% | | | | | Within Tubes | 0.1005 | 0.0864, 0.1201 | 2.4 % | 2.1%, 2.9% | | | | | Total | 0.1184 | 0.0901, 0.1725 | 2.8 % | 2.2%, 4.2% | | Beckman Coulter AU480 | Total T4 (μg/dL) | 9.872 | Between Lots | 0.171 | 0.147, 0.204 | 1.7% | 1.5%, 2% | | | | | Between Tubes | 0.221 | 0, 0.334 | 1.4% | 0%, 2.5% | | | | | Within Tubes | 0.443 | 0.388, 0.516 | 3.7% | 3.3%, 4.4% | | | | | Total | 0.524 | 0.426, 0.679 | 4.4% | 3.5%, 5.7% | | Roche cobas e411 | Total T4 (μg/dL) | 7.994 | Between Lots | 0.075 | 0.065, 0.09 | 0.9% | 0.8%, 1.1% | | | | | Between Tubes | 0 | 0, 0 | 0 % | 0%, 0% | | | | | Within Tubes | 0.222 | 0.194, 0.26 | 2.8 % | 2.5%, 3.3% | | | | | Total | 0.234 | 0.19, 0.306 | 3 % | 2.4%, 3.9% | | Beckman Coulter AU480 | TP (g/dL) | 7.08 | Between Lots | 0.06 | 0.05, 0.07 | 0.8% | 0.7%, 0.9% | | | | | Between Tubes | 0.04 | 0.02, 0.05 | 0.5% | 0%, 0.7% | | | | | Within Tubes | 0.06 | 0.05, 0.07 | 0.9% | 0.8%, 1% | | | | | Total | 0.09 | 0.07, 0.12 | 1.3% | 1%, 1.6% | | Roche cobas Integra 400 Plus | TP (g/dL) | 6.83 | Between Lots | 0.04 | 0.03, 0.05 | 0.6% | 0.5%, 0.7% | | | | | Between Tubes | 0.08 | 0.05, 0.09 | 0.9% | 0.4%, 1.2% | | | | | Within Tubes | 0.08 | 0.07, 0.1 | 1.3% | 1.1%, 1.5% | | | | | Total | 0.12 | 0.1, 0.16 | 1.6% | 1.3%, 2.1% | | Beckman Coulter AU480 | TPSA (ng/mL) | 3.578 | Between Lots | 0 | 0.0 | 2.9% | 2.4%, 3.7% | | | | | Between Tubes | 0.047 | 0, 0.094 | 1.3% | 0%, 2.1% | | | | | Within Tubes | 0.147 | 0.128, 0.173 | 2.9% | 2.6%, 3.4% | | | | | Total | 0.155 | 0.119, 0.221 | 4.3% | 3.3%, 6.2% | | Roche cobas® e411 | TPSA (ng/mL) | 3.9024 | Between Lots | 0.0262 | 0.0216, 0.0332 | 1.4% | 1.1%, 1.8% | | | | | Between Tubes | 0 | 0, 0 | 0% | 0%, 0% | | | | | Within Tubes | 0.1367 | 0.1187, 0.1612 | 2% | 1.7%, 2.4% | | | | | Total | 0.1392 | 0.1065, 0.2008 | 2.4% | 1.9%, 3.5% | | Beckman Coulter AU480 | Trig (mg/dL) | 187.4 | Between Lots | 1.9 | 1.6, 2.3 | 1.1 % | 1%, 1.4% | | | | | Between Tubes | 1.7 | 0, 2.6 | 1.6 % | 1.2%, 2% | | | | | Within Tubes | 3.2 | 2.3, 3.9 | 1.2 % | 1.1%, 1.5% | | | | | Total | 4.1 | 3.3, 5.5 | 2.4 % | 1.9%, 3.1% | | Roche cobas Integra 400 Plus | Trig (mg/dL) | 186.2 | Between Lots | 1.8 | 1.5, 2.1 | 0 % | 0%, 0% | | | | | Between Tubes | 5.7 | 4.5, 6.7 | 4.4 % | 3.6%, 5.2% | | | | | Within Tubes | 3.4 | 2.9, 4.1 | 2.2 % | 1.9%, 2.6% | | | | | Total | 6.8 | 5.5, 9.1 | 5 % | 4%, 6.6% | BD Vacutainer® Serum Glass Blood Collection Tubes Blood was collected from each subject (n=39) into 6 BD Vacutainer® Serum Glass tubes. K253539 - Page 11 of 41 {11} Specimens were tested in duplicate per tube with 2 tubes per lot across 3 lots on two instrument platforms (except for C3) for the following select routine and special chemistry analytes: ALT, C3, Ca, CL, CORT, GLUC, IgG, K, LDH, Phos, Free T4, Total T4, TBIL, TESTO, TP, TPSA and Trig. Contrived samples (less than 15%) were also used to cover the clinically relevant range for some analytes as necessary. Total, Between-Lot, Between-Tube, and Within-Tube variability for each instrument platform are presented in the tables below: | Test System | Analyte (Unit) | Mean | Variance Component | SD | SD 95% CI | CV (%) | CV 95% CI | | --- | --- | --- | --- | --- | --- | --- | --- | | Siemens Atellica | ALT (U/L) | 36.2 | Between Lots | 0.5 | 0.4, 0.6 | 1.4% | 1.2%, 1.7% | | | | | Between Tubes | 0.2 | 0, 0.4 | 0.0% | 0.0%, 0.0% | | | | | Within Tubes | 0.6 | 0.6, 0.7 | 2.6% | 2.4%, 2.9% | | | | | Total | 0.8 | 0.7, 1.1 | 3.0% | 2.4%, 3.9% | | Roche cobas 6000 | ALT (U/L) | 31 | Between Lots | 0.4 | 0.4, 0.5 | 1.5% | 1.3%, 1.8% | | | | | Between Tubes | 0.2 | 0.1, 0.3 | 0.9% | 0.4%, 1.2% | | | | | Within Tubes | 0.4 | 0.4, 0.4 | 1.6% | 1.5%, 1.8% | | | | | Total | 0.6 | 0.5, 0.9 | 2.4% | 1.9%, 3.1% | | Roche cobas 6000 | C3 (mg/dL) | 136.2 | Between Lots | 1.8 | 1.6, 2.2 | 1.3% | 1.1%, 1.6% | | | | | Between Tubes | 1.4 | 1.1, 1.7 | 1.0% | 0.8%, 1.3% | | | | | Within Tubes | 1.6 | 1.5, 1.8 | 1.2% | 1.1%, 1.3% | | | | | Total | 2.9 | 2.3, 3.7 | 2.1% | 1.7%, 2.7% | | Siemens Atellica | Ca (mg/dL) | 9.56 | Between Lots | 0.04 | 0.03, 0.04 | 0.4% | 0.3%, 0.4% | | | | | Between Tubes | 0.04 | 0.01, 0.06 | 0.5% | 0.2%, 0.7% | | | | | Within Tubes | 0.09 | 0.08, 0.1 | 1.0% | 0.9%, 1.1% | | | | | Total | 0.11 | 0.09, 0.14 | 1.1% | 0.9%, 1.4% | | Roche cobas 6000 | Ca (mg/dL) | 9.47 | Between Lots | 0.04 | 0.03, 0.04 | 0.4% | 0.3%, 0.5% | | | | | Between Tubes | 0.04 | 0.01, 0.05 | 0.4% | 0.2%, 0.6% | | | | | Within Tubes | 0.08 | 0.07, 0.08 | 0.8% | 0.7%, 0.9% | | | | | Total | 0.09 | 0.07, 0.12 | 1.0% | 0.8%, 1.3% | | Siemens Atellica | CL (mmol/L) | 103.89 | Between Lots | 0.21 | 0.18, 0.25 | 0.2% | 0.2%, 0.2% | | | | | Between Tubes | 0.22 | 0.11, 0.3 | 0.2% | 0.1%, 0.3% | | | | | Within Tubes | 0.39 | 0.36, 0.44 | 0.4% | 0.3%, 0.4% | | | | | Total | 0.5 | 0.41, 0.65 | 0.5% | 0.4%, 0.6% | | Roche cobas 6000 | CL (mmol/L) | 102.7 | Between Lots | 0.21 | 0.18, 0.25 | 0.2% | 0.2%, 0.2% | | | | | Between Tubes | 0 | 0.0 | 0.0% | 0.0%, 0.0% | | | | | Within Tubes | 0.57 | 0.52, 0.63 | 0.6% | 0.5%, 0.6% | | | | | Total | 0.61 | 0.5, 0.78 | 0.6% | 0.5%, 0.8% | | Siemens Atellica | CORT (μg/dL) | 11.653 | Between Lots | 0.566 | 0.486, 0.678 | 4.2% | 3.6%, 5.0% | | | | | Between Tubes | 0.331 | 0.265, 0.386 | 2.6% | 2.1%, 3.0% | | | | | Within Tubes | 0.26 | 0.237, 0.288 | 2.0% | 1.8%, 2.2% | | | | | Total | 0.705 | 0.573, 0.917 | 5.3% | 4.3%, 6.9% | | Roche cobas 6000 | CORT (μg/dL) | 12.826 | Between Lots | 0.536 | 0.46, 0.642 | 3.6% | 3.1%, 4.3% | | | | | Between Tubes | 0.339 | 0.262, 0.402 | 1.9% | 1.4%, 2.3% | | | | | Within Tubes | 0.321 | 0.293, 0.355 | 2.1% | 1.9%, 2.3% | | | | | Total | 0.711 | 0.576, 0.928 | 4.6% | 3.7%, 6.0% | | Siemens Atellica | Free T4 (ng/dL) | 1.178 | Between Lots | 0.017 | 0.014, 0.02 | 1.6% | 1.3%, 1.9% | | | | | Between Tubes | 0.015 | 0.01, 0.019 | 1.2% | 0.8%, 1.5% | K253539 - Page 12 of 41 {12} | Test System | Analyte (Unit) | Mean | Variance Component | SD | SD 95% CI | CV (%) | CV 95% CI | | --- | --- | --- | --- | --- | --- | --- | --- | | | | | Within Tubes | 0.02 | 0.018, 0.022 | 1.7% | 1.6%, 1.9% | | | | | Total | 0.03 | 0.025, 0.039 | 2.6% | 2.2%, 3.4% | | Roche cobas 6000 | Free T4 (ng/dL) | 1.2651 | Between Lots | 0.0072 | 0.0062, 0.0087 | 0.6% | 0.5%, 0.7% | | | | | Between Tubes | 0 | 0.0 | 0.0% | 0.0%, 0.0% | | | | | Within Tubes | 0.0207 | 0.0189, 0.0228 | 1.6% | 1.5%, 1.8% | | | | | Total | 0.0219 | 0.0177, 0.0285 | 1.7% | 1.4%, 2.2% | | Siemens Atellica | GLUC (mg/dL) | 89.2 | Between Lots | 2.4 | 2, 2.8 | 3.4% | 2.9%, 4.1% | | | | | Between Tubes | 1.6 | 1.3, 1.8 | 1.8% | 1.5%, 2.0% | | | | | Within Tubes | 0.5 | 0.5, 0.6 | 0.6% | 0.5%, 0.6% | | | | | Total | 2.9 | 2.3, 3.7 | 3.9% | 3.2%, 5.0% | | Roche cobas 6000 | GLUC (mg/dL) | 90.8 | Between Lots | 2.6 | 2.2, 3.1 | 3.6% | 3.1%, 4.3% | | | | | Between Tubes | 1.6 | 1.3, 1.8 | 1.7% | 1.4%, 2.0% | | | | | Within Tubes | 1 | 0.9, 1.1 | 1.1% | 1.0%, 1.2% | | | | | Total | 3.2 | 2.6, 4.2 | 4.2% | 3.4%, 5.4% | | Siemens Atellica | IgG (mg/dL) | 1141.5 | Between Lots | 19.2 | 16.5, 23 | 1.4% | 1.2%, 1.6% | | | | | Between Tubes | 16.4 | 12.5, 19.5 | 1.3% | 0.9%, 1.5% | | | | | Within Tubes | 16.1 | 14.7, 17.8 | 1.4% | 1.3%, 1.6% | | | | | Total | 30 | 24.3, 39.1 | 2.3% | 1.9%, 3.1% | | Roche cobas 6000 | IgG (mg/dL) | 1136.6 | Between Lots | 15.1 | 12.9, 18 | 1.1% | 1.0%, 1.3% | | | | | Between Tubes | 14.5 | 10.5, 17.6 | 1.0% | 0.7%, 1.3% | | | | | Within Tubes | 17.1 | 15.6, 18.9 | 1.4% | 1.3%, 1.6% | | | | | Total | 27 | 21.9, 35.3 | 2.1% | 1.7%, 2.7% | | Siemens Atellica | LDH (U/L) | 182.5 | Between Lots | 6 | 5.1, 7.1 | 3.2% | 2.7%, 3.8% | | | | | Between Tubes | 4.8 | 4.1, 5.4 | 2.7% | 2.3%, 3.0% | | | | | Within Tubes | 1.3 | 1.2, 1.4 | 0.7% | 0.6%, 0.8% | | | | | Total | 7.8 | 6.3, 10 | 4.2% | 3.4%, 5.4% | | Roche cobas 6000 | LDH (U/L) | 190.4 | Between Lots | 5.9 | 5.1, 7.1 | 3.0% | 2.6%, 3.6% | | | | | Between Tubes | 4.7 | 3.9, 5.4 | 2.5% | 2.1%, 2.9% | | | | | Within Tubes | 2.5 | 2.3, 2.8 | 1.3% | 1.2%, 1.4% | | | | | Total | 7.9 | 6.5, 10.3 | 4.2% | 3.4%, 5.4% | | Siemens Atellica | Phos (mg/dL) | 3.27 | Between Lots | 0.01 | 0.01, 0.02 | 0.4% | 0.3%, 0.4% | | | | | Between Tubes | 0.02 | 0.01, 0.03 | 0.7% | 0.3%, 0.9% | | | | | Within Tubes | 0.04 | 0.04, 0.04 | 1.3% | 1.2%, 1.4% | | | | | Total | 0.05 | 0.04, 0.06 | 1.5% | 1.2%, 2.0% | | Roche cobas 6000 | Phos (mg/dL) | 3.2 | Between Lots | 0.02 | 0.02, 0.03 | 0.7% | 0.6%, 0.8% | | | | | Between Tubes | 0.02 | 0.01, 0.03 | 0.7% | 0.1%, 0.9% | | | | | Within Tubes | 0.04 | 0.04, 0.05 | 1.4% | 1.3%, 1.6% | | | | | Total | 0.05 | 0.04, 0.07 | 1.7% | 1.4%, 2.2% | | Siemens Atellica | TBIL (mg/dL) | 0.7702 | Between Lots | 0.0114 | 0.0098, 0.0137 | 1.4% | 1.2%, 1.7% | | | | | Between Tubes | 0.008 | 0.0066, 0.0092 | 1.0% | 0.8%, 1.2% | K253539 - Page 13 of 41 {13} | Test System | Analyte (Unit) | Mean | Variance Component | SD | SD 95% CI | CV (%) | CV 95% CI | | --- | --- | --- | --- | --- | --- | --- | --- | | | | | Within Tubes | 0.0047 | 0.0043, 0.0052 | 0.7% | 0.6%, 0.7% | | | | | Total | 0.0147 | 0.0119, 0.0193 | 1.9% | 1.5%, 2.4% | | Roche cobas 6000 | TBIL (mg/dL) | 0.59 | Between Lots | 0 | 0, 0 | 0.6% | 0.5%, 0.7% | | | | | Between Tubes | 0.01 | 0, 0.02 | 1.9% | 0.0%, 3.1% | | | | | Within Tubes | 0.03 | 0.03, 0.03 | 5.5% | 5.0%, 6.1% | | | | | Total | 0.03 | 0.03, 0.04 | 5.9% | 4.8%, 7.7% | | Siemens Atellica | TESTO (ng/dL) | 331.538 | Between Lots | 6.612 | 5.675, 7.922 | 2.0% | 1.8%, 2.5% | | | | | Between Tubes | 5.46 | 3.308, 6.977 | 2.0% | 1.5%, 2.4% | | | | | Within Tubes | 8.343 | 7.614, 9.228 | 2.0% | 1.8%, 2.2% | | | | | Total | 11.964 | 9.681, 15.666 | 3.5% | 2.8%, 4.6% | | Roche cobas 6000 | TESTO (ng/dL) | 353.437 | Between Lots | 6.456 | 5.541, 7.736 | 3.5% | 3.0%, 4.2% | | | | | Between Tubes | 2.984 | 0, 5.244 | 0.0% | 0.0%, 0.0% | | | | | Within Tubes | 9.983 | 9.112, 11.038 | 5.9% | 5.4%, 6.6% | | | | | Total | 12.257 | 9.918, 16.051 | 6.9% | 5.6%, 9.1% | | Siemens Atellica | Total T4 (μg/dL) | 7.57 | Between Lots | 0.09 | 0.08, 0.11 | 1.4% | 1.2%, 1.7% | | | | | Between Tubes | 0.11 | 0.05, 0.14 | 1.4% | 0.7%, 1.9% | | | | | Within Tubes | 0.19 | 0.17, 0.21 | 2.6% | 2.4%, 2.9% | | | | | Total | 0.23 | 0.19, 0.3 | 3.3% | 2.7%, 4.2% | | Roche cobas 6000 | Total T4 (μg/dL) | 7.324 | Between Lots | 0.036 | 0.031, 0.043 | 0.5% | 0.4%, 0.6% | | | | | Between Tubes | 0.054 | 0, 0.087 | 0.8% | 0.0%, 1.3% | | | | | Within Tubes | 0.157 | 0.143, 0.173 | 2.1% | 1.9%, 2.4% | | | | | Total | 0.17 | 0.138, 0.22 | 2.3% | 1.9%, 3.0% | | Siemens Atellica | TP (g/dL) | 7.43 | Between Lots | 0.09 | 0.08, 0.11 | 1.2% | 1.1%, 1.5% | | | | | Between Tubes | 0.07 | 0.06, 0.08 | 1.0% | 0.8%, 1.1% | | | | | Within Tubes | 0.03 | 0.03, 0.04 | 0.4% | 0.4%, 0.5% | | | | | Total | 0.12 | 0.1, 0.16 | 1.6% | 1.3%, 2.1% | | Roche cobas 6000 | TP (g/dL) | 7.5 | Between Lots | 0.1 | 0.08, 0.11 | 1.3% | 1.1%, 1.5% | | | | | Between Tubes | 0.06 | 0.04, 0.08 | 0.8% | 0.4%, 1.0% | | | | | Within Tubes | 0.09 | 0.08, 0.1 | 1.2% | 1.1%, 1.3% | | | | | Total | 0.14 | 0.12, 0.18 | 1.9% | 1.6%, 2.4% | | Siemens Atellica | TPSA (ng/mL) | 2.083 | Between Lots | 0.055 | 0.046, 0.066 | 3.2% | 2.7%, 3.8% | | | | | Between Tubes | 0.027 | 0.017, 0.035 | 4.1% | 3.2%, 4.8% | | | | | Within Tubes | 0.037 | 0.033, 0.041 | 3.0% | 2.7%, 3.4% | | | | | Total | 0.071 | 0.057, 0.095 | 6.0% | 4.8%, 8.0% | | Roche cobas 6000 | TPSA (ng/mL) | 2.997 | Between Lots | 0.0348 | 0.0292, 0.043 | 1.2% | 1.0%, 1.5% | | | | | Between Tubes | 0.0159 | 0, 0.0342 | 0.3% | 0.0%, 0.9% | | | | | Within Tubes | 0.0664 | 0.0598, 0.0747 | 1.9% | 1.8%, 2.2% | | | | | Total | 0.0767 | 0.0601, 0.1058 | 2.3% | 1.8%, 3.2% | | Siemens Atellica | Trig (mg/dL) | 136 | Between Lots | 1.7 | 1.5, 2.1 | 2.0% | 1.7%, 2.4% | | | | | Between Tubes | 1.7 | 1.4, 1.9 | 1.0% | 0.9%, 1.2% | | | | | Within Tubes | 0.8 | 0.7, 0.9 | 0.7% | 0.6%, 0.8% | | | | | Total | 2.5 | 2.1, 3.3 | 2.4% | 1.9%, 3.1% | K253539 - Page 14 of 41 {14} | Test System | Analyte (Unit) | Mean | Variance Component | SD | SD 95% CI | CV (%) | CV 95% CI | | --- | --- | --- | --- | --- | --- | --- | --- | | Roche cobas 6000 | Trig (mg/dL) | 138.8 | Between Lots | 1.8 | 1.5, 2.1 | 2.0% | 1.7%, 2.4% | | | | | Between Tubes | 1.2 | 0.8, 1.5 | 0.8% | 0.5%, 1.1% | | | | | Within Tubes | 1.8 | 1.6, 1.9 | 1.2% | 1.1%, 1.3% | | | | | Total | 2.8 | 2.3, 3.7 | 2.5% | 2.0%, 3.3% | # BD Vacutainer® RST Blood Collection Tubes Blood was collected from each subject (n=66) into 6 BD Vacutainer® RST Tubes. Specimens were tested with 2 tubes per lot across 3 lots on 2 instrument platforms for the following select routine and special chemistry analytes: ALT, C3, Ca, CL, CORT, Free T4, GLUC, IgG, K, LDH, Phos, Free T4, Total T4, TBIL, TESTO, TP, TPSA and Trig. Contrived samples (less than 15%) were also used to cover the clinically relevant range for some analytes as necessary. Total, Between-Lot, Between-Tube, and Within-Tube variability for each instrument platform are presented in the tables below: | Test System | Analyte (Unit) | Mean | Variance Component | SD | SD 95% CI | CV (%) | CV 95% CI | | --- | --- | --- | --- | --- | --- | --- | --- | | Beckman Coulter AU480 | ALT (U/L) | 30.2 | Between Lots | 0 | 0, 0 | 0.3 % | 0.3%, 0.4% | | | | | Between Tubes | 0.4 | 0, 0.7 | 2.8% | 1.9%, 3.5% | | | | | Within Tubes | 0.9 | 0.8, 1.1 | 2.6% | 2.2%, 3.2% | | | | | Total | 1 | 0.8, 1.3 | 3.8 % | 3.1%, 5.1% | | Roche cobas Integra 400 Plus | ALT (U/L) | 30.26 | Between Lots | 0.38 | 0.32, 0.46 | 0 % | 0%, 0% | | | | | Between Tubes | 0.34 | 0, 0.51 | 3.4 % | 2.5%, 4.1% | | | | | Within Tubes | 0.59 | 0.5, 0.71 | 2.6 % | 2.2%, 3.1% | | | | | Total | 0.78 | 0.62, 1.04 | 4.3 % | 3.4%, 5.7% | | Beckman Coulter AU480 | TBIL (mg/dL) | 1.88 | Between Lots | 0 | 0, 0 | 0 % | 0%, 0% | | | | | Between Tubes | 0.02 | 0.01, 0.03 | 6.2 % | 5.1%, 7.1% | | | | | Within Tubes | 0.03 | 0.02, 0.03 | 1.8 % | 1.5%, 2.1% | | | | | Total | 0.03 | 0.03, 0.05 | 6.4 % | 5.1%, 8.5% | | Roche cobas Integra 400 Plus | TBIL (mg/dL) | 2.074 | Between Lots | 0.025 | 0.021, 0.03 | 0 % | 0%, 0% | | | | | Between Tubes | 0.074 | 0.058, 0.086 | 5.9 % | 4.5%, 7.1% | | | | | Within Tubes | 0.036 | 0.031, 0.043 | 3.8 % | 3.3%, 4.5% | | | | | Total | 0.086 | 0.068, 0.116 | 7.1 % | 5.6%, 9.5% | | Roche cobas Integra 400 Plus | C3 (mg/dL) | 140 | Between Lots | 0.5 | 0.4, 0.6 | 0.4 % | 0.3%, 0.5% | | | | | Between Tubes | 0 | 0, 0 | 0 % | 0%, 0% | | | | | Within Tubes | 2.3 | 2, 2.7 | 1.5 % | 1.3%, 1.8% | | | | | Total | 2.4 | 1.9, 3.1 | 1.6 % | 1.3%, 2.1% | | Roche cobas Integra 400 Plus | C3 (mg/dL) | 128.48 | Between Lots | 1.05 | 0.9, 1.26 | 0.7 % | 0.6%, 0.8% | | | | | Between Tubes | 0.6 | 0, 1.11 | 0.4 % | 0%, 0.8% | | | | | Within Tubes | 1.66 | 1.45, 1.96 | 1.3 % | 1.2%, 1.6% | | | | | Total | 2.06 | 1.66, 2.7 | 1.5 % | 1.2%, 2% | | Beckman Coulter AU480 | Ca (mg/dL) | 9.61 | Between Lots | 0.01 | 0.01, 0.01 | 0.1 % | 0.1%, 0.1% | | | | | Between Tubes | 0.01 | 0, 0.05 | 0.3 % | 0%, 0.6% | | | | | Within Tubes | 0.1 | 0.09, 0.11 | 1 % | 0.9%, 1.1% | | | | | Total | 0.1 | 0.08, 0.13 | 1 % | 0.8%, 1.3% | | | Ca (mg/dL) | 9.574 | Between Lots | 0 | 0, 0 | 0 % | 0%, 0% | K253539 - Page 15 of 41 {15} | Test System | Analyte (Unit) | Mean | Variance Component | SD | SD 95% CI | CV (%) | CV 95% CI | | --- | --- | --- | --- | --- | --- | --- | --- | | Roche cobas Integra 400 Plus | | | Between Tubes | 0.037 | 0, 0.076 | 0 % | 0%, 0% | | | | | Within Tubes | 0.122 | 0.107, 0.143 | 1.4 % | 1.2%, 1.6% | | | | | Total | 0.128 | 0.103, 0.167 | 1.4 % | 1.1%, 1.8% | | Beckman Coulter AU480 | CL (mmol/L) | 99.5 | Between Lots | 0.8 | 0.6, 0.9 | 0.4 % | 0.4%, 0.5% | | | | | Between Tubes | 0.6 | 0.5, 0.7 | 0.7 % | 0.6%, 0.9% | | | | | Within Tubes | 1.1 | 0.9, 1.4 | 0.6 % | 0.5%, 0.7% | | | | | Total | 1.1 | 0.9, 1.4 | 1 % | 0.8%, 1.4% | | Roche cobas Integra 400 Plus | CL (mmol/L) | 100.98 | Between Lots | 0.59 | 0.51, 0.72 | 1.1% | 1%, 1.3% | | | | | Between Tubes | 0 | 0, 0 | 0% | 0%, 0% | | | | | Within Tubes | 2.78 | 2.4, 3.3 | 5.1% | 4.4%, 6.1% | | | | | Total | 2.84 | 2.29, 3.73 | 5.3% | 4.3%, 6.8% | | Beckman Coulter AU480 | CORT (μg/dL) | 9.051 | Between Lots | 0 | 0, 0 | 0% | 0%, 0% | | | | | Between Tubes | 0.255 | 0.142, 0.332 | 3% | 1.9%, 3.8% | | | | | Within Tubes | 0.317 | 0.274, 0.376 | 3.2% | 2.8%, 3.8% | | | | | Total | 0.407 | 0.328, 0.537 | 4.4% | 3.5%, 5.8% | | Roche cobas e411 | CORT (μg/dL) | 8.902 | Between Lots | 0.323 | 0.276, 0.389 | 2.2% | 1.9%, 2.7% | | | | | Between Tubes | 0.139 | 0, 0.205 | 0.8% | 0%, 1.8% | | | | | Within Tubes | 0.248 | 0.214, 0.294 | 2.8% | 2.5%, 3.4% | | | | | Total | 0.43 | 0.346, 0.568 | 3.7% | 3%, 4.9% | | Beckman Coulter AU480 | Free T4 (ng/dL) | 0.882 | Between Lots | 0.013 | 0.011, 0.015 | 1.5% | 1.3%, 1.8% | | | | | Between Tubes | 0.014 | 0, 0.02 | 1.1% | 0%, 2% | | | | | Within Tubes | 0.024 | 0.021, 0.028 | 2.9% | 2.5%, 3.5% | | | | | Total | 0.031 | 0.025, 0.04 | 3.5% | 2.8%, 4.5% | | Roche cobas e411 | Free T4 (ng/dL) | 1.2538 | Between Lots | 0.0169 | 0.0145, 0.0203 | 1.2% | 1%, 1.4% | | | | | Between Tubes | 0 | 0, 0 | 0% | 0%, 0% | | | | | Within Tubes | 0.0363 | 0.0315, 0.0427 | 2.8% | 2.4%, 3.3% | | | | | Total | 0.04 | 0.0325, 0.052 | 3% | 2.5%, 3.9% | | Beckman Coulter AU480 | GLUC (mg/dL) | 137.4 | Between Lots | 0.8 | 0.7, 0.9 | 1% | 0.9%, 1.2% | | | | | Between Tubes | 0.8 | 0, 1.4 | 1.6% | 1.3%, 2% | | | | | Within Tubes | 2.1 | 1.8, 2.5 | 1.2% | 1.1%, 1.4% | | | | | Total | 2.4 | 1.9, 3.1 | 2.3% | 1.9%, 3% | | Roche cobas Integra 400 Plus | GLUC (mg/dL) | 133.5 | Between Lots | 0.5 | 0.5, 0.6 | 0.5% | 0.4%, 0.6% | | | | | Between Tubes | 1.5 | 1.1, 1.9 | 1.8% | 1.5%, 2.1% | | | | | Within Tubes | 1.5 | 1.3, 1.8 | 0.9% | 0.8%, 1% | | | | | Total | 2.2 | 1.8, 2.9 | 2.1% | 1.7%, 2.7% | | Beckman Coulter AU480 | IgG (mg/dL) | 1247.448 | Between Lots | 5.978 | 5.12, 7.184 | 0.4% | 0.3%, 0.5% | | | | | Between Tubes | 12.471 | 3.307, 17.323 | 1.0% | 0.4%, 1.3% | | | | | Within Tubes | 19.588 | 17.021, 23.073 | 1.4% | 1.2%, 1.7% | | | | | Total | 23.978 | 19.363, 31.5 | 1.8% | 1.4%, 2.3% | | Roche cobas | IgG (mg/dL) | 1257.89 | Between Lots | 9.89 | 8.48, 11.89 | 1% | 0.8%, 1.2% | | | | | Between Tubes | 14.13 | 9.08, 17.8 | 0.9% | 0.4%, 1.2% | | | | | Within Tubes | 15.66 | 13.61, 18.44 | 1.3% | 1.1%, 1.5% | K253539 - Page 16 of 41 {16} | Test System | Analyte (Unit) | Mean | Variance Component | SD | SD 95% CI | CV (%) | CV 95% CI | | --- | --- | --- | --- | --- | --- | --- | --- | | Integra 400 Plus | | | Total | 23.3 | 18.81, 30.62 | 1.8% | 1.5%, 2.4% | | Beckman Coulter AU480 | K (mmol/L) | 4.93 | Between Lots | 0.02 | 0.02, 0.02 | 0.3% | 0.3%, 0.4% | | | | | Between Tubes | 0.11 | 0.09, 0.13 | 2.7% | 2.2%, 3.1% | | | | | Within Tubes | 0.05 | 0.04, 0.06 | 1.1% | 0.9%, 1.2% | | | | | Total | 0.12 | 0.1, 0.16 | 2.9% | 2.3%, 3.8% | | Roche cobas Integra 400 Plus | K (mmol/L) | 4.977 | Between Lots | 0.013 | 0.011, 0.016 | 0.2% | 0.2%, 0.2% | | | | | Between Tubes | 0.097 | 0.074, 0.155 | 2.6% | 2.1%, 3% | | | | | Within Tubes | 0.075 | 0.066, 0.088 | 0.9% | 0.8%, 1.1% | | | | | Total | 0.123 | 0.1, 0.161 | 2.8% | 2.2%, 3.6% | | Beckman Coulter AU480 | LDH (U/L) | 142.8 | Between Lots | 0.4 | 0.4, 0.5 | 0.4% | 0.3%, 0.5% | | | | | Between Tubes | 4.5 | 3.5, 5.3 | 2.9% | 2.3%, 3.4% | | | | | Within Tubes | 2.4 | 2, 2.9 | 1.5% | 1.3%, 1.9% | | | | | Total | 5.1 | 4.1, 6.9 | 3.3% | 2.7%, 4.5% | | Roche cobas Integra 400 Plus | LDH (U/L) | 162.24 | Between Lots | 0.77 | 0.65, 0.94 | 0.5% | 0.5%, 0.6% | | | | | Between Tubes | 4.61 | 3.7, 5.37 | 2.6% | 2.1%, 3.1% | | | | | Within Tubes | 2.05 | 1.74, 2.49 | 1.4% | 1.2%, 1.7% | | | | | Total | 5.1 | 4.07, 6.84 | 3% | 2.4%, 4% | | Beckman Coulter AU480 | Phos (mg/dL) | 3.6 | Between Lots | 0.02 | 0.01, 0.02 | 0.3% | 0.3%, 0.4% | | | | | Between Tubes | 0.05 | 0.03, 0.06 | 1.2% | 0.6%, 1.6% | | | | | Within Tubes | 0.05 | 0.04, 0.06 | 1.7% | 1.5%, 2% | | | | | Total | 0.07 | 0.06, 0.09 | 2.1% | 1.7%, 2.7% | | Roche cobas Integra 400 Plus | Phos (mg/dL) | 3.39 | Between Lots | 0.01 | 0.01, 0.01 | 0.3% | 0.3%, 0.4% | | | | | Between Tubes | 0.08 | 0.07, 0.1 | 2.3% | 1.9%, 2.7% | | | | | Within Tubes | 0.05 | 0.04, 0.05 | 1.4% | 1.2%, 1.6% | | | | | Total | 0.1 | 0.08, 0.13 | 2.7% | 2.2%, 3.5% | | Beckman Coulter AU480 | TESTO (ng/dL) | 1.919 | Between Lots | 0.004 | 0.003, 0.005 | 3.4% | 2.9%, 4.2% | | | | | Between Tubes | 0 | 0, 0 | 2.6% | 0%, 4% | | | | | Within Tubes | 0.081 | 0.069, 0.097 | 4.8% | 4.1%, 5.7% | | | | | Total | 0.081 | 0.064, 0.109 | 6.4% | 5.1%, 8.7% | | Roche cobas e411 | TESTO (ng/dL) | 2.805 | Between Lots | 0 | 0, 0 | 0.7% | 0.6%, 0.9% | | | | | Between Tubes | 0.0759 | 0.0452, 0.0974 | 2.8% | 1.9%, 3.5% | | | | | Within Tubes | 0.0695 | 0.0566, 0.0868 | 2.1% | 1.7%, 2.6% | | | | | Total | 0.1023 | 0.0787, 0.146 | 3.6% | 2.7%, 5.1% | | Beckman Coulter AU480 | Total T4 (μg/dL) | 9.939 | Between Lots | 0.501 | 0.403, 0.662 | 1.6% | 1.4%, 1.9% | | | | | Between Tubes | 0.217 | 0.185, 0.264 | 2.9% | 1.6%, 3.8% | | | | | Within Tubes | 0.269 | 0.112, 0.363 | 3.5% | 3%, 4.2% | | | | | Total | 0.363 | 0.31, 0.437 | 4.8% | 3.9%, 6.3% | | Roche cobas e411 | Total T4 (μg/dL) | 8.526 | Between Lots | 0.258 | 0.22, 0.313 | 2.4% | 2%, 2.9% | | | | | Between Tubes | 0.219 | 0.093, 0.295 | 0% | 0%, 0% | | | | | Within Tubes | 0.294 | 0.251, 0.354 | 4% | 3.4%, 4.8% | | | | | Total | 0.448 | 0.36, 0.593 | 4.7% | 3.8%, 6.2% | | | | | Between Lots | 0.03 | 0.03, 0.04 | 0.5% | 0.4%, 0.5% | K253539 - Page 17 of 41 {17} | Test System | Analyte (Unit) | Mean | Variance Component | SD | SD 95% CI | CV (%) | CV 95% CI | | --- | --- | --- | --- | --- | --- | --- | --- | | Beckman Coulter AU480 | TP (g/dL) | 7.27 | Between Tubes | 0.08 | 0.06, 0.09 | 1% | 0.7%, 1.2% | | | | | Within Tubes | 0.06 | 0.05, 0.07 | 0.9% | 0.7%, 1% | | | | | Total | 0.1 | 0.08, 0.14 | 1.4% | 1.1%, 1.8% | | Roche cobas Integra 400 Plus | TP (g/dL) | 6.92 | Between Lots | 0.04 | 0.03, 0.05 | 0.6% | 0.5%, 0.7% | | | | | Between Tubes | 0.07 | 0.05, 0.09 | 0.9% | 0.7%, 1.1% | | | | | Within Tubes | 0.06 | 0.05, 0.07 | 0.8% | 0.7%, 1% | | | | | Total | 0.1 | 0.08, 0.13 | 1.4% | 1.1%, 1.8% | | Beckman Coulter AU480 | TPSA (ng/mL) | 2.277 | Between Lots | 0 | 0, 0 | 1.4% | 1.1%, 1.7% | | | | | Between Tubes | 0 | 0.0 | 1.3% | 0%, 2.1% | | | | | Within Tubes | 0.209 | 0.182, 0.247 | 2.9% | 2.5%, 3.4% | | | | | Total | 0.209 | 0.161, 0.299 | 3.4% | 2.6%, 4.9% | | Roche cobas e411 | TPSA (ng/mL) | 2.5856 | Between Lots | 0.0006 | 0.0005, 0.0008 | 0.4% | 0.3%, 0.5% | | | | | Between Tubes | 0 | 0, 0 | 1.3% | 0.9%, 1.7% | | | | | Within Tubes | 0.0939 | 0.0816, 0.1106 | 1.3% | 1.2%, 1.6% | | | | | Total | 0.0939 | 0.0722, 0.1341 | 1.9% | 1.5%, 2.8% | | Beckman Coulter AU480 | Trig (mg/dL) | 188.8 | Between Lots | 4.7 | 4, 5.8 | 0.3% | 0.2%, 0.3% | | | | | Between Tubes | 3.5 | 2.6, 4.2 | 1.5% | 1%, 1.9% | | | | | Within Tubes | 2.6 | 2.2, 3.1 | 1.4% | 1.2%, 1.7% | | | | | Total | 6.4 | 5.1, 8.6 | 2.1% | 1.7%, 2.8% | | Roche cobas Integra 400 Plus | Trig (mg/dL) | 176.6 | Between Lots | 3.7 | 3.2, 4.5 | 0.5% | 0.4%, 0.6% | | | | | Between Tubes | 2.6 | 2, 3.1 | 1.3% | 0.9%, 1.6% | | | | | Within Tubes | 1.7 | 1.5, 2.1 | 1.2% | 1.1%, 1.5% | | | | | Total | 4.9 | 3.9, 6.6 | 1.9% | 1.5%, 2.5% | ## 2. Linearity: Not applicable. ## 3. Analytical Specificity/Interference: Benchtop studies were conducted to evaluate interference from stopper materials over the sample storage time. Study protocols, acceptance criteria, and results for this study were provided and found to be acceptable. ## 4. Detection Limit and Assay Reportable Range: Not applicable. ## 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods): ### a. Specimen Stability Multiple analyte stability studies were conducted to assess the analyte within-tube stability for representative analytes in BD Vacutainer® RST™ Blood Collection Tubes. K253539 - Page 18 of 41 {18} Within-tube stability was assessed in the BD Vacutainer® RST™ Tubes after 6 hours storage at room temperature for progesterone, 12 hours storage at room temperature for CO₂, LDL and triglycerides, and for all other analytes listed below after 24-hour storage at room temperature. In addition, within tube stability after 3 days of refrigerated and 7 days of refrigerated storage was assessed for all analytes except CO₂, GLUC, HDL and LDL. Stability was also assessed in the BD Vacutainer® Serum Plastic Blood Collection Tubes and the BD Vacutainer® Serum Glass Blood Collection Tubes after 2 hour storage at room temperature for all analytes. Samples tested had analyte concentrations that covered the measuring range for the assays used for testing each analyte and important medical decision levels for each tested analyte. The study protocols and acceptance criteria have been reviewed and found to be acceptable. These studies support the storage claims included in the devices' labeling. | Analyte | Temperature Condition | Storage Duration | | --- | --- | --- | | CO₂ | Room temperature (23-27°C) | 12 hours | | ALB ALKP ALT AMY AST BUN C3 Ca Chol CK CKMB CL CORT Creat CRP DBIL E2 Fe FERR Folate Free T3 Free T4 FSH GGT GLUC HAPTO HCG HDL hsTnI | Room temperature (23-27°C) | 24 hours | K253539 - Page 19 of 41 {19} | Analyte | Temperature Condition | Storage Duration | | --- | --- | --- | | IgA | | | | IgG | | | | IgM | | | | K | | | | LDH | | | | LDL | | | | LH | | | | Lip | | | | Mg | | | | Na | | | | NT-proBNP | | | | Phos | | | | PROG | | | | RF | | | | TBIL | | | | TESTO | | | | TnT | | | | Total T3 | | | | Total T4 | | | | TP | | | | TPSA | | | | TRF | | | | Trig | | | | TSH | | | | UA | | | | Vit B12 | | | | Vit D | | | | K | Refrigerated (2-8°C) | 3 days | | ALB | Refrigerated (2-8°C) | 7 days | | ALKP | | | | ALT | | | | AMY | | | | AST | | | | BUN | | | | Ca | | | | Chol | | | | CK | | | | CL | | | | Creat | | | | DBIL | | | | Fe | | | | GGT | | | K253539 - Page 20 of 41 {20} | Analyte | Temperature Condition | Storage Duration | | --- | --- | --- | | LDH | | | | Lip | | | | Mg | | | | Na | | | | Phos | | | | TBIL | | | | TP | | | | Trig | | | | UA | | | # b. Shelf-Life Real Time Shelf-life stability testing was conducted by using BD Vacutainer® Serum Plastic Blood Collection Tubes, BD Vacutainer® Serum Glass Blood Collection Tubes and BD Vacutainer® Rapid Serum Blood Collection Tube (RST). The results support the following shelf-life claims, when stored at 4-25°C (and 40°C for 15 days to simulate extreme temperatures during shipping): - BD Vacutainer® Serum Plastic Blood Collection Tubes for 16-24 months (depending on the tube model) - BD Vacutainer® Serum Glass Blood Collection Tubes for 24 months - BD Vacutainer® Rapid Serum Blood Collection Tube (RST) for 15 months. # c. Additional bench testing on the candidate device Benchtop studies were conducted to assess draw volume, X-value, 2nd stopper pullout, stopper/shield separation (on products with a Hemogard™ shield component), stopper leakage, tube leakage, breakage resistance during drop testing (on plastic tubes only) and breakage resistance during centrifugation testing. BD RST products, which contain a gel component, were also evaluated for barrier formation during centrifugation and for barrier integrity after simulated transport. Additionally, ship testing was conducted to assess the functional performance of the packaging materials. The study protocols were reviewed, and performance was considered acceptable. # 6. Assay Cut-Off: Not applicable. # B Comparison Studies: # 1. Method Comparison with Predicate Device: See Clinical Studies in section C.4 below. K253539 - Page 21 of 41 {21} 2. Matrix Comparison: Not applicable. # C Clinical Studies: 1. Clinical Sensitivity: Not applicable. 2. Clinical Specificity: Not applicable. 3. Clinical Cut-Off: Not applicable. 4. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable): Routine chemistry analytes A multi-part study was conducted to evaluate clinical equivalence between BD Vacutainer® Serum Plastic Tubes, BD Vacutainer® Serum Glass Tubes and BD Vacutainer® RST™ Blood Collection Tubes and cleared comparator serum separator tubes for testing representative analytes. A total of 180 participants were included in the study, with at least 100 patient samples within the measuring range of each assay tested. Blood was collected from each study participant using standard phlebotomy techniques. In addition, contrived samples were prepared to cover the clinically relevant range for the tested analytes. Samples were tested on two different instrument platforms (Beckman Coulter AU480 and Roche cobas® Integra 400 Plus). For each analyte and tube comparison, data was analyzed using Passing Bablok, Deming or Weighted Deming regression. Regression parameter estimates are provided in the tables below. Biases at important medical decision levels for each analyte between tube types were estimated with 95% confidence intervals and determined to be acceptable. Regression Parameter Estimates: BD Vacutainer® Serum Plastic Tubes vs. comparator tubes: | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Beckman Coulter AU480 | ALB (g/dL) | 1.04 (1, 1.09) | -0.18 (-0.42, 0) | 0.939 | PB | | Roche cobas® Integra 400 Plus | ALB (g/dL) | 0.99 (0.91, 1.07) | 0.02 (-0.33, 0.38) | 0.919 | WD | | Beckman Coulter AU480 | ALKP (U/L) | 1 (0.99, 1.02) | -0.42 (-1.71, 0.86) | 0.995 | WD | | Roche cobas® Integra 400 Plus | ALKP (U/L) | 0.99 (0.97, 1.02) | -0.19 (-2.41, 2.03) | 0.995 | WD | K253539 - Page 22 of 41 {22} | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Beckman Coulter AU480 | ALT (U/L) | 1.01(0.97, 1.05) | 0.5(-0.17, 1.17) | 0.998 | WD | | Roche cobas® Integra 400 Plus | ALT (U/L) | 1(0.98, 1.02) | -0.7(-1.2, -0.2) | 0.99 | PB | | Beckman Coulter AU480 | AMY (U/L) | 1.02(1, 1.05) | -1.14(-2.23, -0.04) | 0.988 | WD | | Roche cobas® Integra 400 Plus | AMY (U/L) | 1.01(0.99, 1.02) | -0.73(-1.53, 0.06) | 0.998 | WD | | Beckman Coulter AU480 | AST (U/L) | 1(1, 1.11) | 0(-1.67, 0) | 0.995 | PB | | Roche cobas® Integra 400 Plus | AST (U/L) | 1(0.94, 1.05) | -0.1(-1.28, 1.07) | 1 | WD | | Beckman Coulter AU480 | BUN(mg/dL) | 1(1, 1.03) | 0.2(-0.13, 0.3) | 0.998 | PB | | Roche cobas® Integra 400 Plus | BUN(mg/dL) | 1(0.99, 1.03) | 0.2(-0.16, 0.3) | 0.999 | PB | | Beckman Coulter AU480 | Ca (mg/dL) | 1.02(0.93, 1.1) | -0.18(-0.99, 0.63) | 0.972 | D | | Roche cobas® Integra 400 Plus | Ca (mg/dL) | 1(0.93, 1.06) | 0(-0.49, 0.64) | 0.96 | PB | | Beckman Coulter AU480 | Chol(mg/dL) | 1.05(0.99, 1.1) | -7.96(-17.68, 1.76) | 0.975 | WD | | Roche cobas® Integra 400 Plus | Chol(mg/dL) | 1.02(1, 1.05) | -5.41(-10.01, -0.81) | 0.991 | WD | | Beckman Coulter AU480 | CK (U/L) | 1.02(1, 1.04) | -0.19(-1.52, 1.15) | 0.998 | WD | | Roche cobas® Integra 400 Plus | CK (U/L) | 1(1, 1.01) | -0.33(-0.94, 0.28) | 1 | WD | | Beckman Coulter AU480 | CL(mmol/L) | 0.97(0.91, 1.03) | 3(-2.94, 8.94) | 0.937 | D | | Roche cobas® Integra 400 Plus | CL(mmol/L) | 0.9(0.79, 1) | 10.68(0.4, 22.12) | 0.873 | PB | | Beckman Coulter AU480 | CO2(mmol/L) | 0.94(0.86, 1.03) | 1.41(-0.63, 3.44) | 0.904 | WD | | Roche cobas® Integra 400 Plus | CO2(mmol/L) | 1.08(0.98, 1.18) | -1.49(-3.86, 0.89) | 0.878 | WD | | Beckman Coulter AU480 | Creat(mg/dL) | 1.03(1, 1.06) | -0.02(-0.04, 0) | 0.999 | WD | | Roche cobas® Integra 400 Plus | Creat(mg/dL) | 0.98(0.95, 1.02) | 0.03(0, 0.06) | 0.999 | WD | | Beckman Coulter AU480 | DBIL(mg/dL) | 0.98(0.81, 1.14) | -0.01(-0.02, 0.01) | 0.851 | D | K253539 - Page 23 of 41 {23} | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Roche cobas® Integra 400 Plus | DBIL (mg/dL) | 1.19(0.66, 1.72) | -0.01(-0.04, 0.02) | 0.816 | WD | | Beckman Coulter AU480 | Fe (mg/dL) | 1(1, 1.04) | -1(-2.79, 0) | 0.979 | PB | | Roche cobas® Integra 400 Plus | Fe (mg/dL) | 1.06(0.99, 1.14) | -4.07(-8.78, 0.64) | 0.995 | WD | | Beckman Coulter AU480 | GGT (U/L) | 0.99(0.97, 1.01) | -0.31(-0.85, 0.22) | 1 | WD | | Roche cobas® Integra 400 Plus | GGT (U/L) | 1(0.98, 1.01) | -0.05(-0.39, 0.28) | 1 | PB | | Beckman Coulter AU480 | GLUC (mg/dL) | 0.99(0.95, 1.03) | -1.25(-5.42, 2.92) | 0.993 | WD | | Roche cobas® Integra 400 Plus | GLUC (mg/dL) | 1.02(1, 1.06) | -3.36(-6.86, -1) | 0.997 | PB | | Beckman Coulter AU480 | HDL (mg/dL) | 1.03(0.99, 1.07) | -1.13(-2.58, 0.32) | 0.983 | WD | | Roche cobas® Integra 400 Plus | HDL (mg/dL) | 1(0.97, 1.03) | -0.37(-1.8, 1.06) | 0.971 | WD | | Beckman Coulter AU480 | LDH (U/L) | 1.08(0.98, 1.17) | -9.28(-19.91, 1.36) | 0.922 | WD | | Roche cobas® Integra 400 Plus | LDH (U/L) | 1.07(1.01, 1.14) | -9.27(-18.03, -0.51) | 0.904 | WD | | Beckman Coulter AU480 | LDL (mg/dL) | 1.03(1, 1.07) | -2.74(-6.98, 1.49) | 0.982 | WD | | Roche cobas® Integra 400 Plus | LDL (mg/dL) | 1.03(0.99, 1.06) | -2.43(-6.29, 1.43) | 0.992 | WD | | Beckman Coulter AU480 | Lip (U/L) | 0.99(0.96, 1.02) | -0.07(-0.53, 0.39) | 0.989 | WD | | Roche cobas® Integra 400 Plus | Lip (U/L) | 1(0.99, 1.01) | 0.04(-0.36, 0.44) | 0.999 | WD | | Beckman Coulter AU480 | Mg (mg/dL) | 1.01(0.95, 1.06) | -0.01(-0.11, 0.1) | 0.983 | D | | Roche cobas® Integra 400 Plus | Mg (mg/dL) | 1.01(0.97, 1.06) | -0.07(-0.17, 0.03) | 0.944 | D | | Beckman Coulter AU480 | Na (mmol/L) | 1.02(0.97, 1.06) | -1.87(-8.01, 4.28) | 0.939 | D | | Roche cobas® Integra 400 Plus | Na (mmol/L) | 0.97(0.83, 1.04) | 5.52(-4.22, 24.51) | 0.953 | PB | | Beckman Coulter AU480 | Phos (mg/dL) | 1.01(0.96, 1.05) | -0.19(-0.37, -0.01) | 0.968 | D | | Roche cobas® Integra 400 Plus | Phos (mg/dL) | 0.98(0.92, 1.04) | 0.08(-0.13, 0.28) | 0.983 | D | K253539 - Page 24 of 41 {24} | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Beckman Coulter AU480 | TBIL (mg/dL) | 1.01 (1, 1.01) | 0.01 (-0.01, 0.03) | 0.999 | D | | Roche cobas® Integra 400 Plus | TBIL (mg/dL) | 1.02 (1, 1.08) | 0 (-0.03, 0.01) | 0.999 | PB | | Beckman Coulter AU480 | TP (g/dL) | 1.02 (0.91, 1.13) | -0.14 (-0.89, 0.6) | 0.891 | WD | | Roche cobas® Integra 400 Plus | TP (g/dL) | 0.99 (0.93, 1.04) | 0.06 (-0.32, 0.45) | 0.948 | WD | | Beckman Coulter AU480 | Trig (mg/dL) | 0.99 (0.97, 1.01) | 0.4 (-2.01, 2.8) | 0.997 | WD | | Roche cobas® Integra 400 Plus | Trig (mg/dL) | 0.99 (0.98, 1) | -0.08 (-1.66, 1.5) | 0.999 | WD | | Beckman Coulter AU480 | UA (mg/dL) | 0.99 (0.96, 1.01) | -0.01 (-0.15, 0.14) | 0.99 | WD | | Roche cobas® Integra 400 Plus | UA (mg/dL) | 1 (0.99, 1.02) | 0.01 (-0.08, 0.1) | 0.995 | WD | PB = Passing Bablok, WD = Weighted Deming, D = Deming Regression Parameter Estimates: BD Vacutainer® Serum Glass Tubes vs. comparator tubes: | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Beckman Coulter AU480 | ALB (g/dL) | 1.02 (0.99, 1.05) | -0.07 (-0.22, 0.05) | 0.967 | PB | | Roche cobas® Integra 400 Plus | ALB (g/dL) | 1.01 (0.96, 1.07) | -0.05 (-0.28, 0.19) | 0.942 | WD | | Beckman Coulter AU480 | ALKP (U/L) | 1.02 (1, 1.05) | -1.04 (-2.73, 0.64) | 0.995 | WD | | Roche cobas® Integra 400 Plus | ALKP (U/L) | 1.01 (0.99, 1.02) | 0.04 (-1.02, 1.29) | 0.992 | PB | | Beckman Coulter AU480 | ALT (U/L) | 1.01 (0.97, 1.05) | 0.33 (-0.26, 0.92) | 0.998 | WD | | Roche cobas® Integra 400 Plus | ALT (U/L) | 1 (0.96, 1.04) | 0.22 (-0.37, 0.8) | 0.996 | WD | | Beckman Coulter AU480 | AMY (U/L) | 0.99 (0.96, 1.02) | -0.04 (-1.1, 1.03) | 0.991 | WD | | Roche cobas® Integra 400 Plus | AMY (U/L) | 1 (0.99, 1.01) | 0.04 (-0.41, 0.5) | 0.999 | WD | | Beckman Coulter AU480 | AST (U/L) | 1.03 (0.99, 1.06) | -0.37 (-0.98, 0.25) | 0.999 | WD | | Roche cobas® Integra 400 Plus | AST (U/L) | 1 (0.96, 1.04) | 0.14 (-0.68, 0.96) | 1 | WD | | Beckman Coulter AU480 | BUN (mg/dL) | 1 (1, 1.02) | 0.1 (-0.12, 0.2) | 0.999 | PB | K253539 - Page 25 of 41 {25} | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Roche cobas® Integra 400 Plus | BUN (mg/dL) | 1(0.98, 1.01) | 0.1(-0.09, 0.33) | 0.998 | PB | | Beckman Coulter AU480 | Ca (mg/dL) | 1.04(1.01, 1.08) | -0.49(-0.86, -0.11) | 0.963 | D | | Roche cobas® Integra 400 Plus | Ca (mg/dL) | 0.96(0.87, 1) | 0.33(-0.1, 1.26) | 0.939 | PB | | Beckman Coulter AU480 | Chol (mg/dL) | 1(0.97, 1.03) | 0.89(-5.15, 6.93) | 0.987 | WD | | Roche cobas® Integra 400 Plus | Chol (mg/dL) | 1.01(0.99, 1.03) | -0.69(-4, 2.62) | 0.991 | WD | | Beckman Coulter AU480 | CK (U/L) | 1.01(1, 1.02) | 0.09(-1.11, 1.29) | 0.999 | WD | | Roche cobas® Integra 400 Plus | CK (U/L) | 1(1, 1.01) | -0.06(-0.86, 0.73) | 1 | WD | | Beckman Coulter AU480 | CL (mmol/L) | 0.97(0.93, 1.02) | 2.33(-2.13, 6.79) | 0.935 | D | | Roche cobas® Integra 400 Plus | CL (mmol/L) | 1(0.94, 1.06) | 0.1(-5.94, 6.12) | 0.943 | PB | | Beckman Coulter AU480 | CO2(mmol/L) | 0.94(0.88, 1.01) | 0.76(-0.91, 2.43) | 0.925 | WD | | Roche cobas® Integra 400 Plus | CO2(mmol/L) | 0.93(0.86, 0.99) | 1.12(-0.4, 2.65) | 0.947 | WD | | Beckman Coulter AU480 | Creat (mg/dL) | 1.03(1, 1.05) | -0.02(-0.04, 0) | 0.999 | WD | | Roche cobas® Integra 400 Plus | Creat (mg/dL) | 1.01(0.99, 1.04) | -0.01(-0.03, 0.01) | 0.999 | WD | | Beckman Coulter AU480 | DBIL (mg/dL) | 1.04(1, 1.08) | 0(0, 0.01) | 0.965 | D | | Roche cobas® Integra 400 Plus | DBIL (mg/dL) | 0.75(0.57, 0.93) | 0.01(0, 0.02) | 0.877 | WD | | Beckman Coulter AU480 | Fe (mg/dL) | 1(0.98, 1.03) | 0.16(-1.28, 1.6) | 0.994 | WD | | Roche cobas® Integra 400 Plus | Fe (mg/dL) | 1.02(1, 1.04) | -0.71(-1.94, 0.52) | 0.993 | WD | | Beckman Coulter AU480 | GGT (U/L) | 1(0.98, 1.02) | -0.23(-0.77, 0.31) | 1 | WD | | Roche cobas® Integra 400 Plus | GGT (U/L) | 1.01(1, 1.02) | -0.25(-0.53, 0.1) | 1 | PB | | Beckman Coulter AU480 | GLUC (mg/dL) | 0.99(0.96, 1) | -1.04(-3, 1.98) | 0.989 | PB | | Roche cobas® Integra 400 Plus | GLUC (mg/dL) | 1.01(0.99, 1.03) | -3.43(-6.02, -0.84) | 0.997 | WD | | Beckman Coulter AU480 | HDL (mg/dL) | 1.04(1, 1.09) | -0.65(-2.44, 1.13) | 0.989 | WD | K253539 - Page 26 of 41 {26} | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Roche cobas® Integra 400 Plus | HDL (mg/dL) | 1 (0.96, 1.03) | -0.04 (-1.5, 1.43) | 0.976 | WD | | Beckman Coulter AU480 | LDH (U/L) | 1.01 (0.92, 1.09) | -2.65 (-13.11, 7.81) | 0.933 | WD | | Roche cobas® Integra 400 Plus | LDH (U/L) | 1.03 (0.99, 1.07) | -3.6 (-9.71, 2.51) | 0.973 | WD | | Beckman Coulter AU480 | LDL (mg/dL) | 1 (0.99, 1.02) | 1 (-1.56, 2.28) | 0.983 | PB | | Roche cobas® Integra 400 Plus | LDL (mg/dL) | 1 (0.97, 1.02) | 0.7 (-2.27, 3.67) | 0.995 | WD | | Beckman Coulter AU480 | Lip (U/L) | 1.01 (0.97, 1.06) | -0.56 (-1.77, 0.65) | 0.995 | WD | | Roche cobas® Integra 400 Plus | Lip (U/L) | 1.01 (0.99, 1.02) | -0.22 (-0.6, 0.16) | 0.998 | WD | | Beckman Coulter AU480 | Mg (mg/dL) | 1.01 (0.97, 1.04) | -0.01 (-0.08, 0.07) | 0.987 | D | | Roche cobas® Integra 400 Plus | Mg (mg/dL) | 1.04 (1, 1.08) | -0.14 (-0.23, -0.05) | 0.959 | D | | Beckman Coulter AU480 | Na (mmol/L) | 0.98 (0.93, 1.02) | 3.12 (-2.48, 8.72) | 0.969 | D | | Roche cobas® Integra 400 Plus | Na (mmol/L) | 0.98 (0.88, 1) | 2.92 (-0.53, 16.49) | 0.991 | PB | | Beckman Coulter AU480 | Phos (mg/dL) | 1 (1, 1.06) | -0.1 (-0.3, -0.1) | 0.925 | PB | | Roche cobas® Integra 400 Plus | Phos (mg/dL) | 1 (1, 1) | -0.1 (-0.1, 0) | 0.97 | PB | | Beckman Coulter AU480 | TBIL (mg/dL) | 1.01 (1, 1.02) | -0.01 (-0.02, 0) | 1 | D | | Roche cobas® Integra 400 Plus | TBIL (mg/dL) | 1.02 (1, 1.05) | 0 (-0.01, 0.02) | 0.999 | PB | | Beckman Coulter AU480 | TP (g/dL) | 0.99 (0.89, 1.09) | 0.09 (-0.61, 0.8) | 0.892 | WD | | Roche cobas® Integra 400 Plus | TP (g/dL) | 1 (0.94, 1.06) | 0.01 (-0.41, 0.42) | 0.958 | WD | | Beckman Coulter AU480 | Trig (mg/dL) | 1 (0.99, 1.02) | -0.04 (-1.91, 1.82) | 0.998 | WD | | Roche cobas® Integra 400 Plus | Trig (mg/dL) | 1 (0.99, 1.01) | 0 (-1.06, 1.57) | 0.995 | PB | | Beckman Coulter AU480 | UA (mg/dL) | 0.98 (0.96, 1) | 0.04 (-0.04, 0.13) | 0.991 | WD | | Roche cobas® Integra 400 Plus | UA (mg/dL) | 1.02 (0.99, 1.04) | -0.09 (-0.19, 0.02) | 0.992 | WD | K253539 - Page 27 of 41 {27} Regression Parameter Estimates: BD Vacutainer® RST™ vs. comparator tubes: | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Beckman Coulter AU480 | ALB (g/dL) | 0.96 (0.91, 1) | 0.16 (-0.02, 0.33) | 0.957 | WD | | Roche cobas® Integra 400 Plus | ALB (g/dL) | 0.99 (0.94, 1.05) | -0.01 (-0.24, 0.23) | 0.926 | WD | | Beckman Coulter AU480 | ALKP (U/L) | 1 (0.99, 1.02) | -0.13 (-1.11, 0.85) | 0.993 | WD | | Roche cobas® Integra 400 Plus | ALKP (U/L) | 1.01 (0.98, 1.03) | -1.04 (-3.58, 1.5) | 0.997 | WD | | Beckman Coulter AU480 | ALT (U/L) | 0.98 (0.94, 1.01) | 0.07 (-0.65, 0.8) | 0.998 | WD | | Roche cobas® Integra 400 Plus | ALT (U/L) | 0.99 (0.97, 1.01) | 0.05 (-0.38, 0.46) | 0.997 | PB | | Beckman Coulter AU480 | AMY (U/L) | 1 (0.98, 1.03) | -0.96 (-1.94, 0.01) | 0.99 | WD | | Roche cobas® Integra 400 Plus | AMY (U/L) | 1 (0.99, 1.01) | -0.25 (-0.73, 0.23) | 0.999 | WD | | Beckman Coulter AU480 | AST (U/L) | 1.05 (0.99, 1.11) | -0.99 (-1.78, -0.19) | 0.999 | WD | | Roche cobas® Integra 400 Plus | AST (U/L) | 0.99 (0.94, 1.03) | 0.21 (-0.7, 1.13) | 1 | WD | | Beckman Coulter AU480 | BUN (mg/dL) | 1 (0.99, 1.01) | 0 (-0.11, 0.17) | 0.999 | PB | | Roche cobas® Integra 400 Plus | BUN (mg/dL) | 1.01 (1, 1.03) | 0.04 (-0.32, 0.2) | 0.999 | PB | | Beckman Coulter AU480 | Ca (mg/dL) | 0.99 (0.9, 1.09) | 0.11 (-0.79, 1) | 0.986 | WD | | Roche cobas® Integra 400 Plus | Ca (mg/dL) | 0.95 (0.93, 0.98) | 0.48 (0.23, 0.74) | 0.97 | WD | K253539 - Page 28 of 41 {28} | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Beckman Coulter AU480 | Chol (mg/dL) | 1 (0.97, 1.03) | -0.28 (-6.41, 5.84) | 0.988 | D | | Roche cobas® Integra 400 Plus | Chol (mg/dL) | 1 (0.98, 1.02) | -1.01 (-5.06, 3.04) | 0.994 | D | | Beckman Coulter AU480 | CK (mg/dL) | 1 (0.99, 1.01) | 0.92 (0.05, 1.79) | 0.999 | WD | | Roche cobas® Integra 400 Plus | CK (mg/dL) | 0.99 (0.99, 1) | 0.19 (-0.52, 0.91) | 1 | PB | | Beckman Coulter AU480 | CL (mmol/L) | 1.01 (0.98, 1.03) | -0.31 (-3.13, 2.51) | 0.961 | D | | Roche cobas® Integra 400 Plus | CL (mmol/L) | 0.98 (0.9, 1.06) | 2.73 (-5.06, 10.52) | 0.936 | D | | Beckman Coulter AU480 | CO₂ (mmol/L) | 0.98 (0.91, 1.06) | 0.55 (-1.32, 2.43) | 0.94 | WD | | Roche cobas® Integra 400 Plus | CO₂ (mmol/L) | 1.04 (0.98, 1.14) | -0.69 (-2.99, 0.72) | 0.92 | WD | | Beckman Coulter AU480 | Creat (mg/dL) | 1 (0.98, 1) | 0 (0, 0.02) | 0.999 | PB | | Roche cobas® Integra 400 Plus | Creat (mg/dL) | 1.01 (0.98, 1.03) | 0 (-0.02, 0.02) | 0.999 | WD | | Beckman Coulter AU480 | DBIL (mg/dL) | 1 (0.93, 1.07) | 0 (-0.01, 0.01) | 0.965 | D | | Roche cobas® Integra 400 Plus | DBIL (mg/dL) | 0.98 (0.59, 1.38) | 0 (-0.02, 0.03) | 0.88 | WD | | Beckman Coulter AU480 | Fe (μg/dL) | 0.98 (0.96, 1) | 0.08 (-1.2, 1.36) | 0.997 | WD | | Roche cobas® Integra 400 Plus | Fe (μg/dL) | 1.06 (1.02, 1.1) | -4.21 (-6.62, -1.81) | 0.997 | WD | | Beckman Coulter AU480 | GGT (U/L) | 1 (0.98, 1.03) | -0.11 (-0.7, 0.47) | 1 | WD | K253539 - Page 29 of 41 {29} | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Roche cobas® Integra 400 Plus | GGT (U/L) | 0.99 (0.99, 1) | -0.17 (-0.4, 0.02) | 1 | PB | | Beckman Coulter AU480 | GLUC (mg/dL) | 1.02 (0.97, 1.06) | 0.55 (-3.46, 4.57) | 0.991 | WD | | Roche cobas® Integra 400 Plus | GLUC (mg/dL) | 1.03 (1.01, 1.06) | 0.4 (-2.04, 2.84) | 0.998 | WD | | Beckman Coulter AU480 | HDL (mg/dL) | 0.98 (0.95, 1.01) | 0.27 (-1.05, 1.59) | 0.995 | WD | | Roche cobas® Integra 400 Plus | HDL (mg/dL) | 0.98 (0.95, 1.01) | 0.18 (-0.96, 1.31) | 0.983 | WD | | Beckman Coulter AU480 | K (mmol/L) | 1 (0.91, 1.09) | 0.1 (-0.24, 0.45) | 0.757 | PB | | Roche cobas® Integra 400 Plus | K (mmol/L) | 0.99 (0.89, 1.09) | 0.12 (-0.3, 0.54) | 0.832 | D | | Beckman Coulter AU480 | LDH (U/L) | 1.06 (1.02, 1.1) | -10.5 (-17.55, -4.84) | 0.954 | PB | | Roche cobas® Integra 400 Plus | LDH (U/L) | 1 (0.96, 1.03) | -1.34 (-6.38, 3.69) | 0.957 | WD | | Beckman Coulter AU480 | LDL (mg/dL) | 1.01 (0.98, 1.05) | -2.05 (-5.94, 1.83) | 0.984 | WD | | Roche cobas® Integra 400 Plus | LDL (mg/dL) | 1.01 (0.99, 1.03) | -1.29 (-3.79, 1.21) | 0.995 | WD | | Beckman Coulter AU480 | Lip (U/L) | 0.99 (0.96, 1.01) | -0.09 (-0.57, 0.39) | 0.991 | WD | | Roche cobas® Integra 400 Plus | Lip (U/L) | 1 (0.99, 1.01) | -0.09 (-0.36, 0.18) | 0.999 | WD | | Beckman Coulter AU480 | Mg (mg/dL) | 1 (0.98, 1.01) | -0.05 (-0.09, -0.02) | 0.994 | D | | Roche cobas® Integra 400 Plus | Mg (mg/dL) | 0.99 (0.93, 1.06) | -0.04 (-0.18, 0.09) | 0.938 | D | K253539 - Page 30 of 41 {30} | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Beckman Coulter AU480 | Na (mmol/L) | 1 (0.98, 1.03) | -0.15 (-3.5, 3.2) | 0.973 | D | | Roche cobas® Integra 400 Plus | Na (mmol/L) | 0.98 (0.98, 0.99) | 2.66 (1.2, 4.13) | 0.991 | D | | Beckman Coulter AU480 | Phos (mg/dL) | 1.02 (0.97, 1.06) | -0.13 (-0.28, 0.03) | 0.972 | D | | Roche cobas® Integra 400 Plus | Phos (mg/dL) | 0.98 (0.96, 1.01) | 0.11 (0.03, 0.2) | 0.987 | D | | Beckman Coulter AU480 | TBIL (mg/dL) | 1.02 (1.01, 1.03) | -0.02 (-0.03, 0) | 0.999 | D | | Roche cobas® Integra 400 Plus | TBIL (mg/dL) | 1 (0.99, 1.03) | 0 (-0.01, 0.01) | 0.999 | PB | | Beckman Coulter AU480 | TP (g/dL) | 0.98 (0.9, 1.05) | 0.23 (-0.32, 0.78) | 0.933 | WD | | Roche cobas® Integra 400 Plus | TP (g/dL) | 0.93 (0.89, 0.98) | 0.49 (0.15, 0.84) | 0.954 | WD | | Beckman Coulter AU480 | Trig (mg/dL) | 0.99 (0.98, 1) | 0.91 (-0.66, 2.49) | 0.999 | WD | | Roche cobas® Integra 400 Plus | Trig (mg/dL) | 0.99 (0.98, 1.01) | 0.66 (-1.34, 2.65) | 0.998 | WD | | Beckman Coulter AU480 | UA (mg/dL) | 0.99 (0.98, 1.01) | 0.03 (-0.02, 0.09) | 0.996 | WD | | Roche cobas® Integra 400 Plus | UA (mg/dL) | 1 (0.98, 1.02) | 0.03 (-0.06, 0.12) | 0.994 | WD | # Special Chemistry Analytes and Cardiac Markers A multi-part study was conducted to evaluate equivalence between: a) BD Vacutainer® Serum Plastic tubes vs. cleared serum separator tubes; b) BD Vacutainer® Serum Glass tubes vs. cleared serum separator tubes and c) BD Vacutainer® RST™ Blood Collection Tubes vs. cleared serum separator tubes for testing special chemistry analytes and cardiac markers. A total of 180 participants were included in the study. Blood was collected from each study participant using standard phlebotomy techniques. In addition, contrived samples were prepared to cover the clinically relevant range for the tested analytes. Samples were tested on two different instrument platforms for each analyte. K253539 - Page 31 of 41 {31} For each analyte and tube comparison, data was analyzed using Passing Bablok regression, Deming or Weighted Deming regression. Regression parameter estimates are provided in the tables below. Biases at important medical decision levels for each analyte between tube types were estimated with 95% confidence intervals and determined to be acceptable. Regression Parameter Estimates: BD Vacutainer® Serum Plastic Tubes vs. comparator tubes: | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Beckman DxC 700 AU | C3 (mg/dL) | 0.97 (0.95, 1) | -0.37 (-3.82, 3.08) | 0.99 | WD | | OCD Vitros 5600 | C3 (mg/dL) | 0.95 (0.92, 0.98) | 2.88 (-0.45, 6.4) | 0.984 | PB | | Beckman DxC 700 AU | CKMB (U/L) | 1.04 (0.98, 1.11) | 0.39 (-0.78, 1.56) | 0.98 | WD | | Roche Cobas e411 | CKMB (ng/mL) | 1.03 (1.01, 1.05) | -0.04 (-0.08, 0.01) | 0.999 | WD | | OCD Vitros 5600 | CORT (nmol/L) | 0.99 (0.98, 1) | 0.73 (-0.23, 1.69) | 0.998 | WD | | Roche Cobas e411 | CORT (nmol/L) | 0.99 (0.98, 1.01) | -1.12 (-3.02, 0.65) | 0.997 | PB | | Beckman DxC 700 AU | CRP (mg/L) | 1 (1, 1.01) | -0.01 (-0.03, 0.01) | 0.997 | PB | | OCD Vitros 5600 | CRP (mg/dL) | 0.99 (0.98, 1) | -0.09 (-0.2, -0.08) | 0.954 | PB | | OCD Vitros 3600/5600 | E2 (pmol/L) | 1.05 (1.03, 1.07) | 1.64 (-0.98, 5.25) | 0.999 | PB | | Siemens Dimension Vista 1500 | E2 (pg/mL) | 1.01 (0.99, 1.02) | -0.2 (-1.69, 1.3) | 0.998 | PB | | OCD Vitros 3600/5600 | FERR (ng/mL) | 0.96 (0.95, 0.97) | 0.13 (-0.05, 0.31) | 0.999 | WD | | Siemens Dimension Vista 1500 | FERR (ng/mL) | 1 (0.99, 1.01) | 0.03 (-0.2, 0.25) | 0.999 | WD | | OCD Vitros 3600/5600 | FOLATE (ng/mL) | 0.97 (0.92, 1.03) | 0.23 (-0.25, 0.7) | 0.956 | PB | | Siemens Dimension Vista 1500 | FOLATE (ng/mL) | 1.01 (0.99, 1.04) | 0.04 (-0.31, 0.38) | 0.988 | PB | | OCD Vitros 3600/5600 | FSH (mIU/mL) | 0.96 (0.95, 0.97) | -0.04 (-0.08, 0.01) | 0.999 | WD | | Siemens Dimension Vista 1500 | FSH (mIU/mL) | 1 (1, 1.01) | 0.04 (0, 0.09) | 1 | WD | K253539 - Page 32 of 41 {32} | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Integra 400 Plus | HAPTO (g/L) | 1 (0.99, 1.02) | 1.97 (-0.33, 4.28) | 0.997 | WD | | OCD Vitros 5600 | HAPTO (mg/dL) | 1 (0.98, 1.02) | 0.26 (-2.76, 3.27) | 0.995 | WD | | OCD Vitros 3600/5600 | HCG (mIU/mL) | 1 (0.99, 1) | 0.08 (0.01, 0.15) | 1 | WD | | Siemens Dimension Vista 1500 | HCG (mIU/mL) | 1.01 (1, 1.01) | 0.05 (-0.05, 0.14) | 0.999 | WD | | Beckman DxC 700 AU | IgA (mg/dL) | 0.99 (0.98, 1) | 0.72 (-0.25, 1.7) | 0.999 | WD | | OCD Vitros 5600 | IgA (mg/dL) | 0.98 (0.97, 0.99) | 0.47 (-1.09, 2.03) | 0.999 | WD | | Beckman DxC 700 AU | IgG (mg/dL) | 0.97 (0.96, 0.99) | 21.32 (8.38, 34.27) | 0.996 | WD | | OCD Vitros 5600 | IgG (mg/dL) | 0.99 (0.96, 1.01) | 9.13 (-12.35, 30.6) | 0.994 | WD | | Beckman DxC 700 AU | IgM (mg/dL) | 1 (0.98, 1.01) | -0.36 (-1.17, 0.46) | 0.999 | WD | | OCD Vitros 5600 | IgM (mg/dL) | 1 (0.99, 1.01) | -1.22 (-2.3, -0.13) | 1 | WD | | OCD Vitros 3600/5600 | LH (mIU/mL) | 0.96 (0.95, 0.97) | -0.02 (-0.07, 0.04) | 0.999 | PB | | Siemens Dimension Vista 1500 | LH (mIU/mL) | 1 (1, 1.01) | 0 (-0.04, 0.1) | 0.999 | PB | | OCD Vitros 5600 | NT-proBNP (pg/mL) | 0.99 (0.97, 1.01) | 0.46 (-0.82, 1.74) | 0.999 | WD | | Roche Cobas e411 | NT-proBNP (pg/mL) | 1.01 (1, 1.02) | -0.14 (-2.93, 2.66) | 1 | WD | | OCD Vitros 3600/5600 | PROG (nmol/L) | 1 (0.99, 1.02) | -0.06 (-0.1, -0.03) | 1 | PB | | Siemens Dimension Vista 1500 | PROG (ng/mL) | 1.02 (1.01, 1.03) | -0.01 (-0.02, 0) | 1 | PB | | OCD Vitros 5600 | TPSA (ng/mL) | 0.99 (0.98, 1) | 0 (0, 0.01) | 0.988 | PB | | Roche Cobas e411 | TPSA (ng/mL) | 1 (0.99, 1.01) | 0 (0, 0.01) | 1 | PB | | Beckman DxC 700 AU | RF (IU/mL) | 1.02 (1, 1.04) | -0.41 (-0.76, -0.07) | 0.998 | WD | | OCD Vitros 5600 | RF (IU/mL) | 0.99 (0.98, 1.01) | -0.14 (-0.66, 0.38) | 0.999 | WD | K253539 - Page 33 of 41 {33} | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Beckman Access2 | Total T3 (ng/mL) | 1 (0.95, 1.06) | -0.01 (-0.04, 0.03) | 0.978 | WD | | Roche Cobas e411 | Total T3 (nmol/L) | 0.99 (0.95, 1.02) | -0.02 (-0.06, 0.03) | 0.965 | WD | | OCD Vitros 3600/5600 | Free T3 (pmol/L) | 0.98 (0.92, 1.04) | -0.07 (-0.38, 0.28) | 0.942 | PB | | Siemens Dimension Vista 1500 | Free T3 (pg/mL) | 1.02 (0.98, 1.06) | -0.06 (-0.15, 0.04) | 0.99 | WD | | OCD Vitros 3600/5600 | Total T4 (nmol/L) | 0.99 (0.97, 1.01) | 1.05 (-1.29, 3.38) | 0.992 | WD | | Siemens Dimension Vista 1500 | Total T4 (μg/dL) | 1 (0.97, 1.06) | -0.1 (-0.68, 0.11) | 0.97 | PB | | Beckman Access2 | Free T4 (ng/dL) | 1 (0.96, 1.03) | -0.01 (-0.04, 0.02) | 0.982 | WD | | Roche Cobas e411 | Free T4 (ng/dL) | 0.99 (0.97, 1.01) | 0 (-0.02, 0.03) | 0.995 | WD | | OCD Vitros 5600 | TESTO (nmol/L) | 1.06 (1.04, 1.07) | 0.01 (-0.02, 0.02) | 0.997 | PB | | Roche Cobas e411 | TESTO (ng/mL) | 1 (0.99, 1.01) | 0 (-0.01, 0.01) | 0.999 | PB | | Integra 400 Plus | TRF (mg/L) | 1 (0.97, 1.04) | 4.32 (-3.92, 12.55) | 0.987 | WD | | OCD Vitros 5600 | TRF (mg/dL) | 1.02 (1, 1.04) | -3.62 (-8.27, 1.02) | 0.997 | WD | | OCD Vitros 3600/5600 | TSH (μIU/mL) | 1 (0.98, 1.01) | 0 (-0.01, 0.01) | 1 | PB | | Siemens Dimension Vista 1500 | TSH (μIU/mL) | 1.01 (1, 1.02) | 0 (-0.02, 0.01) | 1 | PB | | Beckman Access2 | TnI (ng/mL) | 1.04 (1.01, 1.05) | 0 (0, 0.01) | 0.997 | PB | | Roche Cobas e411 | TnI (ng/mL) | 1.31 (1.18, 1.43) | -0.05 (-0.1, 0.01) | 0.984 | WD | | Roche Cobas e411/e601 | TnT (ng/mL) | 1.05 (1.01, 1.08) | -0.29 (-1.03, 0.44) | 0.998 | WD | | OCD Vitros 3600/5600 | Vit B12 (pg/mL) | 1.07 (1.02, 1.12) | -9.17 (-21.95, 3.61) | 0.97 | WD | | Siemens Dimension Vista 1500 | Vit B12 (pg/mL) | 1 (0.98, 1.02) | 3.61 (-4.17, 1.39) | 0.998 | WD | | Beckman Access2 | Vit D (ng/mL) | 1.02 (0.99, 1.05) | -0.48 (-1.11, 0.16) | 0.995 | WD | K253539 - Page 34 of 41 {34} | Instrument | Analyte (unit) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient | Regression | | --- | --- | --- | --- | --- | --- | | Roche Cobas e411 | Vit D (ng/mL) | 0.98 (0.94, 1.01) | -0.28 (-0.96, 0.41) | 0.99 | WD | | ADVIA Centaur XPT | hsTnI (pg/mL) | 1.04 (1, 1.07) | -0.15 (-0.38, 0.08) | 0.998…