Tina-quant Transferrin ver.2 (urine application)

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November 5, 2018 Roche Diagnostics Operations (RDO) Lindsay Jones Regulatory Affairs Consultant 9115 Hague Road Indianapolis, Indiana 46250 Re: K182095 Trade/Device Name: Tina-quant Transferrin ver.2 (urine application) Regulation Number: 21 CFR 866.5880 Regulation Name: Transferrin immunological test system Regulatory Class: Class II Product Code: DDG Dated: August 1, 2018 Received: August 3, 2018 Dear Lindsay Jones: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. 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For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Leonthena R. Carrington -S Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K182095 Device Name Tina-quant Transferrin ver.2 (urine application) Indications for Use (Describe) Tina-quant Transferrin ver.2 (urine application) assay is an in vitro test for the quantitative determination of transferrin in human urine on Roche/Hitachi cobas c systems. A transferin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in urine. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Tina-quant Transferrin ver.2 (urine application) 510(k) Summary (K182095) This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k). The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the Tina-quant Transferrin ver.2 (urine application). | Submitter Name | Roche Diagnostics Operations (RDO) | | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Address | 9115 Hague Road<br>Indianapolis, IN 46250, USA | | | Contact | Lindsay Jones<br>Phone: (317) 521-3544<br>FAX: (317) 521-2324<br>Email: lindsay.jones.lj1 @roche.com | | | Date Prepared | November 1, 2018 | | | Proprietary Name | Tina-quant Transferrin ver.2 (urine application) | | | Common Name | Transferrin | | | Classification Name | Transferrin immunological test system, Class II | | | Product Codes,<br>Regulation Numbers | DDG, 21 CFR § 866.5880 | | | Predicate Devices | N Antisera to Human Transferrin (K053075) | | | Establishment Registration | For the Tina-quant Transferrin ver.2 (urine application), the establishment<br>registration number for Roche Diagnostics GmbH in Mannheim, Germany is<br>9610126. | | {4}------------------------------------------------ #### DEVICE DESCRIPTION 1. The Tina-quant Transferrin ver.2 (urine application) assay is a two reagent assay for the in vitro quantitative determination of transferrin in human urine on automated clinical chemistry analyzers. It is an immunoturbidimetric assay in which human transferrin forms a precipitate with a specific antiserum which is determined turbidimetrically. Engineering drawings, schematics, and figures are not pertinent to describe the device, as the device is a reagent. #### INDICATIONS FOR USE 2. Tina-quant Transferrin ver.2 (urine application) assay is an in vitro test for the quantitative determination of transferrin in human urine on Roche/Hitachi cobas c systems. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in urine. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. #### TECHNOLOGICAL CHARACTERISTICS 3. The Roche transferrin assay is based on the immunological agglutination principle. Human transferrin forms a precipitate with a specific antiserum which is determined turbidimetrically. The following table compares the Tina-quant Transferrin ver.2 (urine application) with its predicate device, N Antisera to Human Transferrin (K053075). See Table 1 below. {5}------------------------------------------------ | Feature | Predicate Device<br>N Antisera to Human Transferrin<br>(K053075) | Candidate Device<br>Tina-quant Transferrin ver.2<br>(urine application) | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | In vitro diagnostic reagents for the<br>quantitative determination of transferrin and<br>haptoglobin in human serum, heparinized<br>and EDTA plasma, as well as transferrin in<br>human urine by means of<br>immunonephelometry on the BN II and BN™<br>ProSpec System. | In vitro test for the quantitative<br>determination of transferrin in<br>human urine on Roche/Hitachi<br>cobas c systems. | | Test Principle | Proteins contained in human body fluids<br>form immune complexes in an<br>immunochemical reaction with specific<br>antibodies. These complexes scatter a beam<br>of light passed through the sample. The<br>intensity of the scattered light is proportional<br>to the concentration of the relevant protein in<br>the sample. The result is evaluated by<br>comparison with a standard of known<br>concentration. | Human transferrin forms a<br>precipitate with a specific<br>antiserum which is determined<br>turbidimetrically. | | Instrument | BN II/BN ProSpec System | cobas c 501 | | Reagent Composition | N Antisera are liquid animal sera and are<br>produced by immunization of rabbits with<br>highly purified human transferrin. The<br>concentration of active antibodies is < 4.2<br>g/L to human transferrin.<br>Preservative<br>Sodium azide <1 g/L | R1: Phosphate buffer: 55<br>mmol/L, pH 7.2; NaCl: 25<br>mmol/L; polyethylene glycol: 5 %;<br>preservative<br>R2: Anti-human transferrin<br>antibodies (rabbit): dependent on<br>titer; NaCl: 100 mmol/L;<br>preservative | | Sample Type/Matrix | Serum, heparinized and EDTA plasma, urine | Urine | | Calibrator | N Protein Standard SL | S1: H2O<br>S2 - S6: Calibrator for<br>automated systems (C.f.a.s.)<br>Proteins (K133330) | | Calibration Interval | The reference curves can be used for as<br>long as controls with corresponding method-<br>depending target values, e.g. N/T Protein<br>Controls SL/L, M and H or N/T Protein<br>Control LC, are reproduced within their<br>respective range. If a different lot of<br>antiserum is used, a new reference curved<br>must be generated. | Full calibration:<br>• after reagent lot change<br>• as required following<br>quality control<br>procedures | | Feature | Predicate Device<br>N Antisera to Human Transferrin<br>(K053075) | Candidate Device<br>Tina-quant Transferrin ver.2<br>(urine application) | | Controls | Serum/plasma: N/T Protein Controls SL/L,<br>M, and H<br>Urine: N/T Protein Control LC | PreciControl ClinChem Multi 1 &<br>PreciControl ClinChem Multi 2<br>(K133330)<br>Precinorm Protein & Precipath<br>Protein (K133330) | | Reagent Shelf-Life Stability | Stability at 2 - 8 °C: See expiry date on<br>label.<br>Stability once opened: 4 weeks if stored at 2 | | | | – 8 °C securely capped immediately after<br>each use and contamination (e.g., by<br>microorganisms) is precluded. During<br>storage, N Antisera can develop precipitates<br>or turbidity which are not caused by<br>microbial contamination and which do not<br>affect their activity. In such cases, the<br>antiserum should be filtered prior to use.<br>Disposable filters with a pore size of 0.45 µm<br>are suitable for this purpose. Do not freeze. | Shelf life at 2 - 8 °C: See<br>expiration date on cobas c pack<br>label. | | Reagent On-Board Stability | A minimum of 5 days at 8 hours per day for 5<br>mL vials, and 3 days at 8 hours per day for 2<br>mL vials or a comparable period of time. | On-board in use and refrigerated<br>on the analyzer: 8 weeks | | Measuring Range | Serum/plasma: 35.0 to 560 mg/dL<br>Urine: 0.22 to 3.5 mg/dL | 0.22 to 3.5 mg/dL | | Reference Range | Reference interval for urinary transferrin: the<br>concentration of transferrin in the urine of<br>healthy individuals is below the detection<br>limit of this method.<br>Nevertheless, each laboratory should<br>determine its own reference intervals since<br>values may vary depending on the individual<br>population studied.<br>Siemens has not established reference<br>ranges for children. | ≤ 1.9 mg/L* (0.19 mg/dL)<br>* The concentration of transferrin<br>in urine of healthy individuals is<br>below the detection limit of this<br>method.<br>Each laboratory should<br>investigate the transferability of<br>the expected values to its own<br>patient population and if<br>necessary determine its own<br>reference ranges. | | Feature | Predicate Device<br>N Antisera to Human Transferrin<br>(K053075) | Candidate Device<br>Tina-quant Transferrin ver.2<br>(urine application) | | Sample Stability | Suitable samples are human serum,<br>heparinized or EDTA plasma as fresh as<br>possible (stored no more than 7 days at 2 –<br>8 °C), or stored frozen and fresh human<br>urine. Serum and plasma samples can be<br>stored at below – 20 °C for up to 3 months if<br>they are frozen within 24 hours after<br>collection and if repeated freeze thaw cycles<br>are avoided. Serum samples must be<br>completely coagulated and, after<br>centrifugation, must not contain any particles<br>or traces of fibrin. Lipemic samples or frozen<br>samples that are turbid after thawing must<br>be clarified by centrifugation (10 minutes at<br>approximately 15,000 x g) prior to testing.<br>Random and timed urine collections are<br>suitable specimens for testing transferrin in<br>urine. Urine samples must not be frozen.<br>Each urine samples must be centrifuged<br>prior to testing. | 4 days at 15 – 25 °C<br>7 days at 2 – 8 °C<br>Freezing and thawing is not<br>allowed | #### Table 1: Assay Comparison {6}------------------------------------------------ {7}------------------------------------------------ #### NON-CLINICAL PERFORMANCE EVALUATION 4. The following performance data were provided in support of the substantial equivalence determination: Precision according to CLSI EP05-A3 Detection Limit: LoB, LoD, LoQ according to CLSI EP17-A2 Linearity according to CLSI EP06-A Endogenous Interferences Exogenous Interferences – Drugs Method Comparison to Predicate All performance specifications were met. {8}------------------------------------------------ #### 4.1. Precision #### Repeatability and Intermediate Precision 4.1.1. Precision experiments were performed in accordance with CLSI Guideline EP05-A3. The testing was run for 21 days, including 1 run per day with 2 parts. Ten dummy samples were included in each part to simulate routine testing in the laboratory. Additionally, 10 dummy samples were included in-between both parts to divide the run into distinct parts. Five human urine sample pools and 2 control samples were tested on one cobas c 501, using 3 lots of reagent. Each sample was tested using 2 aliquots in singlicate per part. Mean, Repeatability (within-run precision) and Intermediate precision (within-lab precision) % CV and SD values were calculated. #### Results and Conclusions 4.1.2. | Specimen | Mean (mg/dL) | SD (mg/dL) | CV (%) | |-----------------------------------|--------------|------------|--------| | PreciControl ClinChem<br>Multi 1 | 1.98 | 0.0140 | 0.7 | | PreciControl ClinChem<br>Multi 2 | 3.05 | 0.0242 | 0.8 | | Human Urine 1 | 0.435 | 0.00979 | 2.3 | | Human Urine 2 | 0.737 | 0.00920 | 1.2 | | Human Urine 3 | 1.27 | 0.0107 | 0.8 | | Human Urine 4 | 2.52 | 0.0184 | 0.7 | | Human Urine 5 | 3.30 | 0.0252 | 0.8 | ## Table 2: Repeatability Summary ## Table 3: Intermediate Precision Summary | Specimen | Mean (mg/dL) | SD (mg/dL) | CV (%) | |----------------------------------|--------------|------------|--------| | PreciControl ClinChem<br>Multi 1 | 1.98 | 0.0158 | 0.8 | | PreciControl ClinChem<br>Multi 2 | 3.05 | 0.0267 | 0.9 | | Human Urine 1 | 0.435 | 0.0111 | 2.5 | | Human Urine 2 | 0.737 | 0.0112 | 1.5 | | Human Urine 3 | 1.23 | 0.0130 | 1.1 | | Human Urine 4 | 2.52 | 0.0215 | 0.9 | | Human Urine 5 | 3.30 | 0.0289 | 0.9 | All data passed the predetermined acceptance criteria. {9}------------------------------------------------ #### Analytical Sensitivity 4.2. #### Limit of Blank (LoB) 4.2.1. - The Limit of Blank (LoB) of the Tina-quant Transferrin ver.2 (urine application) assay on the cobas c 501 was determined according to CLSI EP17-A2. LoB determines the highest measurement result that is likely to be observed for a blank sample with a stated probability. The LoB was determined as the 95th percentile of measurements of blank samples. One analyte-free sample was measured on 3 lots of reagent in 10-fold determinations per run in 6 runs, distributed over 4 days, on 1 analyzer. In total, 60 measurements were obtained per reagent lot. Data analysis was based on determination of the 95th percentile of the 60 measured values. LoB Claim: 0.10 mg/dL #### Limit of Detection (LoD) 4.2.2. The Limit of Detection (LoD) of the Tina-quant Transferrin ver.2 (urine application) assay on the cobas c 501 analyzer was determined according to CLSI EP17-A2. The LoD corresponds to the lowest analyte concentration which can be detected (value above the LoB with a probability of 95%). Five human urine samples with low-analyte concentration (approximately up to 4 times the specified LoB) were measured with 3 lots of reagent in 2-fold determinations per run in 6 runs, distributed over 4 days, on 1 analyzer. In total, 60 measurements were obtained per reagent lot. LoD Claim: 0.15 mg/dL #### Limit of Quantitation (LoQ) 4.2.3. The Limit of Quantitation (LoQ) of the Tina-quant Transferrin ver.2 (urine application) assay on the cobas c 501 was determined according to CLSI EP17-A2. LoQ determines the lowest amount of analyte in a sample that can be quantitatively determined with stated accuracy and experimental conditions. The LoO was determined as the lowest concentration of analyte which can be quantified with a total error (% CV) of no more than 20%. {10}------------------------------------------------ A low level sample set was prepared by diluting 5 human urine samples with analyte-free diluent (water). The low level sample set was tested in 5 replicates per sample on 4 days, 1 run per day, on 1 analyzer. LoQ Claim: 0.22 mg/dL with 20% CV #### Results and Conclusions 4.2.4. Table 4: LoB, LoD, and LoQ Experimental Determination | | Lot #1 Result<br>(mg/dL) | Lot #2 Result<br>(mg/dL) | Lot #3 Result<br>(mg/dL) | Claim (mg/dL) | |--------------------------------|--------------------------|--------------------------|--------------------------|---------------| | Limit of Blank (LoB) | 0.0150 | 0.0130 | 0.0150 | 0.10 | | Limit of Detection<br>(LoD) | 0.0382 | 0.0331 | 0.0353 | 0.15 | | Limit of Quantitation<br>(LoQ) | 0.124 | 0.137 | 0.143 | 0.22 | All data passed the predetermined acceptance criteria. #### Linearity/Assay Reportable Range 4.3. #### Regression Analysis 4.3.1. - The linearity study was conducted to determine whether the measurements across the claimed measuring range for each parameter have a linear relationship. The study was performed according to CLSI EP06-A. Dilution series were prepared using the human urine sample pools with transferrin concentrations above the upper end of the measuring range. Dilutions were made using water. The dilution series contained 13 concentrations. Sample dilution levels were measured on 3 lots in triplicate on the cobas c 501 analyzer. Linear regression analysis was done according to EP06-A. In the first step, a linearity check was performed with 1st order (linear) regression and then with higher order models (quadratic and cubic). A linearity check was performed with a 1* order (linear) regression for reagent lots 1 and 2. A linearity check was performed with a 3th order {11}------------------------------------------------ (cubic) regression for reagent lot 3. The linear regression was not forced through the origin. The linear regression was not weighted. #### 4.3.2. Results and Conclusions | Reagent Lot | Linear Regression Equation<br>(mg/dL) | Pearson Correlation<br>Coefficient (r) | Measuring Range Claim<br>(mg/dL) | |-------------|---------------------------------------|----------------------------------------|----------------------------------| | 1 | y = 1.007x - 0.0189 | 0.9999 | 0.22 to 3.5 | | 2 | y = 1.008x - 0.0225 | 0.9999 | 0.22 to 3.5 | | 3 | y = 1.009x - 0.0236 | 0.9997 | 0.22 to 3.5 | All data passed the predetermined acceptance criteria. #### Endogenous Interference Studies 4.4. The purpose of this study was to evaluate endogenous substances for potential interference with the Tina-quant Transferrin ver.2 (urine application) assay measured on the cobas c 501 analyzer. The effect on quantitation of analyte in the presence of potential endogenous interfering substances using Tina-quant Transferrin ver.2 (urine application) was determined on the cobas c 501 analyzer at 2 transferrin concentrations and a dilution set of the added interfering substances. Potential interfering substances evaluated include: albumin, citrate, creatinine, glucose, hemoglobin, IgG, magnesium, oxalate, phosphate, urea, uric acid and urobilinogen. High concentrated stock solutions of the potential interfering substances were prepared in a suitable solvent. Two human urine pools were spiked with defined transferrin concentrations and divided into 2 aliquots. The potential interfering substance was added to 1 aliquot, while the other aliquot was mixed with the same amount of solvent without the potential interfering substance. A dilution series was prepared with 11 dilution steps for each potential interferent by diluting the spiked pool with the dilution pool. Three aliquots per level were tested in 1 run on 1 instrument and 1 lot. The aliquot containing the potential interfering substance had the same transferrin concentration as the aliquot containing no interfering substance. When diluting those 2 aliquots, the transferrin {12}------------------------------------------------ concentration remained constant while the concentration of the potential interferent varied. Thus the effect of increasing concentrations of potential interferent can be determined. The medians of the measured results were compared to the expected results (aliquot with no potential interfering substance) and the recovery was determined (paired difference testing). This procedure was repeated for each of the potential interfering substances. #### Results and Conclusions 4.4.1. | Potential Interferent | No Interference up to: | Claim | |-----------------------|----------------------------------------------|---------------------------------------------------------------------------------| | Albumin | Level 1: 5 g/L<br>Level 2: 5 g/L | No interference ≤ 5000 mg/L | | Calcium | Level 1: 9.92 mmol/L<br>Level 2: 9.80 mmol/L | No interference ≤ 8 mmol/L | | Citrate | Level 1: 11 mmol/L<br>Level 2: 11 mmol/L | No interference ≤ 10 mmol/L | | Creatinine | Level 1: 88 mmol/L<br>Level 2: 88 mmol/L | No interference ≤ 44 mmol/L | | Glucose | Level 1: 388 mmol/L<br>Level 2: 388 mmol/L | No interference ≤ 111 mmol/L | | Hemoglobin | Level 1: 146 mg/dL<br>Level 2: 149 mg/dL | No significant interference up to a<br>hemoglobin concentration of 100<br>mg/dL | | Immunoglobulin (IgG) | Level 1: 1.1 g/L<br>Level 2: 1.1 g/L | No interference ≤ 500 mg/L | | Magnesium | Level 1: 75 mmol/L<br>Level 2: 75 mmol/L | No interference ≤ 75 mmol/L | | Oxalate | Level 1: 3.75 mmol/L<br>Level 2: 3.75 mmol/L | No interference ≤ 2.2 mmol/L | | Phosphate | Level 1: 130 mmol/L<br>Level 2: 130 mmol/L | No interference ≤ 40 mmol/L | | Urea | Level 1: 1500 mmol/L<br>Level 2: 1800 mmol/L | No interference ≤ 1000 mmol/L | | Uric Acid | Level 1: 6 mmol/L<br>Level 2: 6 mmol/L | No interference ≤ 6 mmol/L | | Urobilinogen | Level 1: 15 mg/dL<br>Level 2: 15 mg/dL | No interference ≤ 15 mg/dL | All data passed the predetermined acceptance criteria. {13}------------------------------------------------ #### Exogenous Interferences – Drugs 4.5. The purpose of this study was to evaluate drugs for potential interference to the Tina-quant Transferrin ver.2 (urine application) assay measured on the cobas c 501 analyzer. Two human urine sample pools spiked with approximately 0.433 and 2.48 mg/dL transferrin concentrations were divided into 2 aliquots. One aliquot of each concentration was used as the reference sample for transferrin concentration and was not spiked with the drugs, but only the solvent for the drug. The other aliquots, with either the high or low transferrin concentration, were spiked with the respective amount of drug. Each aliquot containing a defined transferrin concentration and spiked with drug was measured in triplicate in 1 run on 1 analyzer and 1 lot. The defined drug compounds were spiked into samples with concentrations according to EP07-A2 or higher. #### Results and Conclusions 4.5.1. - | Potential Drug Interferent | No interference up to: | |----------------------------|------------------------| | Acetaminophen | 3000 mg/L | | Ascorbic acid | 4000 mg/L | | Cefoxitin | 12000 mg/L | | Gentamicin sulfate | 400 mg/L | | Ibuprofen | 500 mg/L | | Levodopa | 1000 mg/L | | Methyldopa | 2000 mg/L | | N-Acetylcysteine | 10 mg/L | | Ofloxacine | Interference Claim | | Phenazopyridine | 50 mg/L | | Salicyluric acid | 100 mg/L | | Tetracycline | 300 mg/L | Table 7: Potentially Interfering Drugs and Test Concentration Results All data passed the predetermined acceptance criterion except for ofloxacine. Claim: Drugs: No interference was found at the therapeutic concentrations using common drug panels. Exceptions: Ofloxacine causes artificially high transferrin results. {14}------------------------------------------------ #### Method Comparison to Predicate 4.6. A method comparison of the Tina-quant Transferrin ver.2 (urine application) assay on the cobas c 501 versus the predicate device, N Antisera to Human Transferrin (Siemens) on the BN ProSpec analyzer was conducted. One hundred and seven routine fresh, never-frozen human urine samples were used in the method comparison testing. One of the 109 urine samples collected was removed due to a pH >8 and one was removed due to a measured value outside of the defined measuring range. No patient information was obtained. No samples were spiked or diluted. The samples were tested in singlicate using the N Antisera to Human Transferrin assay (K053075) from Siemens on the BN ProSpec System and the Tina-quant Transferrin ver.2 (urine application) assay on the cobas c 501 analyzer. The data was evaluated using Passing Bablok Regression analysis. 4.6.1. Results and Conclusions Regression analysis results (mg/dL): y = 1.007x + 0.0052, r = 0.995 Predetermined acceptance criteria for Method Comparison to the Predicate were met. #### CLINICAL PERFORMANCE EVALUATION 5. Not applicable. #### ADDITIONAL INFORMATION 6. #### Other Devices Required But Not Provided: 6.1. The Tina-quant Transferrin ver.2 (urine application) continues to use: - Calibrator f. a. s. Proteins (K133330) . - PreciControl ClinChem Multi 1 (K133330) . {15}------------------------------------------------ - PreciControl ClinChem Multi 2 (K133330) . - Precinorm Protein (K133330) • - Precipath Protein (K133330) • - Diluent NaCl 9% (21 CFR § 864.4010, Class I 510(k) exempt) . #### CONCLUSIONS 7. The submitted information in this premarket notification supports a substantial equivalence decision.