ACL TOP Family 70 Series

{0} FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY ## I Background Information: A 510(k) Number K231031 B Applicant Instrumentation Laboratory Company C Proprietary and Established Names ACL TOP Family 70 Series D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | GKP | Class II | 21 CFR 864.5400 - Coagulation Instrument | HE - Hematology | ## II Submission/Device Overview: A Purpose for Submission: To release the updated ACL TOP Family 50 Series models under the trade name ACL TOP Family 70 Series. B Type of Test: Clotting, chromogenic, and immunological coagulation assays ## III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} The ACL TOP Family 70 Series (ACL TOP 370, ACL TOP 570 and ACL TOP 770 / 770s / 770 LAS) are bench top, fully automated, random access analyzers designed specifically for in vitro diagnostic clinical use by health care professionals in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. ## C Special Conditions for Use Statement(s): Rx - For Prescription Use Only ## IV Device/System Characteristics: ### A Device Description: The ACL TOP Family 70 Series are fully automated coagulation analyzers that utilize the same intuitive software, the same consumables, reagents, calibrators and controls, and provide the same analytical methodology for routine and specialty assay result reporting as the predicate ACL TOP Family 50 Series. The ACL TOP Family 70 Series instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate ACL TOP Family 50 Series: - Coagulometric (Turbidimetric) Measurements - Chromogenic (Absorbance) Measurements - Immunological Measurements The ACL TOP Family 70 Series also offers the same pre-analytical features available on the ACL TOP Family 50 Series. These features alert the instrument operator to a potential HIL (Hemoglobin, Icteric and Lipemia) interference situation specific to the assays requested for a sample, underfilled sample tubes or a detected clog. ### B Instrument Description Information: 1. **Instrument Name:** ACL TOP Family 70 Series (ACL TOP 370, ACL TOP 570, ACL TOP 770, ACL TOP 770s, ACL TOP 770 LAS) 2. **Specimen Identification:** Samples, reagents, and diluents are identified by a barcode reader. 3. **Specimen Sampling and Handling:** Draw blood into a light blue top tube containing 3.2% sodium citrate. Using other anticoagulants may cause invalid results. Fill to the proper level, indicated by a fill line on the tube. Gently invert six times to mix. Process immediately. 4. **Calibration:** The ACL TOP instrument makes dilutions, adds reagents, and takes readings, then generates a calibration curve. The instrument can store the ten most recent calibrations. However, only one calibration can be validated at any time. K231031 - Page 2 of 14 {2} K231031 - Page 3 of 14 5. Quality Control: The ACL TOP instrument provides a Quality Control (QC) program that allows user to monitor performance characteristics of an analytical system for precision and accuracy as well as alert user to sources of unacceptable analytical performance. V Substantial Equivalence Information: A Predicate Device Name(s): ACL Top Family 50 Series: ACL Top 350 CTS; ACL Top 550 CTS; ACL Top 750; ACL Top 750 CTS; ACL Top 750 LAS B Predicate 510(k) Number(s): K150877 C Comparison with Predicate(s): | Device & Predicate Device(s): | K231031 | K150877 | | --- | --- | --- | | Device Trade Name | ACL TOP Family 70 Series | ACL TOP Family 50 Series | | General Device Characteristic Similarities | | | | Intended Use/Indications For Use | The ACL TOP Family 70 Series (ACL TOP 370, ACL TOP 570 and ACL TOP 770 / 770s / 770 LAS) are bench top, fully automated, random access analyzers designed specifically for in vitro diagnostic clinical use by health care professionals in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. | The ACL TOP Family 50 Series (ACL TOP 350 CTS, ACL TOP 550 CTS, ACL TOP 750, ACL TOP 750 CTS, ACL TOP 750 LAS) are bench top, fully automated, random access analyzers designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provides results for both direct hemostasis measurements and calculated parameters. | | Test Methodology | • Coagulometric measurement • Chromogenic measurement • Immunological measurement | Same | | Wavelengths | • 405 nm • 535 nm | Same | {3} K231031 - Page 4 of 14 | | • 671 nm | | | --- | --- | --- | | Test Menu | • Clotting Assays • Chromogenic Assays • Immunological Assays | Same | | Sample Matrix | 3.2% citrated plasma | Same | | Sample Handling | Cap piercing, onboard storage | Same | | Fluidic Handling | Aspiration, dispense, mixing, rinse, clean, temperature control, bulk fluids | Same | | Reaction and Detection | Optics, temperature control | Same | | Quality Control | Automated QC | Same | | Reagents, Controls and Calibrators | Packaging, formulation, performance claims in labeling | Same | | Onboard Reagent Storage | Stirring, temperature control | Same | | System Software | Hardware control, user interface except as noted in Differences below | Same | | Pre-Analytical HIL Check | Standard for all models: Third measurement wavelength at 535 nm and an additional emitter control channel | Same | | Tube Fill Height Check | Standard for all models | Same | | Clog Detection | Standard for all models | Same | | General Device Characteristic Differences | | | | External Skins and Chassis | On-market instrument appearance | Updated instrument appearance | | Control Module | 22-inch Color Touchscreen Monitor | 17-inch Color Touchscreen Monitor | | Software | Software v1.3 • Designed for the ACL TOP Family 70 Series using predicate ACL TOP Family 50 Series SW v6.5 as a foundation • Updated Graphical User Interface (GUI) for aesthetics (e.g., higher resolution icons) • Added the Study Mode internal function to support laboratories in more efficiently meeting their | Software v6.5 | {4} K231031 - Page 5 of 14 | | Quality System requirements. The Study Mode provides the interface for laboratories to organize and execute their internal performance studies, including collection of data for lot comparison, instrument comparison, or reference intervals. • Added permission-based remote-control function for desktop sharing and remote software delivery and upgrades, utilizing security and privacy controls by design and installed by default. | | | --- | --- | --- | ## VI Standards/Guidance Documents Referenced: CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures (3rd Edition); IEC 61326-1:2020: Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements; IEC 61326-2-6:2020: Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: IVD medical equipment; IEC 61010-1:2017: Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements; IEC 61010-2-101:2018 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: IVD medical equipment; IEC 61010-2-010:2019 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-010: Heating; IEC 60601-1-2:2020: Edition Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance. ## VII Performance Characteristics (if/when applicable): ### A Analytical Performance: 1. **Precision/Reproducibility:** Precision testing was performed on selected representative assays to evaluate the following test methodologies: - Latex agglutination - Clotting (Calibrated) {5} - Clotting (Non-calibrated) - Chromogenic (Calibrated) These selected assays include HemosIL D-Dimer HS 500 (K172903), HemosIL Factor VIII deficient plasma (K034007), HemosIL RecombiPlasTin 2G (K070005), and HemosIL Liquid Anti-Xa (K213464) represent the highest volume used in the market for each test methodology. ## D-Dimer Precision Study Precision testing was performed for D-dimer with one reagent lot of HemosIL D-Dimer HS 500 using representative ACL TOP Family 70 Series models (ACL TOP 370, ACL TOP 570, and ACL TOP 770). For each material, testing was executed for 20 days at two runs per day, 2 replicates per run (n=80) per instrument model. Low and high controls, as well as two sample pools, were tested. All acceptance criteria for repeatability and within-laboratory precision were met. ### ACL TOP 370 D-Dimer Precision Summary | Material | N | Mean (ng/mL FEU) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Low Control | 80 | 710.7 | 38.8 | 5.5 | 0.0 | 0.0 | 18.8 | 2.6 | 43.1 | 6.1 | | High Control | 80 | 2353.4 | 48.0 | 2.0 | 8.8 | 0.4 | 23.2 | 1.0 | 54.0 | 2.3 | | Cut-off Pool | 80 | 619.8 | 24.5 | 4.0 | 0.0 | 0.0 | 13.1 | 2.1 | 27.8 | 4.5 | | High Pool | 80 | 2373.8 | 33.1 | 1.4 | 14.4 | 0.6 | 13.8 | 0.6 | 38.6 | 1.6 | ### ACL TOP 570 D-Dimer Precision Summary | Material | N | Mean (ng/mL FEU) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Low Control | 80 | 674.3 | 34.4 | 5.1 | 4.8 | 0.7 | 8.5 | 1.3 | 35.8 | 5.3 | | High Control | 80 | 2472.4 | 31.6 | 1.3 | 22.0 | 0.9 | 6.1 | 0.2 | 39.0 | 1.6 | | Cut-off Pool | 80 | 590.2 | 36.7 | 6.2 | 11.8 | 2.0 | 0.0 | 0.0 | 38.5 | 6.5 | | High Pool | 80 | 2529.5 | 21.7 | 0.9 | 19.0 | 0.8 | 0.0 | 0.0 | 28.8 | 1.1 | ### ACL TOP 770 D-Dimer Precision Summary | Material | N | Mean (ng/mL FEU) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Low Control | 80 | 676.9 | 30.5 | 4.5 | 0.0 | 0.0 | 10.2 | 1.5 | 32.2 | 4.8 | | High Control | 80 | 2488.9 | 41.3 | 1.7 | 0.0 | 0.0 | 32.2 | 1.3 | 52.4 | 2.1 | | Cut-off Pool | 80 | 569.9 | 36.5 | 6.4 | 0.0 | 0.0 | 6.4 | 1.1 | 37.1 | 6.5 | | High Pool | 80 | 2486.6 | 50.2 | 2.0 | 0.0 | 0.0 | 0.0 | 0.0 | 50.2 | 2.0 | K231031 - Page 6 of 14 {6} D-Dimer Instrument-to-Instrument Variability | Material | N | Mean (ng/mL FEU) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Between-Instrument | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Low Control | 240 | 687.3 | 34.7 | 5.1 | 0.0 | 0.0 | 13.3 | 1.9 | 19.8 | 2.9 | 42.1 | 6.1 | | High Control | 240 | 2438.2 | 40.9 | 1.7 | 11.0 | 0.5 | 23.2 | 1.0 | 73.6 | 3.0 | 88.0 | 3.6 | | Cut-off Pool | 240 | 593.3 | 33.1 | 5.6 | 4.8 | 0.8 | 7.6 | 1.3 | 24.8 | 4.2 | 42.3 | 7.1 | | High Pool | 240 | 2463.3 | 36.9 | 1.5 | 9.5 | 0.4 | 0.0 | 0.0 | 80.3 | 3.3 | 88.9 | 3.6 | Factor VIII Precision Study Precision testing was performed for factor VIII with one reagent lot of HemosIL Factor VIII deficient plasma using representative ACL TOP Family 70 Series models (ACL TOP 370, ACL TOP 570, and ACL TOP 770). For each material, testing was executed for 20 days at two runs per day, 2 replicates per run (n=80) per material per instrument model. Normal and abnormal controls, as well as two sample pools, were tested. All acceptance criteria for repeatability and within-laboratory precision were met. ACL TOP 370 Factor VIII Precision Summary | Material | N | Mean (%) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Normal Control | 80 | 92.06 | 2.58 | 2.8 | 1.63 | 1.8 | 1.29 | 1.4 | 3.31 | 3.6 | | Abnormal Control | 80 | 28.44 | 0.78 | 2.8 | 0.95 | 3.3 | 0.57 | 2.0 | 1.35 | 4.8 | | Plasma Pool 1 | 80 | 31.59 | 0.82 | 2.6 | 0.80 | 2.5 | 0.79 | 2.5 | 1.39 | 4.4 | | Plasma Pool 2 | 80 | 8.43 | 0.27 | 3.2 | 0.00 | 0.0 | 0.15 | 1.7 | 0.30 | 3.6 | ACL TOP 570 Factor VIII Precision Summary | Material | N | Mean (%) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Normal Control | 80 | 92.66 | 2.67 | 2.9 | 2.26 | 2.4 | 0.00 | 0.0 | 3.50 | 3.8 | | Abnormal Control | 80 | 28.78 | 0.64 | 2.2 | 0.87 | 3.0 | 0.00 | 0.0 | 1.08 | 3.7 | | Plasma Pool 1 | 80 | 32.45 | 2.54 | 7.8 | 0.00 | 0.0 | 0.66 | 2.0 | 2.62 | 8.1 | | Plasma Pool 2 | 80 | 9.01 | 0.22 | 2.4 | 0.13 | 1.5 | 0.20 | 2.2 | 0.32 | 3.6 | ACL TOP 770 Factor VIII Precision Summary | Material | N | Mean (%) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Normal Control | 80 | 94.22 | 2.43 | 2.6 | 1.20 | 1.3 | 1.69 | 1.8 | 3.19 | 3.4 | | Abnormal Control | 80 | 29.58 | 0.59 | 2.0 | 0.95 | 3.2 | 0.86 | 2.9 | 1.41 | 4.8 | | Plasma Pool 1 | 80 | 33.30 | 0.90 | 2.7 | 0.64 | 1.9 | 0.65 | 1.9 | 1.28 | 3.8 | | Plasma Pool 2 | 80 | 9.01 | 0.22 | 2.4 | 0.00 | 0.0 | 0.11 | 1.2 | 0.24 | 2.7 | K231031 - Page 7 of 14 {7} Factor VIII Instrument-to-Instrument Variability | Material | N | Mean (%) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Between-Instrument | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Normal Control | 240 | 92.98 | 2.56 | 2.8 | 1.75 | 1.9 | 1.21 | 1.3 | 1.01 | 1.1 | 3.48 | 3.7 | | Abnormal Control | 240 | 28.93 | 0.68 | 2.3 | 0.92 | 3.2 | 0.56 | 2.0 | 0.55 | 1.9 | 1.39 | 4.8 | | Plasma Pool 1 | 240 | 32.45 | 1.63 | 5.0 | 0.47 | 1.4 | 0.70 | 2.2 | 0.81 | 2.5 | 2.00 | 6.2 | | Plasma Pool 2 | 240 | 8.82 | 0.23 | 2.7 | 0.03 | 0.3 | 0.15 | 1.8 | 0.33 | 3.8 | 0.44 | 4.9 | Prothrombin Time (PT) Precision Study Precision testing was performed for prothrombin time (PT) with one reagent lot of HemosIL RecombiPlasTin 2G using representative ACL TOP Family 70 Series models (ACL TOP 370, ACL TOP 570, and ACL TOP 770). For each material, testing was executed for 20 days at two runs per day, 2 replicates per run (n=80) per material per instrument model. Three control levels, as well as one sample pool, were tested. All acceptance criteria for repeatability and within-laboratory precision were met. ACL TOP 370 Prothrombin Time Precision Summary | Material | N | Mean (sec) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Normal Control | 80 | 11.97 | 0.09 | 0.8 | 0.09 | 0.8 | 0.16 | 1.4 | 0.21 | 1.7 | | Low Abn Control | 80 | 23.23 | 0.19 | 0.8 | 0.44 | 1.9 | 0.66 | 2.8 | 0.81 | 3.5 | | High Abn Control | 80 | 36.62 | 0.39 | 1.1 | 0.95 | 2.6 | 1.28 | 3.5 | 1.64 | 4.5 | | Plasma Pool | 80 | 38.00 | 0.47 | 1.2 | 0.61 | 1.6 | 1.29 | 3.4 | 1.50 | 4.0 | ACL TOP 570 Prothrombin Time Precision Summary | Material | N | Mean (sec) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Normal Control | 80 | 11.84 | 0.10 | 0.9 | 0.17 | 1.4 | 0.11 | 1.0 | 0.23 | 1.9 | | Low Abn Control | 80 | 23.07 | 0.21 | 0.9 | 0.39 | 1.7 | 0.73 | 3.2 | 0.85 | 3.7 | | High Abn Control | 80 | 36.72 | 0.30 | 0.8 | 1.01 | 2.8 | 1.42 | 3.9 | 1.77 | 4.8 | | Plasma Pool | 80 | 37.82 | 0.40 | 1.1 | 0.88 | 2.3 | 1.14 | 3.0 | 1.50 | 4.0 | ACL TOP 770 Prothrombin Time Precision Summary | Material | N | Mean (sec) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Normal Control | 80 | 11.94 | 0.07 | 0.6 | 0.10 | 0.9 | 0.17 | 1.4 | 0.21 | 1.8 | | Normal Control | 80 | 23.24 | 0.15 | 0.7 | 0.37 | 1.6 | 0.75 | 3.2 | 0.85 | 3.7 | | Low Abn Control | 80 | 36.93 | 0.29 | 0.8 | 0.89 | 2.4 | 1.57 | 4.3 | 1.83 | 5.0 | | High Abn Control | 80 | 38.10 | 0.34 | 0.9 | 0.71 | 1.9 | 1.32 | 3.5 | 1.54 | 4.0 | K231031 - Page 8 of 14 {8} Prothrombin Time Instrument-to-Instrument Variability | Material | N | Mean (sec) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Between-Instrument | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Normal Control | 240 | 11.92 | 0.09 | 0.8 | 0.13 | 1.0 | 0.15 | 1.3 | 0.06 | 0.5 | 0.22 | 1.9 | | Normal Control | 240 | 23.18 | 0.19 | 0.8 | 0.40 | 1.7 | 0.72 | 3.1 | 0.00 | 0.0 | 0.84 | 3.6 | | Low Abn Control | 240 | 36.76 | 0.33 | 0.9 | 0.95 | 2.6 | 1.43 | 3.9 | 0.00 | 0.0 | 1.75 | 4.8 | | High Abn Control | 240 | 37.97 | 0.41 | 1.1 | 0.74 | 2.0 | 1.25 | 3.3 | 0.00 | 0.0 | 1.51 | 4.0 | Fibrinogen Precision Study Precision testing was performed for fibrinogen with one reagent lot of HemosIL RecombiPlasTin 2G using representative ACL TOP Family 70 Series models (ACL TOP 370, ACL TOP 570, and ACL TOP 770). For each material, testing was executed for 20 days at two runs per day, 2 replicates per run (n=80) per material per instrument model. Two control levels, as well as two sample pools, were tested. All acceptance criteria for repeatability and within-laboratory precision were met. ACL TOP 370 Fibrinogen Precision Summary | Material | N | Mean (mg/dL) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Normal Control | 80 | 347.9 | 3.7 | 1.1 | 3.2 | 0.9 | 11.4 | 3.3 | 12.4 | 3.6 | | Low Fib Control | 80 | 144.4 | 5.3 | 3.6 | 4.0 | 2.8 | 2.7 | 1.8 | 7.1 | 4.9 | | Normal Pool | 80 | 291.2 | 4.3 | 1.5 | 7.8 | 2.7 | 8.5 | 2.9 | 12.3 | 4.2 | | Abnormal Pool | 80 | 139.0 | 3.2 | 2.3 | 3.5 | 2.5 | 4.8 | 3.5 | 6.8 | 4.9 | ACL TOP 570 Fibrinogen Precision Summary | Material | N | Mean (mg/dL) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Normal Control | 80 | 341.5 | 2.9 | 0.8 | 2.9 | 0.8 | 13.8 | 4.0 | 14.4 | 4.2 | | Low Fib Control | 80 | 145.7 | 8.9 | 6.1 | 4.2 | 2.9 | 0.0 | 0.0 | 9.8 | 6.8 | | Normal Pool | 80 | 287.5 | 3.3 | 1.1 | 5.9 | 2.1 | 8.2 | 2.9 | 10.7 | 3.7 | | Abnormal Pool | 80 | 140.6 | 3.8 | 2.7 | 3.3 | 2.3 | 4.2 | 3.0 | 6.5 | 4.6 | ACL TOP 770 Fibrinogen Precision Summary | Material | N | Mean (mg/dL) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Normal Control | 80 | 339.1 | 3.1 | 0.9 | 2.6 | 0.8 | 12.6 | 3.7 | 13.2 | 3.9 | | Low Fib Control | 80 | 140.7 | 9.0 | 6.4 | 5.7 | 4.0 | 4.1 | 2.9 | 11.4 | 8.1 | | Normal Pool | 80 | 284.5 | 6.0 | 2.1 | 4.0 | 1.4 | 8.1 | 2.8 | 10.9 | 3.8 | | Abnormal Pool | 80 | 136.9 | 5.9 | 4.3 | 0.0 | 0.0 | 3.5 | 2.6 | 6.8 | 5.0 | K231031 - Page 9 of 14 {9} Fibrinogen Instrument-to-Instrument Variability | Material | N | Mean (mg/dL) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Between-Instrument | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | Normal Control | 240 | 342.9 | 3.2 | 0.9 | 2.9 | 0.8 | 12.6 | 3.7 | 3.5 | 1.0 | 13.8 | 4.0 | | Low Fib Control | 240 | 143.6 | 7.9 | 5.5 | 4.7 | 3.3 | 2.5 | 1.7 | 2.2 | 1.6 | 9.8 | 6.8 | | Normal Pool | 240 | 287.7 | 4.7 | 1.6 | 6.1 | 2.1 | 8.3 | 2.9 | 2.6 | 0.9 | 11.6 | 4.0 | | Abnormal Pool | 240 | 138.8 | 4.4 | 3.2 | 2.8 | 2.0 | 4.2 | 3.0 | 1.4 | 1.0 | 6.9 | 4.9 | # Heparin Precision Study Precision testing was performed for heparin with one reagent lot of HemosIL Liquid Anti-Xa using representative ACL TOP Family 70 Series models (ACL TOP 370, ACL TOP 570, and ACL TOP 770). For each material, testing was executed for 20 days at two runs per day, 2 replicates per run $(n = 80)$ per material per instrument model. Four control levels (2 for UF heparin; 2 for LMW heparin), as well as two sample pools (1 for UF heparin; 1 for LMW heparin), were tested. All acceptance criteria for repeatability and within-laboratory precision were met. ACL TOP 370 Heparin Precision Summary | Material | N | Mean (IU/mL) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | UF Low Control | 80 | 0.37 | 0.007 | 1.8 | 0.006 | 1.7 | 0.000 | 0.0 | 0.009 | 2.5 | | UF High Control | 80 | 0.67 | 0.009 | 1.3 | 0.007 | 1.0 | 0.007 | 1.0 | 0.013 | 2.0 | | UF Pool | 80 | 0.56 | 0.010 | 1.8 | 0.009 | 1.7 | 0.010 | 1.8 | 0.017 | 3.1 | | LMW High Control | 80 | 1.53 | 0.022 | 1.4 | 0.019 | 1.3 | 0.005 | 0.3 | 0.030 | 1.9 | | LMW Low Control | 80 | 0.61 | 0.016 | 2.7 | 0.012 | 2.0 | 0.000 | 0.0 | 0.020 | 3.3 | | LMW Pool | 80 | 0.68 | 0.015 | 2.2 | 0.008 | 1.2 | 0.008 | 1.2 | 0.019 | 2.7 | ACL TOP 570 Heparin Precision Summary | Material | N | Mean (IU/mL) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | UF Low Control | 80 | 0.37 | 0.010 | 2.7 | 0.007 | 1.8 | 0.000 | 0.0 | 0.012 | 3.3 | | UF High Control | 80 | 0.67 | 0.015 | 2.3 | 0.011 | 1.6 | 0.004 | 0.7 | 0.019 | 2.9 | | UF Pool | 80 | 0.58 | 0.013 | 2.3 | 0.014 | 2.5 | 0.000 | 0.0 | 0.019 | 3.3 | | LMW High Control | 80 | 1.54 | 0.027 | 1.7 | 0.056 | 3.6 | 0.000 | 0.0 | 0.062 | 4.0 | | LMW Low Control | 80 | 0.61 | 0.018 | 2.9 | 0.021 | 3.4 | 0.005 | 0.9 | 0.028 | 4.6 | | LMW Pool | 80 | 0.70 | 0.022 | 3.2 | 0.028 | 4.1 | 0.000 | 0.0 | 0.036 | 5.1 | K231031 - Page 10 of 14 {10} ACL TOP 770 Heparin Precision Summary | Material | N | Mean (IU/mL) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | UF Low Control | 80 | 0.36 | 0.005 | 1.4 | 0.004 | 1.1 | 0.000 | 0.0 | 0.006 | 1.8 | | UF High Control | 80 | 0.66 | 0.010 | 1.5 | 0.006 | 0.9 | 0.002 | 0.3 | 0.012 | 1.8 | | UF Pool | 80 | 0.56 | 0.007 | 1.2 | 0.010 | 1.7 | 0.003 | 0.6 | 0.012 | 2.2 | | LMW High Control | 80 | 1.50 | 0.029 | 1.9 | 0.008 | 0.5 | 0.015 | 1.0 | 0.033 | 2.2 | | LMW Low Control | 80 | 0.58 | 0.013 | 2.2 | 0.007 | 1.3 | 0.003 | 0.5 | 0.015 | 2.6 | | LMW Pool | 80 | 0.66 | 0.013 | 2.0 | 0.008 | 1.3 | 0.000 | 0.0 | 0.016 | 2.4 | Heparin Instrument-to-Instrument Variability | Material | N | Mean (IU/mL) | Repeatability (Within-Run) | | Between-Run | | Between-Day | | Between-Instrument | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | UF Low Control | 240 | 0.37 | 0.008 | 2.1 | 0.006 | 1.6 | 0.000 | 0.0 | 0.005 | 1.2 | 0.011 | 2.9 | | UF High Control | 240 | 0.67 | 0.012 | 1.8 | 0.008 | 1.2 | 0.005 | 0.7 | 0.005 | 0.8 | 0.016 | 2.4 | | UF Pool | 240 | 0.57 | 0.010 | 1.8 | 0.011 | 2.0 | 0.006 | 1.0 | 0.009 | 1.6 | 0.019 | 3.3 | | LMW High Control | 240 | 1.53 | 0.026 | 1.7 | 0.034 | 2.2 | 0.000 | 0.0 | 0.023 | 1.5 | 0.049 | 3.2 | | LMW Low Control | 240 | 0.60 | 0.016 | 2.6 | 0.015 | 2.4 | 0.000 | 0.0 | 0.014 | 2.3 | 0.026 | 4.3 | | LMW Pool | 240 | 0.68 | 0.017 | 2.5 | 0.018 | 2.6 | 0.000 | 0.0 | 0.016 | 2.4 | 0.030 | 4.3 | 2. Linearity: Refer to K150877 3. Analytical Specificity/Interference: Refer to K150877 4. Accuracy (Instrument): Method Comparison Studies D-Dimer Method Comparison A method comparison study for D-Dimer was performed with one lot of HemosIL D-Dimer HS 500 to compare the performance on representative ACL TOP Family 70 Series models (ACL TOP 370, ACL TOP 570, and ACL TOP 770) to a representative ACL TOP Family 50 Series model (ACL TOP 750 CTS). The study included 138 native clinical patient samples, spanning the assay's analytical measuring range (AMR) to demonstrate equivalent performance between the subject device and predicate device. The first replicate result on the candidate device (ACL TOP Family 70 Series models) was compared to the duplicate mean on the predicate device (ACL TOP Family 50 Series). K231031 - Page 11 of 14 {11} D-Dimer method comparison results are summarized in the table below. All acceptance criteria were met, supporting the comparable performance of the ACL TOP Family 70 Series (subject device) to the ACL TOP Family 50 Series (predicate device) with the representative latex agglutination assay. D-Dimer Method Comparison Results Summary | Comparison | N | Range (ng/mL FEU) | r | Slope (95% CI) | Intercept (95% CI) | | --- | --- | --- | --- | --- | --- | | ACL TOP 370 vs. ACL TOP 750 CTS | 119 | 233 to 106,815 | 0.998 | 1.006 (0.9936, 1.013) | 5.701 (-16.66, 24.19) | | ACL TOP 570 vs. ACL TOP 750 CTS | 120 | 239 to 104,313 | 0.998 | 1.003 (0.9930, 1.014) | 51.78 (27.91, 75.06) | | ACL TOP 770 vs. ACL TOP 750 CTS | 116 | 230 to 109,752 | 0.998 | 1.022 (1.005, 1.034) | 0.557 (-37.66, 19.11) | # Factor VIII Method Comparison Study A method comparison study for factor VIII was performed with one lot of HemosIL Factor VIII deficient plasma (run with HemosIL SynthASil) to compare the performance on representative ACL TOP Family 70 Series models (ACL TOP 370, ACL TOP 570, and ACL TOP 770) to a representative ACL TOP Family 50 Series model (ACL TOP 750 CTS). The first replicate result on the candidate device (ACL TOP Family 70 Series models) was compared to the duplicate mean on the predicate device (ACL TOP Family 50 Series). The study included 148 samples spanning the assay's AMR to demonstrate the equivalent performance between the subject and predicate devices. Factor VIII method comparison results are summarized in the table below. All acceptance criteria were met, supporting the comparable performance of the ACL TOP Family 70 Series (subject device) to the ACL TOP Family 50 Series (predicate device) with the representative clotting (calibrated) assay. Factor VIII Method Comparison Results Summary | Comparison | N | Range (% Activity) | r | Slope (95% CI) | Intercept (95% CI) | | --- | --- | --- | --- | --- | --- | | ACL TOP 370 vs. ACL TOP 750 CTS | 104 | 0.5 to 156.6 | 0.998 | 1.001 (0.9849, 1.012) | -0.5437 (-1.766, -0.1074) | | ACL TOP 570 vs. ACL TOP 750 CTS | 104 | 0.5 to 148.4 | 0.996 | 1.024 (1.004, 1.043) | -0.5256 (-2.2118, -0.1011) | | ACL TOP 770 vs. ACL TOP 750 CTS | 104 | 0.7 to 153 | 0.998 | 1.006 (0.9954, 1.018) | -0.0587 (-0.3945, 0.0789) | # Prothrombin Time (PT) Method Comparison Study A method comparison study for prothrombin time (PT) was performed with one lot of HemosIL RecombiPlasTin 2G to compare the performance on representative ACL TOP Family 70 Series models (ACL TOP 370, ACL TOP 570 and ACL TOP 770 LAS) to a representative ACL TOP Family 50 Series model (ACL TOP 750 CTS). The first replicate result on the candidate device (ACL TOP Family 70 Series models) was compared to the duplicate mean on the predicate device (ACL TOP Family 50 Series). The study included K231031 - Page 12 of 14 {12} 121 native patient samples, spanning the normal and abnormal range to demonstrate the equivalent performance between the subject and predicate devices. Prothrombin Time method comparison results are summarized in the table below. All acceptance criteria were met, supporting the comparable performance of the ACL TOP Family 70 Series (subject device) to the ACL TOP Family 50 Series (predicate device) with the representative clotting (non-calibrated) assay. Prothrombin Time Method Comparison Results Summary | Comparison | N | Range (Seconds) | r | Slope (95% CI) | Intercept (95% CI) | | --- | --- | --- | --- | --- | --- | | ACL TOP 370 vs. ACL TOP 750 CTS | 115 | 10.5 to 56.1 | 0.999 | 1.000 (1.000, 1.009) | 0.0500 (-0.1051, 0.050) | | ACL TOP 570 vs. ACL TOP 750 CTS | 116 | 10.45 to 55.7 | 1.000 | 1.000 (1.000, 1.011) | 0.000 (-0.1550, 0.000) | | ACL TOP 770 LAS vs. ACL TOP 750 CTS | 116 | 10.5 to 56.6 | 1.000 | 1.012 (1.007, 1.018) | -0.0939 (-0.1690, -0.0196) | # Fibrinogen Method Comparison Study A method comparison study for fibrinogen was performed with one lot of HemosIL RecombiPlasTin 2G to compare the performance on representative ACL TOP Family 70 Series models (ACL TOP 370, ACL TOP 570 and ACL TOP 770 LAS) to a representative ACL TOP Family 50 Series model (ACL TOP 750 CTS). The first replicate result on the candidate device (ACL TOP Family 70 Series models) was compared to the duplicate mean on the predicate device (ACL TOP Family 50 Series). The study included 121 native patient samples, spanning the assay's AMR to demonstrate the equivalent performance between the subject and predicate devices. Fibrinogen method comparison results are summarized in the table below. All acceptance criteria were met, supporting the comparable performance of the ACL TOP Family 70 Series (subject device) to the ACL TOP Family 50 Series (predicate device) with the representative clotting (calibrated) assay. Fibrinogen Method Comparison Summary of Passing-Bablok Regression Results | Comparison | N | Range (mg/dL) | r | Slope (95% CI) | Intercept (95% CI) | | --- | --- | --- | --- | --- | --- | | ACL TOP 370 vs. ACL TOP 750 CTS | 113 | 68.0 to 653.0 | 0.999 | 1.003 (0.9961, 1.009) | 4.963 (3.446, 6.907) | | ACL TOP 570 vs. ACL TOP 750 CTS | 114 | 68.0 to 660.0 | 0.997 | 1.007 (1.000, 1.014) | 4.976 (2.604 to 7.000) | | ACL TOP 770 LAS vs. ACL TOP 750 CTS | 114 | 62.0 to 640.0 | 0.999 | 0.9756 (0.9693, 0.9831) | -1.122 (-3.644, 0.5549) | # Heparin Method Comparison Study Method comparison testing for heparin was performed with one lot of HemosIL Liquid Anti-Xa to compare the performance on representative ACL TOP Family 70 Series models (ACL TOP 370, ACL TOP 570, and ACL TOP 770) to a representative ACL TOP Family 50 Series K231031 - Page 13 of 14 {13} model (ACL TOP 750 CTS). The first replicate result on the candidate device (ACL TOP Family 70 Series models) was compared to the duplicate mean on the predicate device (ACL TOP Family 50 Series). The study included 260 samples spanning the assay's AMR to demonstrate the equivalent performance between the subject and predicate devices. Heparin method comparison results are summarized in the table below. All acceptance criteria were met, supporting the comparable performance of the ACL TOP Family 70 Series (subject device) to the ACL TOP Family 50 Series (predicate device) with the representative chromogenic (calibrated) assay. Heparin Method Comparison Summary of Passing-Bablok Regression Results | Comparison | N | Range (IU/mL) | r | Slope (95% CI) | Intercept (95% CI) | | --- | --- | --- | --- | --- | --- | | ACL TOP 370 vs. ACL TOP 750 CTS | 209 | 0.03 to 1.98 | 0.997 | 0.9950 (0.9870, 1.000) | -0.0129 (-0.0200, -0.0058) | | ACL TOP 570 vs. ACL TOP 750 CTS | 204 | 0.03 to 2.06 | 0.997 | 1.005 (0.996, 1.020) | -0.0204 (-0.0306, -0.0100) | | ACL TOP 770 vs. ACL TOP 750 CTS | 207 | 0.03 to 1.98 | 0.999 | 0.9804 (0.9716, 0.9888) | -0.0145 (-0.0203, -0.0091) | 5. Carry-Over: Refer to K150877 B Other Supportive Instrument Performance Characteristics Data: Refer to K150877 VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. IX Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. K231031 - Page 14 of 14