← Product Code [GGN](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN) · K100716 # AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 (K100716) _Aalto Scientific, Ltd. · GGN · Jun 23, 2011 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K100716 ## Device Facts - **Applicant:** Aalto Scientific, Ltd. - **Product Code:** [GGN](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN.md) - **Decision Date:** Jun 23, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.5425 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use The Audit™ MicroCV™ D-Dimer Linearity Set is a quantitative, assayed quality control material consisting of five levels of D-dimer analyte. The five D-dimer levels demonstrate a linear relationship to each other for D-dimer analyte. The Audit™ MicroCV™ D-Dimer Linearity Set is intended to use with the Biomerieux miniVIDAS® analyzer and VIDAS® D-dimer assay to verify the calibration of the measuring range. Audit™ MicroCV™ D-Dimer Linearity Set is "For In Vitro Diagnostic Use Only." ## Device Story Audit™ MicroCV™ D-Dimer Linearity Set is a human-based, lyophilized, five-level quality control material; contains D-Dimer complex. Used in clinical laboratory settings to verify calibration, linear operating range, and reportable range of Biomerieux miniVIDAS® analyzer and VIDAS® D-dimer assay. Levels A through E are related by linear dilution; Level A represents the lower limit and Level E represents the upper limit of the instrument's measuring range. Healthcare providers use the output to confirm instrument performance and ensure accuracy of patient D-Dimer test results. Benefits include improved confidence in diagnostic accuracy for coagulation testing. ## Clinical Evidence No clinical data. Bench testing only. Stability studies performed to determine reconstituted stability (2 days at 2-8° C) and shelf life (2 years at 2-8° C). ## Technological Characteristics Human-based, lyophilized, five-level quality control material. Analyte: D-Dimer complex. Form factor: Vials for reconstitution. Storage: 2-8° C. Intended for use with Biomerieux miniVIDAS® analyzer. ## Regulatory Identification A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays. ## Special Controls *Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. ## Predicate Devices - Triage® D-dimer Calibration Verification Controls (k050799) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k100716 B. Purpose for Submission: Clearance of a new device C. Measurand: D-dimer D. Type of Test: Quantitative E. Applicant: Aalto Scientific, Ltd. F. Proprietary and Established Names: Audit™ MicroCV™ D-Dimer Linearity Set G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425 2. Classification: Class II 3. Product code: GGN-Plasma, Coagulation Control 4. Panel: 81 (Hematology) H. Intended Use: 1. Intended use(s): The Audit™ MicroCV™ D-Dimer Linearity Set is a quantitative, assayed quality control material consisting of five levels of D-dimer analyte. The five D-dimer levels demonstrate a linear relationship to each other for D-dimer analyte. The Audit™ MicroCV™ D-Dimer Linearity Set is intended to use with the Biomerieux miniVIDAS® analyzer and VIDAS® D-dimer assay to verify the calibration of the measuring range. Audit™ MicroCV™ D-Dimer Linearity Set is "For In Vitro Diagnostic Use Only." 2. Indication(s) for use: Same as intended use(s) 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Biomerieux miniVIDAS® analyzer and VIDAS® D-dimer assay I. Device Description: The Audit™ MicroCV™ D-Dimer Linearity Set is a human based, lyophilized, five level set of QC material, A, B, C, D, and E. Each level contains D-dimer complex. It is used to confirm the proper calibration of the measuring range of D-dimer on the miniVIDAS® analyzer. Level A D-dimer is near the lower limit level and level E D-dimer is near the upper limit of the measuring range. Levels B, C, and D are related by linear dilution of level A and level E. The target ranges for five levels are: {1} 2 | Levels | A | B | C | D | E | | --- | --- | --- | --- | --- | --- | | Target Range | <150 ng/mL | 1105-1495 ng/mL | 2010-2760 ng/mL | 2145-4255 ng/mL | 3700-6000 ng/mL | ## J. Substantial Equivalence Information: 1. Predicate device name(s): Triage® D-dimer Calibration Verification Controls 2. Predicate K number(s): k050799 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device: Audit™ MicroCV™ D-Dimer Linearity Set | Predicate: Triage® D-dimer Calibration Verification Controls | | Intended Use | The Audit™ MicroCV™ D-Dimer Linearity Set is a quantitative, assayed quality control material consisting of five levels of D-dimer analyte. The five D-dimer levels demonstrate a linear relationship to each other for D-dimer analyte. The Audit™ MicroCV™ D-Dimer Linearity Set is intended to use with the Biomerieux miniVIDAS® analyzer and VIDAS® D-dimer assay to verify the calibration of the measuring range. | The Triage® D-dimer Calibration Verification Controls are to be used with the Triage® D-dimer Test and Triage® MeterPlus to verify the calibration of the Triage® D-dimer test throughout the measurable range. The Triage® D-dimer Calibration Verification Controls are assayed materials to be used with the Triage® D-dimer Test and Triage® MeterPlus to assist the laboratory in monitoring test performance. | | Number of levels per set | 5 | Same | | Matrix | Human based plasma | Same | | Differences | | | | --- | --- | --- | | Item | | | | Matrix | Lyophilized | Liquid | | Closed vial stability | 2-8°C for 24 months | -20°C for 9 months | | Open vial stability | 2 days when stored at 2-8°C | 1 day when stored at 2-8°C | ## K. Standard/Guidance Document Referenced (if applicable): CLSI EP06-A: Evaluation of Linearity of Quantitative Measurement Procedures: A Statistical Approach. ## L. Test Principle: The Audit™ MicroCV™ D-Dimer Linearity Set is used to verify the calibration of the D-dimer measuring range of the miniVIDAS® analyzer. ## M. Performance Characteristics: 1. Analytical performance: a. Precision/Reproducibility: {2} For each level of D-Dimer Linearity Set, 15 replicates were tested on the miniVIDAS® on three lots. All levels resulted <10% CV. b. Linearity/assay reportable range: Linearity was determined using three lots of the D-Dimer Linearity Set. The mean D-dimer concentration of each of the 5 levels was plotted vs. five assigned levels of concentration. A linear regression value was obtained for each lot, and all results were within the limit of acceptance r² > 0.95. c. Traceability, Stability, Expected values (controls, calibrators, or methods): - Traceability: All reagent components are obtained from commercial vendors. - Open vial stability: A 2-day open vial stability claim was verified using three lots of the Audit™ MicroCV™ D-Dimer Linearity Set. All 5 levels were tested on day zero and day 2. The percent recovery is determined in comparison to day zero values. The percent recovery is within ±10% limit of acceptance. - Closed vial stability: An accelerated stability is used to predict shelf life. The vials are stressed at 25°C for 64 days to predict two-year stability when stored at 2-8°C. The percent recovery of all levels is determined in comparison to day zero values and the product is considered stable when the recovered values are within ±10%. Real time studies are ongoing to support the shelf life of the product. - Value assignment: For each level of D-Dimer Linearity Set, 15 separate vials were tested on one miniVIDAS® analyzer yielding 15 measurements. The mean of each level was used to calculate the target concentration. The target range of each level was calculated as ±1SD of the target concentration. d. Detection limit: Not applicable e. Analytical specificity: Not applicable f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: Not applicable b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable {3} 5. Expected values/Reference range: The mean and expected assay range for each level are provided in the labeling. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 4 --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K100716](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K100716) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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