AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5

K100716 · Aalto Scientific, Ltd. · GGN · Jun 23, 2011 · Hematology

Device Facts

• Record ID: K100716
• Device Name: AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
• Applicant: Aalto Scientific, Ltd.
• Product Code: GGN · Hematology
• Decision Date: Jun 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

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. 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.

Indications for Use

Indicated for use as a quantitative, assayed quality control material to verify the calibration and measuring range of the Biomerieux miniVIDAS® analyzer and VIDAS® D-dimer assay. For in vitro diagnostic use only.

Regulatory Classification

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)

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# 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:

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| 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:

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For each level of D-Dimer Linearity Set, 15 replicates were tested on the miniVIDAS® on three lots. All levels resulted &lt;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 &gt; 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

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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.

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