TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS

K050799 · Biosite Incorporated · GGN · Jun 29, 2005 · Hematology

Device Facts

• Record ID: K050799
• Device Name: TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS
• Applicant: Biosite Incorporated
• Product Code: GGN · Hematology
• Decision Date: Jun 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

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 Controls are assayed materials to be used with the Triage D-Dimer Test and Triage MeterPlus to assist the laboratory in monitoring test performance.

Device Story

Triage D-Dimer Calibration Verification Controls and Triage D-Dimer Controls are liquid quality control materials; composed of EDTA human plasma with preservatives and D-dimer; used with Triage D-Dimer Test and Triage MeterPlus. Calibration verification controls supplied in five levels (A-E); Triage D-Dimer Controls supplied in two levels (1-2). Laboratory personnel use these assayed materials to monitor test performance and verify calibration throughout the measurable range. Product stability maintained at -20 °C or colder.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid control material; EDTA human plasma base with preservatives and D-dimer; stored at -20 °C. Designed for use with Triage MeterPlus. No electronic or software components; purely chemical/biological control material.

Indications for Use

Indicated for use by laboratory professionals as assayed quality control materials to verify calibration and monitor performance of the Triage D-Dimer Test when used with the Triage MeterPlus system.

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

• Bio-Rad Liquichek™ D-dimer Control Levels 1, 2 and 3 (k032017)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
K050799

B. Purpose for Submission:
To obtain clearance for the Triage® D-Dimer Calibration Verification Controls and the Triage® D-Dimer Controls

C. Measurand:
D-dimer

D. Type of Test:
Quality Control

E. Applicant:
Biosite Incorporated

F. Proprietary and Established Names:
Triage® D-Dimer Calibration Verification Controls
Triage® D-Dimer Controls

G. Regulatory Information:
1. Regulation section:
21 CFR 864.5425
2. Classification:
Class II
3. Product code:
GGN

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4. Panel:
81 Hematology

H. Intended Use:

1. Intended use(s):
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 Controls are assayed materials to be used with the Triage D-Dimer Test and Triage Meter Plus to assist the laboratory in monitoring test performance.

2. Indication(s) for use:
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 Controls are assayed materials to be used with the Triage D-Dimer Test and Triage Meter Plus to assist the laboratory in monitoring test performance.

3. Special conditions for use statement(s):

4. Special instrument requirements:
Triage MeterPlus

I. Device Description:
The Triage D-Dimer Calibration Verification Controls are supplied as five 0.25 mL vials at levels A, B, C, D, and E. Each vial is composed of EDTA human plasma containing preservatives and D-dimer. The concentrations and standard deviations are on the enclosed card.

The Triage D-Dimer Controls are supplied as five 0.25 mL vials at two levels (1 and 2). The vials are composed of EDTA human plasma containing preservatives and D-dimer.

J. Substantial Equivalence Information:

1. Predicate device name(s):

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Bio-Rad Liquichek™ D-dimer Control Levels 1, 2 and 3

2. Predicate 510(k) number(s):

K032017

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes | D-dimer | Same |
| Form | Liquid | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Assayed control for monitoring test performance | Assayed quality control to monitor the precision of D-dimer procedures |
| Matrix | EDTA human plasma containing preservative and D-dimer | Processed human plasma with added constituents of human and animal origin and preservatives |
| Storage (unopened) | -20 °C or colder | 2-8 °C until expiration date |

K. Standard/Guidance Document Referenced (if applicable):

None referenced

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The Triage D-Dimer Calibration Verification Controls and Triage D-Dimer Controls were prepared using EDTA plasma at various concentrations. The Level 1 and Level 2 Controls were tested 8 times each at 10 different time

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points using the Triage D-Dimer Controls. The % CV for the Level 1 control is 8.6% and the Level 2 control is 8.2%.

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

An open vial stability study was conducted to determine the stability of the control material once removed from frozen storage. Samples were thawed on a bench top with an ambient room temperature of 22 °C. Samples were tested on the same lot of randomized Triage devices at 10, 15, 20, 30, 60, 90 and 120 minutes. Samples were tested on 6 devices at each time point. Acceptance criterion for the study was defined as D-dimer values being within the expected range ± 2 standard deviations. Acceptable performance was obtained when the controls were thawed between 10-120 minutes with 30 minutes being the recommended time point for a thawed vial.

Closed-vial stability studies are continual and are used to determine product expiration dating. The Triage D-Dimer Calibration Verification Controls and the Triage D-Dimer Controls were stored at -20 °C and data generated over the initial 9 months indicated that D-dimer present in the Triage D-Dimer Calibration Verification Controls and the Triage D-Dimer Controls are stable for at least 9 months at -20 °C.

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:

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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):

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Lot specific

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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