TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5

K072892 · Biosite Incorporated · JJY · Dec 7, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072892
• Device Name: TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
• Applicant: Biosite Incorporated
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Triage® Total Controls 5 are assayed materials to be used with the Triage® Profiler S.O.B.™ Panel, Triage® CardioProfilER® Panel, Triage Cardiac Panel, Triage® BNP Test, Triage® D-Dimer Test and the Triage Meters to assist in monitoring test performance. The Triage® Total Calibration Verification 5 are assayed materials to be used with the Triage® Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage® Cardiac Panel, Triage® BNP Test, Triage® D-Dimer Test and the Triage Meters to verify the calibration of the Test Devices throughout the measurable range.

Device Story

Triage® Total Controls 5 and Calibration Verification 5 are single-use, liquid quality control materials; composed of concentrated purified CK-MB, myoglobin, troponin I, BNP, and D-Dimer in human EDTA plasma. Used in clinical settings with Triage Meters (MeterPlus® and MeterPro®) to monitor test performance and verify calibration across the measurable range. Materials are stored frozen at ≤ -20°C. Healthcare providers use these to ensure accuracy of diagnostic test devices; results assist in clinical decision-making by validating that the Triage system is operating within established performance specifications.

Clinical Evidence

No clinical data. Bench testing only. Stability testing confirmed recovery within 80-120% acceptance criteria at ≤ -20°C. Traceability established to in-house purified and analyzed antigens.

Technological Characteristics

Materials: Purified CK-MB, myoglobin, troponin I, BNP, D-Dimer in human EDTA plasma. Form factor: 0.29 mL unit dose liquid. Storage: ≤ -20°C. Connectivity: None (manual use with Triage Meters).

Indications for Use

Indicated for use as assayed quality control and calibration verification materials for Triage test systems (Profiler S.O.B., CardioProfilER, Cardiac Panel, BNP, D-Dimer) on Triage Meters to monitor performance and verify calibration range.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Triage® Profiler S.O.B. (Shortness of Breath) Controls and the Triage® Profiler S.O.B. Calibration Verification Controls (K040459)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k072892

B. Purpose for Submission:
New devices: Triage® Total Controls 5 and Triage® Total Calibration Verification 5

C. Measurand:
Control and calibrator verification material for test systems containing CK-MB, Myoglobin, Troponin I, β-type natriuretic peptide (BNP), and D-Dimer

D. Type of Test:
Control materials

E. Applicant:
Biosite Incorporated

F. Proprietary and Established Names:
Triage® Total Controls 5
Triage® Total Calibration Verification 5

G. Regulatory Information:
1. Regulation section:
21 CFR§862.1660
2. Classification:
Class I, reserved
3. Product code:
JJY

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4. Panel:
Clinical Chemistry (75)

H. Intended Use:

1. Intended use(s):
See indication for use

2. Indication(s) for use:
The Triage® Total Controls 5 are assayed materials to be used with the Triage® Profiler S.O.B.™ Panel, Triage® CardioProfilER® Panel, Triage Cardiac Panel, Triage® BNP Test, Triage® D-Dimer Test and the Triage Meters to assist in monitoring test performance.

The Triage® Total Calibration Verification 5 are assayed materials to be used with the Triage® Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage® Cardiac Panel, Triage® BNP Test, Triage® D-Dimer Test and the Triage Meters to verify the calibration of the Test Devices throughout the measurable range.

3. Special conditions for use statement(s):
Prescription Use

4. Special instrument requirements:
Triage MeterPlus® and Triage MeterPro®

I. Device Description:
The Triage® Total Control 5 Controls 1 and 2, and the Triage® Total Calibration Verification 5 Levels A, B, C, D, E are single-use 0.29 mL unit dose quality control materials prepared with concentrated purified CK-MB, myoglobin, troponin I, BNP and D-Dimer and human EDTA plasma at defined levels. The human plasma material has been tested for hepatitis B surface antigen, antibodies to hepatitis C, and antibodies against human immunodeficiency virus. The controls are stored frozen at < -20°C. Preservatives and stabilizers are added to maintain product integrity.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Triage® Profiler S.O.B. (Shortness of Breath) Controls

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Triage® Profiler S.O.B. Calibration Verification Controls

2. Predicate K number(s):

k040459

3. Comparison with predicate:

| Similarities-Triage® Total Controls 5 | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | The Triage Total Controls are assayed materials to be used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to assist in monitoring test performance. | Same |
| Form | Liquid | Same |
| Analytes | CK-MB, myoglobin, Troponin I, BNP, D-Dimer | Same |
| Storage (unopened) | ≤ -20°C | Same |
| Matrix | EDTA Human Plasma | Same |
| Room Temp claim | 30 minutes | Same |
| Levels | 2 | Same |
| Differences - Triage® Total Controls 5 | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Packaging | 0.29 mL polystyrene unit-dose vial | 3.0 mL polypropylene vial |
| Similarities - Triage® Total Calibration Verification 5 | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The Triage Total Calibration Verification 5 materials are to be used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and Triage Meters to verify the calibration of the Test Devices throughout the measurable range. | Same |
| Form | Liquid | Same |
| Analytes | CK-MB, myoglobin, Troponin I, BNP, D-Dimer | Same |
| Storage (unopened) | ≤ -20°C | Same |
| Matrix | EDTA Human Plasma | Same |
| Room Temp claim | 30 minutes | Same |
| Levels | 5 | Same |

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| Differences - Triage® Total Calibration Verification 5 | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Packaging | 0.29 mL polystyrene unit-dose vial | 3.0 mL polypropylene vial |

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

No standard/guidance documents were referenced.

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

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

Traceability

The materials are traceable to in-house purified, and analyzed antigens.

Stability

Closed vial stability was performed at ≤ -20°C. The devices are single use products. Recovery at all time points tested was within sponsor’s acceptance criteria of 80-120%.

Expected values

Values assigned to the controls are obtained from multiple runs of Triage® Total Calibration Verification 5 and Triage® Total Controls 5 on multiple device lots over several days.

d. Detection limit:

Not applicable

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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):

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

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.