TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET

K093032 · Biosite Incorporated · JJY · Nov 13, 2009 · Clinical Chemistry

Device Facts

• Record ID: K093032
• Device Name: TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
• Applicant: Biosite Incorporated
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Triage® Total 3 Controls are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance. The Triage® Total 3 Calibration Verification Set are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance

Device Story

Triage® Total 3 Controls and Calibration Verification Set are liquid/frozen human EDTA plasma-based quality control materials containing CKMB, cardiac troponin I, and BNP. Used in clinical laboratory settings to monitor performance of Triage® diagnostic test devices and the Triage® Meter. Materials are not calibrators; results do not impact patient care or clinical diagnosis. Laboratory personnel thaw and use materials to verify test system performance throughout the measurable range. Device serves as a quality assurance tool to ensure diagnostic test accuracy.

Clinical Evidence

Bench testing only. Precision/reproducibility study conducted over 20 days following CLSI EP5-A guidelines. Within-run and total precision CVs reported for BNP, CK-MB, and Troponin I at high and low concentrations. No clinical studies performed.

Technological Characteristics

Liquid quality control materials; matrix: EDTA human plasma; analytes: CK-MB, troponin complex, BNP; storage: ≤-20°C; packaging: 0.25 mL polystyrene unit-dose vials; single-use; non-reactive for HbsAg, anti-HCV, HIV-1/2.

Indications for Use

Indicated for use by laboratory personnel as assayed quality control materials to monitor the performance of Triage® Troponin I, BNP, Cardio2, and Cardio3 diagnostic tests and the Triage® Meter. Not for patient diagnosis or clinical decision-making.

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® Total 5 Controls and Calibration Verification Set (K072892)

Submission Summary (Full Text)

{0}

1

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

A. 510(k) Number:
k093032

B. Purpose for Submission:
New devices: Triage® Total 3 Controls (TC3) and Triage® Total 3 Calibration Verification Set

C. Measurand:
Control and calibrator verification materials for CK-MB, Troponin I, and β-type natriuretic peptide (BNP)

D. Type of Test:
Quality control materials

E. Applicant:
Biosite Incorporated

F. Proprietary and Established Names:
Triage® Total 3 Controls
Triage® Total 3 Calibration Verification

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJY | Class I, reserved | 21 CFR§862.1660 | Chemistry 75 |

H. Intended Use:

{1}

1. Intended use(s):

See indication for use below.

2. Indication(s) for use:

The Triage® Total 3 Controls are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.

The Triage® Total 3 Calibration Verification Set are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance

3. Special conditions for use statement(s):

Prescription Use

4. Special instrument requirements:

Triage® Meter

I. Device Description:

The Triage® Total 3 Controls consist of two levels, level 1 and level 2. The Triage® Total 3 Calibration Verification Set consists of 5 levels, Levels A, B, C, D, E. All are single-use, unit dose (approximately 0.25 ml) quality control materials prepared with concentrated purified CK-MB, troponin complex, and BNP in human EDTA plasma at defined levels. The controls are stored frozen < -20°C. Preservatives and stabilizers are added to maintain product integrity.

All human source materials used to produce this product have been tested for HbsAg, anti-HCV, HIV-1 and HIV-2 and found to be non-reactive by FDA licensed tests.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Triage® Total 5 Controls

Triage ® Total 5 Calibration Verification Set

2. Predicate K number (s):

k072892

{2}

3. Comparison with predicate:

| Similarities-Triage® Total Controls 3 | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The Triage Total 3 Controls are assayed materials to be used with the Triage Troponin I Test, BNP Test, Cardio2 panel and Cardio3 panel devices and the Triage meter to assist the end user in monitoring product performance. | 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 performance |
| Form | Liquid | Same |
| Analytes | CK-MB, Troponin I, BNP | CK-MB, myoglobin, Troponin I, BNP, D-dimer |
| Storage (Unopened) | ≤-20°C | Same |
| Matrix | EDTA Human Plasma | Same |
| Room Temp Claim | 30 minutes | Same |
| Levels | 2 | Same |
| Packaging | Approximately 0.25 mL polystyrene unit-dose vial | Same |
| Differences-Triage® Total Controls 3 | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Packaging/Labeling | Triage ® Total Controls 3 | Triage® Total Controls 5 |
| Similarities-Triage® Total 3 Calibration Verification | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The Triage Total 3 Calibration Verification are assayed materials to be used with the Triage Troponin I Test, Triage BNP Test, Triage Cardio2 Panel and the Triage Cardio 3 Panel devices and the Triage® meter to assist the end user in monitoring product performance. | 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 the Triage Meters to verify the calibration of the Test Devices throughout the measurable range. |
| Form | Liquid | Same |
| Analytes | CK-MB, Troponin I, BNP | CK-MB, myoglobin, Troponin I, BNP, D-dimer |

{3}

| Storage (unopened) | ≤ -20° C | Same |
| --- | --- | --- |
| Matrix | EDTA Human Plasma | Same |
| Room Temp Claim | 30 minutes | Same |
| Levels | 5 | Same |
| Differences-Triage® Total Calibration Verification 5 | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Packaging/Labeling | Triage® Total Calibration Verification 3 | Triage® Total 5 Calibration Verification |

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

FDA Guidance for Industry and FDA Staff: Assayed and Unassayed Quality Control Materials

Clinical and Laboratory Standards Institute guideline, EP5-A, Precision Performance of Quantitative Measurement Methods.

# L. Test Principle:

Not applicable

# M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The within run precision (CV) of the CK-MB, Troponin, and BNP assay was performed by assaying the Total 3 Controls (low and high levels) for 20 days. This testing was considered to be representative of the Triage® Total 3 Calibration Verification Set. The controls were tested as they represent samples with CK-MB, Troponin I, and BNP concentrations near the clinical decision points and within the affected ranges. CLSI guideline EP5A, Evaluation of Precision Performance of Quantitative Measurement Methods was used as a guideline in performing and evaluating these studies,

{4}

Precision Study

| Within Run CV | | | |
| --- | --- | --- | --- |
| | BNP (pg/mL) | CKMB (ng/mL) | Troponin (ng/mL) |
| High Sample (concentration) | 2433.595 pg/mL | 47.634 ng/mL | 2.828 ng/ml |
| SD | 346.993 | 5.643 | 0.2205 |
| %CV | 13.6% | 11.8% | 8.2% |
| Low sample (concentration) | 104.096 pg/ml | 7.632 ng/ml | 0.060 ng/ml |
| SD | 10.123 | 0.732 | 0.0106 |
| %CV | 9.5% | 10.1% | 15.6% |
| | | | |
| Total Precision CV | | | |
| | BNP | CKMB | Troponin |
| High Sample (concentration) | 2433.595pg/ml | 47.634 ng/ml | 2.828 ng/ml |
| SD | 355.446 | 5.829 | 0.2205 |
| %CV | 13.9% | 12.2% | 8.2% |
| Low Sample (concentration) | 104.096 pg/ml | 7.632 ng/ml | 0.060 ng/ml |
| SD | 10.131 | 0.743 | 0.0128 |
| %CV | 9.5% | 10.3% | 18.8% |

b. Linearity/assay reportable range:

Not applicable

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

Traceability

Traceability for Troponin I, BNP and CKMB are to in-house prepared materials.

Stability

Real time closed vial stability was performed at $\leq -20^{\circ}\mathrm{C}$. Recovery at all time points was acceptable for a stability of one month. The devices are single use products.

d. Detection limit:

Not applicable

{5}

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:
The expected values are assigned to the Triage® Total 3 Controls and the Triage® Calibration Verification set by assaying multiple vials of Triage® Total 3 Controls (TC3) and Triage® Total 3 Calibration Verification on 20 days using multiple Triage test devices. The observed mean is used to establish the expected value range which is the mean ±3 SD. The expected values of the Triage® Total 3 Controls (TC3) and Triage® Total 3 Calibration Verification Set are lot dependent and are listed on the Expected Values (EV) card for each level

In the labeling, the sponsor recommends that each laboratory establish their own acceptable ranges.

{6}

The following are examples for a lot specific material.

| Control | Expected Values | CKMB,ng/mL | Troponin I,ng/mL | BNP, pg/mL |
| --- | --- | --- | --- | --- |
| Control 1 | Range | 2.75 – 8.0 | 0.04 - 0.06 | 60.0 – 140.0 |
| Control 2 | Range | 32.9 – 47.0 | 2.0 - 4.00 | 1925 – 2750 |
| Cal Ver Level | Expected Values | CKMB,ng/ml | Troponin I,ng/ml | BNP, pg/mL |
| --- | --- | --- | --- | --- |
| Level A | Range | 1.0 - 3.0 | 0.013 - 0.030 | 10.0 - 36.5 |
| Level B | Range | 3.0 - 6.45 | 0.025 - 0.050 | 36.5 – 150 |
| Level C | Range | 20.0 - 37.1 | 0.50 - 2.00 | 1074 – 1994 |
| Level D | Range | 43.2 – 61.6 | 5.50 - 7.50 | 2300 – 3650 |
| Level E | Range | 62.6 – 80 | 8.00 – 10.0 | 3660 – 5000 |

# 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.