TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300

K042723 · Biosite Incorporated · DAP · Dec 7, 2004 · Hematology

Device Facts

• Record ID: K042723
• Device Name: TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
• Applicant: Biosite Incorporated
• Product Code: DAP · Hematology
• Decision Date: Dec 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Indications for Use

The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism, and an aid in the risk stratification of patients with acute coronary syndromes.

Device Story

Triage® Profiler S.O.B. Panel; quantitative fluorescence immunoassay; uses Triage® Meter Plus. Input: EDTA whole blood or plasma specimens. Process: sample added to device port; cells separated via filter; plasma reacts with fluorescent antibody conjugates; reaction mixture flows down detection lane; analyte-conjugate complexes captured on discrete zones. Output: fluorescence intensity proportional to analyte concentration (CK-MB, myoglobin, troponin I, BNP, D-dimer). Used in clinical settings; operated by healthcare professionals. Output aids diagnosis of myocardial infarction, heart failure, thromboembolic events, and risk stratification for acute coronary syndromes.

Clinical Evidence

No new clinical data provided. Performance characteristics, including analytical sensitivity, specificity, precision, and method comparison, rely on data previously established for the predicate device (k040437).

Technological Characteristics

Fluorescence immunoassay; uses murine monoclonal and polyclonal antibodies for CK-MB, myoglobin, troponin I, BNP, and D-dimer. Solid-phase capture zones; fluorescent dye labeling. Dimensions/form factor: test device with integrated filter and reaction chamber. Instrument: Triage® Meter Plus. Anticoagulant: EDTA.

Indications for Use

Indicated for patients suspected of having myocardial infarction, heart failure, disseminated intravascular coagulation, or thromboembolic events including pulmonary embolism, and for risk stratification of patients with acute coronary syndromes.

Predicate Devices

• Triage® Profiler S.O.B. Panel (k040437)

Submission Summary (Full Text)

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

A. 510(k) Number:
k042723

B. Purpose for Submission:
Modification to Indications for Use of Triage® Profiler S.O.B. Panel (k040437). The sponsor has modified the portion of the Indications for Use statement pertaining to the D-Dimer test from: “...an aid in the assessment and evaluation of patients suspected of disseminated intravascular coagulation (including pulmonary embolism) and other non-specific thromboembolic events...” to “...an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.” The change was made for clarification of the language and to agree with the wording in the Indications for Use statement for the Triage® D-Dimer Test (k042890), cleared November 29, 2004.

C. Analyte:
D-Dimer
CK-MB
Troponin I
Myoglobin
BNP

D. Type of Test:
Quantitative fluorescence immunoassay

E. Applicant:
Biosite Incorporated

F. Proprietary and Established Names:
Triage® Profiler S.O.B. Panel

G. Regulatory Information:
1. Regulation section:
21 CFR 864.7320, Fibrinogen/fibrin degradation products assay
21 CFR 862.1215, Immunoassay Method, Troponin Subunit
21 CFR 862.1215, Fluorometric method, CPK or isoenzymes
21 CFR 866.5680, Myoglobin, antigen, antiserum, control
21 CFR 862.1117, Test, Natriuretic Peptide
2. Classification:
Class II

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3. Product Code: DAP, MMI, JHX, DDR, NBC

4. Panel: 81 Hematology, 75 Chemistry, 82 Immunology

## H. Intended Use:

1. Intended use(s): The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism, and an aid in the risk stratification of patients with acute coronary syndromes.

2. Indication(s) for use: See Intended Use above

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

4. Special instrument Requirements: Triage® Meter Plus

## I. Device Description:

The Triage® Profiler S.O.B. Test Device contains all the reagents necessary for the simultaneous quantification of D-dimer, CK-MB, myoglobin, troponin I, and BNP in plasma and whole blood. The test device contains murine monoclonal and polyclonal antibodies against CK-MB, murine monoclonal and polyclonal antibodies against myoglobin, murine monoclonal and goat polyclonal antibodies against troponin I, murine monoclonal antibodies to D-dimer, and murine monoclonal and polyclonal antibodies against BNP labeled with a fluorescent dye and immobilized on the solid phase, and stabilizers.

## J. Substantial Equivalence Information:

1. Predicate device name(s): Triage® Profiler S.O.B. Panel

2. Predicate K number(s): k040437

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Principle | Fluorescence immunoassay | Same |
| Instrument | Triage® Meter Plus | Same |
| Differences | | |
| Item | Device | Predicate |
| Indications for Use | The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism, and an aid in the risk stratification of patients with acute coronary syndromes. | The Triage® Profiler S.O.B. (Shortness of Breath) Panel is a fluorescence immunoassay to be used with the Triage® Meter Plus for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the assessment and evaluation of patients suspected of disseminated intravascular coagulation (including pulmonary embolism) and other non-specific thromboembolic events, and an aid in the risk stratification of patients with acute coronary syndromes. |

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K. Standard/Guidance Document Referenced (if applicable):
None referenced

L. Test Principle:
The Triage® Profiler S.O.B. Test Device contains all the reagents necessary for the simultaneous quantification of the cardiac proteins D-dimer, CK-MB, myoglobin, troponin I, and BNP in whole blood and plasma specimens using EDTA as the anticoagulant. After addition of the sample to the sample port, the cells are separated from the plasma via a filter contained in the device. A predetermined quantity of plasma is allowed to react with fluorescent antibody conjugates within the reaction chamber. After sufficient incubation has occurred, the reaction mixture flows down the device detection lane. Complexes of the analytes and fluorescent antibody conjugates are captured on discrete zones resulting in binding assays that are specific for each analyte. The concentration of the analyte in the specimen is directly proportional to the fluorescence detected.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
See k040437
b. Linearity/assay reportable range:
See k040437
c. Traceability (controls, calibrators, or method):
The Triage® Profiler S.O.B. Panel has been standardized using purified protein preparations of D-dimer, CK-MB, myoglobin, troponin I, and BNP based on the mass (concentration) of analyte present in EDTA-anticoagulated plasma.
d. Detection limit:
See k040437.
e. Analytical specificity:
See k040437
f. Assay cut-off:
See k040437

2. Comparison studies:
a. Method comparison with predicate device:
See k040437
b. Matrix comparison:
See k040437

3. Clinical studies:
a. Clinical sensitivity:
See k040437
b. Clinical specificity:
See k040437
c. Other clinical supportive data (when a and b are not applicable

4. Clinical cut-off:
See k040437

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5. Expected values/Reference range: See k040437

**N. Conclusion:**
The submitted material in this premarket notification is complete and supports a substantial equivalence decision.

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