TRIAGE PROFILER S.O.B. PANEL

K040437 · Biosite Incorporated · DAP · Jun 25, 2004 · Hematology

Device Facts

• Record ID: K040437
• Device Name: TRIAGE PROFILER S.O.B. PANEL
• Applicant: Biosite Incorporated
• Product Code: DAP · Hematology
• Decision Date: Jun 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2

Intended 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 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.

Device Story

Triage® Profiler S.O.B. Panel is a fluorescence immunoassay used with Triage® Meter Plus; provides quantitative measurement of CK-MB, myoglobin, troponin I, BNP, and D-dimer. Device processes EDTA whole blood or plasma samples; utilizes fluorescence immunoassay technology to detect specific cardiac and thromboembolic markers. Designed for clinical use to assist physicians in diagnosing myocardial infarction, assessing heart failure severity, evaluating suspected disseminated intravascular coagulation/pulmonary embolism, and risk-stratifying acute coronary syndrome patients. Output displayed on Triage Meter Plus; aids clinical decision-making by providing rapid diagnostic data for patients presenting with shortness of breath.

Clinical Evidence

Bench testing only. Method comparison performed for CK-MB, troponin I, myoglobin, and BNP against predicate methods, demonstrating equivalence. D-dimer assay evaluated using 180 specimens; Passing-Bablok regression analysis yielded slope of 0.999, intercept of -85.89, and correlation coefficient of 0.92.

Technological Characteristics

Fluorescence immunoassay; quantitative detection of CK-MB, myoglobin, troponin I, BNP, and D-dimer. Designed for use with Triage® Meter Plus. Analyzes EDTA whole blood or plasma specimens.

Indications for Use

Indicated for patients suspected of myocardial infarction, heart failure, disseminated intravascular coagulation (including pulmonary embolism), other thromboembolic events, or acute coronary syndromes requiring risk stratification. Uses EDTA whole blood or plasma specimens.

Predicate Devices

• Triage® Cardiac Panel (k973126)
• Triage® B-Type Natriuretic Peptide (BNP) Test (k021317)
• Stratus CS DDMR TestPak (k022976)

Submission Summary (Full Text)

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## JUN 2 5 2004

## 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### K040437 510(k) Number:

#### A. Name and Address of Submitter

| Company Name: | Biosite Incorporated |
|------------------------|--------------------------|
| Address: | 11030 Roselle Street |
| | San Diego, CA 92121 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Jeffrey R. Dahlen, Ph.D. |
| Date Summary Prepared: | 6/24/04 |

#### B. Device Names

- 1. Trade Name
Triage® Profiler S.O.B. Panel

- 2. Common / Usual Name
Triage® Profiler S.O.B. Panel

#### 3. Classification Name

Fluorometric Method, CPK or Isoenzymes (862.1215) Product Code JHX

Immunoassay Method, Troponin Subunit (862.1215) Product Code MMI

Myoglobin, Antigen, Antiserum, Control (866.5680) Product Code DDR

Test, Natriuretic Peptide (862.1117) Product Code NBC

Fibrinogen/Fibrin Degradation Products Assay (864.7320) Product Code GHH

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## C. Predicate Devices

Triage® Cardiac Panel (K973126) Triage® BNP Test (K021317) Dade Behring Stratus CS DDMR TestPak (K022976)

#### D. Device Description and Intended 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 (iniury), 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.

## E. Summary of Comparison Data

A method comparison of the CK-MB, troponin I, myoglobin, and BNP assays demonstrated that the assays on the Triage Profiler S.O.B. panel are equivalent to the same assays in the predicate methods. A method comparison of D-dimer results was performed using 180 specimens throughout the measurable range of the test. A Passing-Bablok regression analysis of the results yielded a linear relationship with a slope of 0.999, an intercept of -85.89 and a correlation coefficient of 0.92. The analytical performance characteristics for each of the assays were equivalent with the predicate methods.

## F. Conclusion

The assays on the Triage Profiler S.O.B. Panel are substantially equivalent to the predicate methods. The evaluation has led to assurance that the Triage Profiler S.O.B. Panel is safe and effective for the intended use and no new issues of safety and effectiveness have been raised.

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Public Health Service

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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JUN 2 5 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jeffrey R. Dahlen, Ph.D. Director, Clinical & Regulatory Affairs Biosite Incorporated 11030 Roselle Street San Diego, CA 92121

k040437 Re:

Trade/Device Name: Triage® Profiler S.O.B. Panel Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/Fibrin degradation products assay Regulatory Class: Class II Product Code: DAP, NBC,MMI, JHX, DDR Dated: June 1, 2004 Received: June 2, 2004

Dear Dr. Dahlen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreas, 1976, the enactment date of the Medical Device Amendments, or to conimered pror to may 20, 2017 11:11 accordance with the provisions of the Federal Food, Drug, de necs that have been recuire approval of a premarket approval application (PMA). and Coometer fore, market the device, subject to the general controls provisions of the Act. The I va may, therefore, mains of the Act include requirements for annual registration, listing of general controls proficturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device it may be subject to bach additions beend Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr has Intatutes and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms loter will and in your of substantial equivalence of your device of your device to a legally prematication: "The Blassification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, II you desire spoolitie niemand advertising of your device, please contact the Office of of questions on the promotion and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain other getterers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, U.S., Div.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K040437

Device Name: Triage® Profiler S.O.B. Panel

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 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.

| Prescription Use | |
|------------------|--|
|------------------|--|

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson

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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040437

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