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

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 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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## DEC - 7 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.

#### K040427 K042723 510(k) Number:

#### A. Name and Address of Submitter

| Company Name: | Biosite Incorporated |
|------------------------|---------------------------------------------|
| Address: | 11030 Roselle Street<br>San Diego, CA 92121 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Jeffrey R. Dahlen, Ph.D. |
| Date Summary Prepared: | 9/30/04 |

#### 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® Profiler S.O.B. Panel (K040437) K 04-2 7 2 3

#### 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 1, B-type natriuretic peptide, and cross-linked fibrin dearadation 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.

#### E. Summary of Comparison Data

There have been no changes to the test performance, design, reagents and manufacture. These are identical to 510(k) document number K040437. The indications for use have been revised for clarity.

#### F. Conclusion

The revision to the indications for use raises no new issues of safety and effectiveness for the Triage Profiler S.O.B. Panel. Because there were no modifications to the test performance, design, reagents and manufacture, the test system is substantially equivalent to the predicate method.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three lines representing snakes intertwined around a staff.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 7 2004

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

Re: k042723

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, MMI, JHX, DDR, NBC Dated: September 30, 2004 Received: October 1, 2004

Dear Dr. Dahlen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 can be found in Title 21, Code of Federal 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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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This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotest notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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, rr you stions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation 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 Division of Small Manufacturers, 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,

Cornelia B. Lorkes

Cornelia B. Rooks, MA Acting 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): IBO K042723

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 pentide, 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.

Prescription Use

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

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

Carol C. Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042723