# K040437: Triage Profiler S.O.B. Panel

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jun 25, 2004 after 127 days
- Product code: DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 864.7320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K862156 (1986). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973126: Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin, Triage Troponin-I and CK-MB, Triage Troponin-I, Biosite Incorporated (1997) Summary page 2.
- K021317: Triage B-Type Natriuretic Peptide (BNP) Test, Biosite Incorporated (2002) Summary page 2.
- K022976: Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D, Dade Behring, Inc. (2003) Summary page 2.

## Most influential descendants
- K042723: Trigage Profiler S.O.B. Panel, Model 97300 (2004), 0 descendants of its own
- K042890: Triage D-Dimer Test, Model 98100 (2004), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K040437
Methodology: https://510kreport.com/methodology