Triage Profiler S.O.B. Panel

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K040437 ↗

FDA Product Code

DAP

Device Class

Class II

Regulation

21 CFR Part 864.7320

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Biosite Triage Panel For Drugs Of Abuse (50NG/ML)

  Class II

  FDA 510(k) K931598 Active Cleared 12 May 1993

• Triage Cardiac Panel, Triage Troponin-I, Triage Ck-Mb, Triage Myoglobin, Triage Troponin-I and Ck-Mb, Triage Troponin-I

  Class II

  FDA 510(k) K973126 Active Cleared 6 Oct 1997

• Modification to Triage B-Type Natriuretic Peptide (Bnp) Test

  Class II

  FDA 510(k) K032235 Active Cleared 28 Jan 2004

• One Step Eddp (Methadone Metabolite) Test Strip

  Class II

  FDA 510(k) K092048 Active Cleared 19 Apr 2010

• Biosite Diagnostics Opiate Screening Test

  Class II

  FDA 510(k) K902924 Active Cleared 14 Sep 1990

• Triage Tox Drug Screen, Catalog #94000

  Class II

  FDA 510(k) K012745 Active Cleared 10 Jan 2002

See all devices from Biosite Incorporated →

• What conditions does the Triage Profiler S.O.B. Panel help evaluate?

  The panel measures biomarkers linked to cardiac ischemia or heart failure, such as creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and D-dimer. These markers help clinicians assess shortness of breath (S.O.B.) by distinguishing between cardiac and non-cardiac causes, enabling faster diagnostic decisions in acute care settings.

• How is the Triage Profiler S.O.B. Panel supplied and used?

  The panel is supplied as a single-use device designed exclusively for use with the Triage Meter Plus reader. Each panel contains reagents for simultaneous quantitative measurement of five biomarkers in EDTA whole blood or plasma. It is intended for point-of-care testing, allowing rapid results within minutes of specimen application.

• Is sterility or reprocessing required for this panel?

  The Triage Profiler S.O.B. Panel is a single-use device and is not intended for reprocessing or reuse. Sterility is maintained through its sealed packaging, ensuring each panel is sterile for one-time diagnostic use only. Reuse could compromise assay integrity and patient safety.

• What storage and handling precautions must be followed?

  Storage follows standard immunoassay protocols to preserve assay integrity. Panels should be stored at 2–30°C (35–86°F) and protected from light and moisture. Avoid freezing, as it may degrade reagents. Once opened, the panel must be used immediately with the Triage Meter Plus to prevent contamination or performance degradation.

• What regulatory pathway was used for FDA clearance?

  The Triage Profiler S.O.B. Panel received FDA 510(k) clearance through the Traditional pathway, demonstrating substantial equivalence to a predicate device. The clearance was assigned K-number K040437 and falls under product code DAP (Diagnostic Aids, Chemistry) for Class 2 Chemistry devices, ensuring compliance with FDA regulations for diagnostic testing.