Cleared Traditional

K973126 - TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I

K973126 is an FDA 510(k) clearance for TRIAGE CARDIAC PANEL, manufactured by Biosite Incorporated. The device is a Class 2 Chemistry device with product code JHX cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K973126 · Biosite Incorporated · Chemistry device
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Oct 1997
Decision
47d
Days
Class 2
Risk

K973126 is an FDA 510(k) clearance for the TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIA.... Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on October 6, 1997 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biosite Incorporated devices

FDA 510(k) Submission Details - K973126

510(k) Number K973126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1997
Decision Date October 06, 1997
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHX Device Classification - Class 2, Special Controls

Product Code JHX Fluorometric Method, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JHX Fluorometric Method, Cpk Or Isoenzymes

All 41
Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K973126.
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
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STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK
K981099 · Dade Behring, Inc. · May 1998
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K980012 · Ac Biochemicals, Inc. · Feb 1998
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K972782 · Dade Intl., Inc. · Aug 1997
VIDAS CREATINE KINASE MB ASSAY 30-421
K962549 · Biomerieux Vitek, Inc. · Aug 1996
MYDAS(TM)-MB2/MYDAS(TM)-MB
K913380 · Intl. Immunoassay Laboratories, Inc. · Apr 1992