Cleared Traditional

K972094 - TARGET CARDIAC TROPONIN I TEST

K972094 is the FDA 510(k) clearance for TARGET CARDIAC TROPONIN I TEST by Texas Immunology, Inc.. It is a Class 2 Chemistry device (product code MMI) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K972094 · Texas Immunology, Inc. · Chemistry device
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Jul 1997
Decision
49d
Days
Class 2
Risk

K972094 is an FDA 510(k) clearance for the TARGET CARDIAC TROPONIN I TEST. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Texas Immunology, Inc. (Tyler, US). The FDA issued a Cleared decision on July 23, 1997 after a review of 49 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 Texas Immunology, Inc. devices

Submission Details

510(k) Number K972094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1997
Decision Date July 23, 1997
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MMI Immunoassay Method, Troponin Subunit
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 - MMI Immunoassay Method, Troponin Subunit

All 69
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K972094.
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K973616 · Bayer Corp. · Dec 1997
ABBOTT AXSYM TROPONIN-I
K974103 · Abbott Laboratories · Nov 1997
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K974075 · Beckman Instruments, Inc. · Nov 1997
CARDIAC T TROPONIN T RAPID ASSAY
K964372 · Boehringer Mannheim Corp. · Feb 1997
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329
K963934 · Bio-Rad Laboratories, Inc. · Dec 1996
CARDIAC STATUS TROPONIN I
K963513 · Princeton BioMeditech Corp. · Nov 1996