Cleared Traditional

K973616 - TROPONIN I ASSAY FOR THE BAYER IMMUNO 1...

K973616 is the FDA 510(k) clearance for TROPONIN I ASSAY FOR THE BAYER IMMUNO 1... by Bayer Corp.. It is a Class 2 Chemistry device (product code MMI) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K973616 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
73d
Days
Class 2
Risk

K973616 is an FDA 510(k) clearance for the TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 5, 1997 after a review of 73 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 Bayer Corp. devices

Submission Details

510(k) Number K973616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1997
Decision Date December 05, 1997
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 88d · This submission: 73d
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 68
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K973616.
CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST
K981882 · Princeton BioMeditech Corp. · Jul 1998
STRATUS CS CARDIAC TROPONIN I TESTPAK
K981098 · Dade Behring, Inc. · Apr 1998
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
K974818 · Radiometer America, Inc. · Jan 1998
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