Cleared Traditional

K973650 - TROPONIN (TROP) METHOD

K973650 is an FDA 510(k) clearance for TROPONIN (TROP) METHOD, manufactured by Dade Chemistry Systems, Inc.. The device is a Class 2 Chemistry device with product code MMI cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K973650 · Dade Chemistry Systems, Inc. · Chemistry device
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Oct 1997
Decision
25d
Days
Class 2
Risk

K973650 is an FDA 510(k) clearance for the TROPONIN (TROP) METHOD. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Dade Chemistry Systems, Inc. (Glasgow, US). The FDA issued a Cleared decision on October 20, 1997 after a review of 25 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 Dade Chemistry Systems, Inc. devices

FDA 510(k) Submission Details - K973650

510(k) Number K973650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1997
Decision Date October 20, 1997
Days to Decision 25 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
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMI Device Classification - Class 2, Special Controls

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 76
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K973650.
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
TARGET CARDIAC TROPONIN I TEST
K972094 · Texas Immunology, Inc. · Jul 1997
CARDIAC T TROPONIN T RAPID ASSAY
K964372 · Boehringer Mannheim Corp. · Feb 1997
TROPONIN-I TEST SYSTEM
K964862 · Dade Intl., Inc. · Feb 1997