Cleared Traditional

K964372 - CARDIAC T TROPONIN T RAPID ASSAY

K964372 is an FDA 510(k) clearance for CARDIAC T TROPONIN T RAPID ASSAY, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code MMI cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K964372 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
101d
Days
Class 2
Risk

K964372 is an FDA 510(k) clearance for the CARDIAC T TROPONIN T RAPID ASSAY. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K964372

510(k) Number K964372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date February 10, 1997
Days to Decision 101 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
13d slower than avg
Panel avg: 88d · This submission: 101d
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 71
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K964372.
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
TROPONIN-I TEST SYSTEM
K964862 · Dade Intl., Inc. · 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