Cleared Traditional

K952478 - BOEHRINGER MANNHEIM CARDIAC T TROPONIN ...

K952478 is an FDA 510(k) clearance for BOEHRINGER MANNHEIM CARDIAC T TROPONIN ..., 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 163-day FDA review.

K952478 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
163d
Days
Class 2
Risk

K952478 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM 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 November 9, 1995 after a review of 163 days - an extended review 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: 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 - K952478

510(k) Number K952478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1995
Decision Date November 09, 1995
Days to Decision 163 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
75d slower than avg
Panel avg: 88d · This submission: 163d
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 K952478.
ELECSYS TROPONIN T
K961500 · Boehringer Mannheim Corp. · Jun 1996
BOEHRINGER MANNHEIM CARDIAC T TROPNIN T
K955868 · Boehringer Mannheim Corp. · Feb 1996
OPUS TROPONIN I
K955284 · Behring Diagnostics, Inc. · Jan 1996
STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS
K951890 · Dade Intl., Inc. · Jul 1995
CARDIAC T ELISA TROPONIN-T
K924392 · Boehringer Mannheim Corp. · Apr 1994