Cleared Traditional

K955284 - OPUS TROPONIN I

K955284 is the FDA 510(k) clearance for OPUS TROPONIN I by Behring Diagnostics, Inc.. It is a Class 2 Chemistry device (product code MMI) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K955284 · Behring Diagnostics, Inc. · Chemistry device
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Jan 1996
Decision
70d
Days
Class 2
Risk

K955284 is an FDA 510(k) clearance for the OPUS TROPONIN I. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on January 25, 1996 after a review of 70 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K955284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1995
Decision Date January 25, 1996
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
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 K955284.
CARDIAC STATUS TROPONIN I
K963513 · Princeton BioMeditech Corp. · Nov 1996
ELECSYS TROPONIN T
K961500 · Boehringer Mannheim Corp. · Jun 1996
BOEHRINGER MANNHEIM CARDIAC T TROPNIN T
K955868 · Boehringer Mannheim Corp. · Feb 1996
BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY
K952478 · Boehringer Mannheim Corp. · Nov 1995
CARDIAC T ELISA TROPONIN-T
K924392 · Boehringer Mannheim Corp. · Apr 1994