Cleared Traditional

K991177 - OPUS TROPONIN I (CTN) TEST MODULES

K991177 is the FDA 510(k) clearance for OPUS TROPONIN I (CTN) TEST MODULES by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code MMI) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K991177 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
85d
Days
Class 2
Risk

K991177 is an FDA 510(k) clearance for the OPUS TROPONIN I (CTN) TEST MODULES. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 1, 1999 after a review of 85 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 Behring, Inc. devices

Submission Details

510(k) Number K991177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1999
Decision Date July 01, 1999
Days to Decision 85 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
3d faster than avg
Panel avg: 88d · This submission: 85d
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 62
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K991177.
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY
K993309 · Bayer Corp. · Dec 1999
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)
K993353 · Bayer Corp. · Dec 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
K992366 · Ortho-Clinical Diagnostics, Inc. · Oct 1999
IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
K991795 · Diagnostic Products Corp. · Jun 1999
STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK
K984093 · Dade Behring, Inc. · Dec 1998
ELECSYS TROPONIN T STAT TEST
K984105 · Boehringer Mannheim Corp. · Dec 1998