Cleared Traditional

K964862 - TROPONIN-I TEST SYSTEM

K964862 is the FDA 510(k) clearance for TROPONIN-I TEST SYSTEM by Dade Intl., Inc.. It is a Class 2 Chemistry device (product code MMI) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K964862 · Dade Intl., Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 1997
Decision
68d
Days
Class 2
Risk

K964862 is an FDA 510(k) clearance for the TROPONIN-I TEST SYSTEM. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Dade Intl., Inc. (Miami, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 68 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 Intl., Inc. devices

Submission Details

510(k) Number K964862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1996
Decision Date February 10, 1997
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
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 69
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K964862.
ABBOTT AXSYM TROPONIN-I
K974103 · Abbott Laboratories · Nov 1997
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K974075 · Beckman Instruments, Inc. · Nov 1997
CARDIAC T TROPONIN T RAPID ASSAY
K964372 · Boehringer Mannheim Corp. · 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
ELECSYS TROPONIN T
K961500 · Boehringer Mannheim Corp. · Jun 1996