Cleared Traditional

K981882 - CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST

K981882 is an FDA 510(k) clearance for CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN..., manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Chemistry device with product code MMI cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K981882 · Princeton BioMeditech Corp. · Chemistry device
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Jul 1998
Decision
39d
Days
Class 2
Risk

K981882 is an FDA 510(k) clearance for the CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on July 6, 1998 after a review of 39 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 Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K981882

510(k) Number K981882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1998
Decision Date July 06, 1998
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
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 90
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K981882.
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
IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15
K983972 · Diagnostic Products Corp. · Dec 1998
STRATUS CS CARDIAC TROPONIN I TESTPAK
K981098 · Dade Behring, Inc. · Apr 1998
CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
K980528 · Chiron Diagnostics Corp. · Mar 1998
ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT
K974839 · First Medical, Inc. · Feb 1998