Cleared Traditional

K022946 - LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST

K022946 is an FDA 510(k) clearance for LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST, 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 34-day FDA review.

K022946 · Princeton BioMeditech Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
34d
Days
Class 2
Risk

K022946 is an FDA 510(k) clearance for the LIFESIGN MI 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 October 8, 2002 after a review of 34 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 - K022946

510(k) Number K022946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2002
Decision Date October 08, 2002
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 K022946.
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
K031031 · Ortho-Clinical Diagnostics, Inc. · Sep 2003
VIDAS TROPONIN I (TNI), MODEL 30 445
K030950 · bioMerieux, Inc. · Jun 2003
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS
K024193 · Ortho-Clinical Diagnostics · Feb 2003
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345
K021814 · Beckman Coulter, Inc. · Sep 2002
MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS
K020662 · Ortho-Clinical Diagnostics · Apr 2002
AIA-PACK CTNI 2ND-GEN ASSAY
K012820 · Tosoh Medics, Inc. · Dec 2001