Cleared Traditional

K041192 - ARCHITECT STAT TROPONIN-I IMMUNOASSAY

K041192 is an FDA 510(k) clearance for ARCHITECT STAT TROPONIN-I IMMUNOASSAY, manufactured by Fisher Diagnostics. The device is a Class 2 Chemistry device with product code MMI cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K041192 · Fisher Diagnostics · Chemistry device
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Aug 2004
Decision
98d
Days
Class 2
Risk

K041192 is an FDA 510(k) clearance for the ARCHITECT STAT TROPONIN-I IMMUNOASSAY. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on August 12, 2004 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Fisher Diagnostics devices

FDA 510(k) Submission Details - K041192

510(k) Number K041192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2004
Decision Date August 12, 2004
Days to Decision 98 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
10d slower than avg
Panel avg: 88d · This submission: 98d
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 82
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K041192.
BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
K041619 · Biocheck, Inc. · Dec 2004
INSTANT-VIEW TROPONIN I TEST
K042227 · Alfa Scientific Designs, Inc. · Nov 2004
ABBOTT AXSYM TROPONIN-I ADV
K041811 · Abbott Laboratories · Sep 2004
ELECSYS TROPONIN T STAT TEST
K040733 · Roche Diagnostics Corp. · May 2004
STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
K033487 · Dade Behring, Inc. · Dec 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
K031031 · Ortho-Clinical Diagnostics, Inc. · Sep 2003