Cleared Traditional

K033487 - STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI

K033487 is an FDA 510(k) clearance for STRATUS CS ACUTE CARE TROPONIN I TESTPAK, manufactured by Dade Behring, Inc.. The device is a Class 2 Chemistry device with product code MMI cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K033487 · Dade Behring, Inc. · Chemistry device
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Dec 2003
Decision
50d
Days
Class 2
Risk

K033487 is an FDA 510(k) clearance for the STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI. 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 December 24, 2003 after a review of 50 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

FDA 510(k) Submission Details - K033487

510(k) Number K033487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2003
Decision Date December 24, 2003
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
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 78
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K033487.
ABBOTT AXSYM TROPONIN-I ADV
K041811 · Abbott Laboratories · Sep 2004
ARCHITECT STAT TROPONIN-I IMMUNOASSAY
K041192 · Fisher Diagnostics · Aug 2004
ELECSYS TROPONIN T STAT TEST
K040733 · Roche Diagnostics Corp. · May 2004
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