Cleared Traditional

K030950 - VIDAS TROPONIN I (TNI), MODEL 30 445

K030950 is an FDA 510(k) clearance for VIDAS TROPONIN I (TNI), manufactured by bioMerieux, Inc.. The device is a Class 2 Chemistry device with product code MMI cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K030950 · bioMerieux, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
82d
Days
Class 2
Risk

K030950 is an FDA 510(k) clearance for the VIDAS TROPONIN I (TNI), MODEL 30 445. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on June 16, 2003 after a review of 82 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.

FDA 510(k) Submission Details - K030950

510(k) Number K030950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2003
Decision Date June 16, 2003
Days to Decision 82 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
7d faster than avg
Panel avg: 89d · This submission: 82d
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 94
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K030950.
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
I-STAT CARDIAC TROPONIN (CTNI) TEST
K031739 · I-Stat Corporation · Sep 2003
VBL SERUM TROPONIN I TEST, MODEL 1001
K023505 · Vancouver Biotech , Ltd. · Mar 2003
SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST
K030057 · Spectral Diagnostics, Inc. · Mar 2003
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS
K024193 · Ortho-Clinical Diagnostics · Feb 2003
K030950 · VIDAS TROPONIN I (TNI), MODEL 30 445
Download PDF FDA Summary bioMerieux, Inc.