Cleared Traditional

K934764 - VIDAS T3 ASSAY

K934764 is the FDA 510(k) clearance for VIDAS T3 ASSAY by Biomerieux Vitek, Inc.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K934764 · Biomerieux Vitek, Inc. · Chemistry device
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Mar 1994
Decision
169d
Days
Class 2
Risk

K934764 is an FDA 510(k) clearance for the VIDAS T3 ASSAY. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 22, 1994 after a review of 169 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K934764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1993
Decision Date March 22, 1994
Days to Decision 169 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
81d slower than avg
Panel avg: 88d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 91
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K934764.
ACCESS(R) TOTAL T3
K940833 · Bio-Rad Laboratories, Inc. · Sep 1994
AIA-PACK TT3 ASSAY
K936229 · Tosoh Medics, Inc. · Jul 1994
AXSYM TOTAL T3
K934517 · Abbott Laboratories · Jun 1994
COBAS(R) CORE T3 EIA
K932608 · Roche Diagnostic Systems, Inc. · Dec 1993
CIBA CORNING ACS FREE T3 IMMUNOASSAY
K932747 · Ciba Corning Diagnostics Corp. · Dec 1993
MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT
K925436 · Medix Biotech, Inc. · Dec 1992