Cleared Traditional

K935816 - VIDAS T UPTAKE

K935816 is the FDA 510(k) clearance for VIDAS T UPTAKE by Biomerieux Vitek, Inc.. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K935816 · Biomerieux Vitek, Inc. · Chemistry device
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Mar 1994
Decision
110d
Days
Class 2
Risk

K935816 is an FDA 510(k) clearance for the VIDAS T UPTAKE. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on March 22, 1994 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1715 - 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 K935816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1993
Decision Date March 22, 1994
Days to Decision 110 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
22d slower than avg
Panel avg: 88d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHQ Radioassay, Triiodothyronine Uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1715
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 - KHQ Radioassay, Triiodothyronine Uptake

All 53
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K935816.
T-UPTAKE EIA TEST
K951586 · Diagnostic Reagents, Inc. · May 1995
STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY
K933414 · Baxter Diagnostics, Inc. · Nov 1994
AXSYM(TM) T-UPTAKE
K934312 · Abbott Laboratories · Jun 1994
T3 UPTAKE CHEMILUMINESCENCE ASSAY
K926220 · Nichols Institute Diagnostics · Nov 1993
COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS
K926443 · Roche Diagnostic Systems, Inc. · May 1993
CIBA CORNING ACS T UPTAKE IMMUNOASSAY
K925257 · Ciba Corning Diagnostics Corp. · Dec 1992