Cleared Traditional

K833703 - ACA THYROXINE UPTAKE ANALYTICAL TEST

K833703 is the FDA 510(k) clearance for ACA THYROXINE UPTAKE ANALYTICAL TEST by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K833703 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry device
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Jan 1984
Decision
104d
Days
Class 2
Risk

K833703 is an FDA 510(k) clearance for the ACA THYROXINE UPTAKE ANALYTICAL TEST. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 104 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K833703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1983
Decision Date January 30, 1984
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 88d · This submission: 104d
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 K833703.
STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY
K860422 · American Dade · Apr 1986
TERUMO SENSIBEAD EIA THYROID UPTAKE KIT
K842694 · Terumo Medical Corp. · Sep 1984
STRATUS THYROID UPTAKE FLUOROMETRIC
K834209 · American Dade · Mar 1984
MAGIC TM 125I T3 UPTAKE RADIOASSAY
K831613 · Corning Medical & Scientific · Aug 1983
TDX T-UPTAKE
K830912 · Abbott Laboratories · Apr 1983
ADVANCE TM T-3 UPTAKE ASSAY
K822592 · Syva Co. · Oct 1982