Cleared Traditional

FREE T3 RADIOIMMUNOASSAY KIT (K862968) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862968 · Bioclinical Group · Chemistry device
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Sep 1986
Decision
50d
Days
Class 2
Risk

K862968 is an FDA 510(k) clearance for the FREE T3 RADIOIMMUNOASSAY KIT. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Bioclinical Group (Cambridge, US). The FDA issued a Cleared decision on September 25, 1986 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1715 - 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: 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 Bioclinical Group devices

Submission Details

510(k) Number K862968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1986
Decision Date September 25, 1986
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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 18
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K862968.
EMIT CONVENIENCE PACK: T-UPTAKE ASSAY
K881855 · Syva Co. · Jun 1988
EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO
K880619 · Syva Co. · Apr 1988
AFFINITY(TM) I UPTAKE IMMUNIT(TM)
K865083 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1987
ACA THYROXINE UPTAKE ANALYTICAL TEST
K833703 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1984
TDX T-UPTAKE
K830912 · Abbott Laboratories · Apr 1983
ADVANCE TM T-3 UPTAKE ASSAY
K822592 · Syva Co. · Oct 1982