Cleared Traditional

K862968 - FREE T3 RADIOIMMUNOASSAY KIT

K862968 is the FDA 510(k) clearance for FREE T3 RADIOIMMUNOASSAY KIT by Bioclinical Group. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

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 59
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K862968.
IMMUBEAD THYROID UPTAKE
K872172 · Immunotech Corp. · Aug 1987
AFFINITY(TM) I UPTAKE IMMUNIT(TM)
K865083 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1987
CIBA CORNING MAGIC(R) LITE TU IMMUNOASSAY
K864132 · Ciba Corning Diagnostics Corp. · Dec 1986
MMS T3 UPTAKE
K861262 · Micromedic Systems · May 1986
STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY
K860422 · American Dade · Apr 1986
TERUMO SENSIBEAD EIA THYROID UPTAKE KIT
K842694 · Terumo Medical Corp. · Sep 1984