Cleared Traditional

K860422 - STRAT THYROID UPTAKE FLUROMET ENZYME IM...

K860422 is the FDA 510(k) clearance for STRAT THYROID UPTAKE FLUROMET ENZYME IM... by American Dade. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K860422 · American Dade · Chemistry device
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Apr 1986
Decision
66d
Days
Class 2
Risk

K860422 is an FDA 510(k) clearance for the STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on April 11, 1986 after a review of 66 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 American Dade devices

Submission Details

510(k) Number K860422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1986
Decision Date April 11, 1986
Days to Decision 66 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
22d faster than avg
Panel avg: 88d · This submission: 66d
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 K860422.
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
TERUMO SENSIBEAD EIA THYROID UPTAKE KIT
K842694 · Terumo Medical Corp. · Sep 1984
STRATUS THYROID UPTAKE FLUOROMETRIC
K834209 · American Dade · Mar 1984
ACA THYROXINE UPTAKE ANALYTICAL TEST
K833703 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1984