Cleared Traditional

K810717 - COAT-A-COUNT T3 UPTAKE KIT

K810717 is the FDA 510(k) clearance for COAT-A-COUNT T3 UPTAKE KIT by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code KHQ) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K810717 · Diagnostic Products Corp. · Chemistry device
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Mar 1981
Decision
14d
Days
Class 2
Risk

K810717 is an FDA 510(k) clearance for the COAT-A-COUNT T3 UPTAKE KIT. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1981 after a review of 14 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K810717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1981
Decision Date March 31, 1981
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
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 46
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K810717.
LEECO T3% DIAGNOSTIC KIT
K822575 · Leeco Diagnostics, Inc. · Sep 1982
T3 UPTAKE DIAGNOSTIC KIT
K821722 · Diagnostic Reagents, Inc. · Jun 1982
ENZYME-TEST TBC T4 UPTAKE
K820879 · Icl Scientific · Apr 1982
IMMU-TRACE T3 UPTAKE (T3U) REAGENTS
K803044 · American Dade · Jan 1981
ANALYTE T3 UPTAKE
K802246 · Technicon Instruments Corp. · Oct 1980
A-GENT THYROZYME UPTAKE INHIBITOR ASSAY
K800911 · Abbott Laboratories · Jun 1980