Cleared Traditional

K800911 - A-GENT THYROZYME UPTAKE INHIBITOR ASSAY

K800911 is an FDA 510(k) clearance for A-GENT THYROZYME UPTAKE INHIBITOR ASSAY, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code KHQ cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K800911 · Abbott Laboratories · Chemistry device
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Jun 1980
Decision
60d
Days
Class 2
Risk

K800911 is an FDA 510(k) clearance for the A-GENT THYROZYME UPTAKE INHIBITOR ASSAY. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 20, 1980 after a review of 60 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K800911

510(k) Number K800911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1980
Decision Date June 20, 1980
Days to Decision 60 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
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHQ Device Classification - Class 2, Special Controls

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 64
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K800911.
OREAI-Q-TU TEST
K802464 · Organon, Inc. · Oct 1980
T3 UPTAKE TEST SYSTEM
K802468 · American Diagnostic Corp. · Oct 1980
ANALYTE T3 UPTAKE
K802246 · Technicon Instruments Corp. · Oct 1980
VENTRE/SEP T3 UPTAKE RADIOASSAY
K800165 · Ventrex Laboratories, Inc. · Feb 1980
AMES RIALYZE - UPTAKE CHROM. TUBES
K800170 · Miles Laboratories, Inc. · Feb 1980
AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM
K792662 · Micromedic Systems · Jan 1980