Cleared Traditional

K802467 - TSH RADIOIMMUNOASSAY KIT

K802467 is the FDA 510(k) clearance for TSH RADIOIMMUNOASSAY KIT by American Diagnostic Corp.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K802467 · American Diagnostic Corp. · Chemistry device
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Oct 1980
Decision
22d
Days
Class 2
Risk

K802467 is an FDA 510(k) clearance for the TSH RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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 Diagnostic Corp. devices

Submission Details

510(k) Number K802467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1980
Decision Date October 31, 1980
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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 - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 106
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K802467.
QUANTIMUNE HTSH IRMA
K822291 · Bio-Rad · Aug 1982
AMERLEX TSH RIA KIT
K812136 · Amersham Corp. · Aug 1981
TECHNICON STAR SYSTEM
K811431 · Technicon Instruments Corp. · Jun 1981
VENTREX/SEP TSH TEST SET
K801560 · Ventrex Laboratories, Inc. · Aug 1980
HUMAN THYROID STIM. HORMONE/ARIA II
K800798 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980
HTSH NEONATE RIA DIAGNOSTIC KIT
K791747 · Abbott Laboratories · Nov 1979