Cleared Traditional

AMERLEX TSH RIA KIT (K812136) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K812136 · Amersham Corp. · Chemistry device
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Aug 1981
Decision
16d
Days
Class 2
Risk

K812136 is an FDA 510(k) clearance for the AMERLEX TSH RIA KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Amersham Corp. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981 after a review of 16 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 Amersham Corp. devices

Submission Details

510(k) Number K812136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1981
Decision Date August 13, 1981
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 88d · This submission: 16d
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 70
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K812136.
EPSILON TSH TEST KIT
K831972 · Beckman Instruments, Inc. · Sep 1983
HISH EIA DIAGNOSTIC KIT
K822827 · Abbott Laboratories · Oct 1982
QUANTIMUNE HTSH IRMA
K822291 · Bio-Rad · Aug 1982
TECHNICON STAR SYSTEM
K811431 · Technicon Instruments Corp. · Jun 1981
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