Cleared Traditional

K812136 - AMERLEX TSH RIA KIT

K812136 is the FDA 510(k) clearance for AMERLEX TSH RIA KIT by Amersham Corp.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K812136 · Amersham Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 156
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K812136.
MICROMEDIC HTSH RIA KIT
K813645 · Micromedic Systems · Jan 1982
IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY
K813525 · Micromedic Systems · Dec 1981
RADIOIMMUNOASSAY FOR HUMAN THYROID
K813392 · Leeco Diagnostics, Inc. · Dec 1981
TECHNICON STAR SYSTEM
K811431 · Technicon Instruments Corp. · Jun 1981
TSH RADIOIMMUNOASSAY KIT
K802467 · American Diagnostic Corp. · Oct 1980
VENTREX/SEP TSH TEST SET
K801560 · Ventrex Laboratories, Inc. · Aug 1980