Cleared Traditional

K780726 - TSH RIA KIT

K780726 is the FDA 510(k) clearance for 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 41-day FDA review.

K780726 · Amersham Corp. · Chemistry device
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Jun 1978
Decision
41d
Days
Class 2
Risk

K780726 is an FDA 510(k) clearance for the 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 June 13, 1978 after a review of 41 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 K780726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1978
Decision Date June 13, 1978
Days to Decision 41 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
47d faster than avg
Panel avg: 88d · This submission: 41d
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 K780726.
RIA KIT, IMMO PHASE
K781953 · Corning Medical & Scientific · Feb 1979
IMMO PHASE, THYROID HORMONE
K781409 · Corning Medical & Scientific · Sep 1978
QUANTIMUNE HTSH IRMA HUMAN THYROID
K781170 · Bio-Rad · Aug 1978
ROCHE TSH RIA
K780428 · Hoffmann-La Roche, Inc. · Mar 1978
RABBIT ANTIBODY/THYROID STIMUL. HORMONE
K780059 · Pcl-Ria, Inc. · Feb 1978
THYROID STIMULATING HORMONE
K780015 · Pcl-Ria, Inc. · Feb 1978