Cleared Traditional

K772109 - IN VITRO HUMAN TSH RIA TEST

K772109 is the FDA 510(k) clearance for IN VITRO HUMAN TSH RIA TEST by Clinical Assays, Inc.. It is a Class 2 Immunology device (product code JLW) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K772109 · Clinical Assays, Inc. · Immunology device
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Dec 1977
Decision
29d
Days
Class 2
Risk

K772109 is an FDA 510(k) clearance for the IN VITRO HUMAN TSH RIA TEST. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1977 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1690 - the FDA immunology device 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 Clinical Assays, Inc. devices

Submission Details

510(k) Number K772109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1977
Decision Date December 06, 1977
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 104d · This submission: 29d
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 Immunology devices follow this clearance model.

Regulatory Peers - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 155
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K772109.
RABBIT ANTIBODY/THYROID STIMUL. HORMONE
K780059 · Pcl-Ria, Inc. · Feb 1978
THYROID STIMULATING HORMONE
K780015 · Pcl-Ria, Inc. · Feb 1978
NEONATAL TSH RIA KIT (125I)
K772192 · Diagnostic Products Corp. · Jan 1978
SERALUTE TSH (RIA)
K771767 · Miles Laboratories, Inc. · Oct 1977
TSH RIA REAGENT SET
K771234 · G.D. Searle and Co. · Oct 1977
HTSH RIA HUMAN THYROID HORMONE RIA
K771235 · Abbott Laboratories · Aug 1977