Cleared Traditional

TSH RIA REAGENT SET (K771234) - FDA 510(k) Clearance

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

K771234 · G.D. Searle and Co. · Chemistry device
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Oct 1977
Decision
99d
Days
Class 2
Risk

K771234 is an FDA 510(k) clearance for the TSH RIA REAGENT SET. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1977 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all G.D. Searle and Co. devices

Submission Details

510(k) Number K771234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1977
Decision Date October 18, 1977
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 88d · This submission: 99d
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 K771234.
QUANTIMUNE HTSH IRMA HUMAN THYROID
K781170 · Bio-Rad · Aug 1978
NEONATAL TSH RIA KIT (125I)
K772192 · Diagnostic Products Corp. · Jan 1978
SERALUTE TSH (RIA)
K771767 · Miles Laboratories, Inc. · Oct 1977
HTSH RIA HUMAN THYROID HORMONE RIA
K771235 · Abbott Laboratories · Aug 1977
TSH RIA KIT
K760801 · Diagnostic Products Corp. · Nov 1976
KIT, RIA, HUMAN THYROID HORMONE
K760044 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1976