Cleared Traditional

K771234 - TSH RIA REAGENT SET

K771234 is an FDA 510(k) clearance for TSH RIA REAGENT SET, manufactured by G.D. Searle and Co.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 99-day FDA review.

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

FDA 510(k) Submission Details - K771234

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
Combination Product No
PCCP Authorized No
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.

JLW Device Classification - Class 2, Special Controls

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 K771234.
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
HTSH RIA HUMAN THYROID HORMONE RIA
K771235 · Abbott Laboratories · Aug 1977
TSH RADIOIMMUNOASSAY
K770892 · Kallestad Laboratories, Inc. · Jun 1977
CLASP RIA KIT, HTSH
K770915 · E. R. Squibb & Sons, Inc. · Jun 1977