Cleared Traditional

K771222 - TSH RIA TEST SYSTEM

K771222 is the FDA 510(k) clearance for TSH RIA TEST SYSTEM by Monobind. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K771222 · Monobind · Chemistry device
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Aug 1977
Decision
30d
Days
Class 2
Risk

K771222 is an FDA 510(k) clearance for the TSH RIA TEST SYSTEM. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Monobind (Mchenry, US). The FDA issued a Cleared decision on August 4, 1977 after a review of 30 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.

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Submission Details

510(k) Number K771222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1977
Decision Date August 04, 1977
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
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 148
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K771222.
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
TSH RADIOIMMUNOASSAY
K770892 · Kallestad Laboratories, Inc. · Jun 1977
CLASP RIA KIT, HTSH
K770915 · E. R. Squibb & Sons, Inc. · Jun 1977