Cleared Traditional

K771767 - SERALUTE TSH (RIA)

K771767 is the FDA 510(k) clearance for SERALUTE TSH (RIA) by Miles Laboratories, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K771767 · Miles Laboratories, Inc. · Chemistry device
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Oct 1977
Decision
36d
Days
Class 2
Risk

K771767 is an FDA 510(k) clearance for the SERALUTE TSH (RIA). Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 25, 1977 after a review of 36 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K771767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1977
Decision Date October 25, 1977
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
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 143
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K771767.
TSH RIA KIT
K780726 · Amersham Corp. · Jun 1978
ROCHE TSH RIA
K780428 · Hoffmann-La Roche, Inc. · Mar 1978
NEONATAL TSH RIA KIT (125I)
K772192 · Diagnostic Products Corp. · Jan 1978
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