Cleared Traditional

K771606 - IMMUNOSPOT NEONATAL T4 TEST

K771606 is the FDA 510(k) clearance for IMMUNOSPOT NEONATAL T4 TEST by Meloy Laboratories, Inc.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K771606 · Meloy Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1977
Decision
24d
Days
Class 2
Risk

K771606 is an FDA 510(k) clearance for the IMMUNOSPOT NEONATAL T4 TEST. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Meloy Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 15, 1977 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 Meloy Laboratories, Inc. devices

Submission Details

510(k) Number K771606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1977
Decision Date September 15, 1977
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - CDX Radioimmunoassay, Total Thyroxine

All 72
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K771606.
EMIT CENTRIFICHEM THYROXINE ASSAY
K772170 · Syva Co. · Dec 1977
PEDIATRIC THYROXINE TEST SYS. T4
K771609 · Corning Medical & Scientific · Dec 1977
AMES T-4 STRIP TEST
K772014 · Miles Laboratories, Inc. · Nov 1977
RIA FOR TOTAL THYROXINE
K771309 · Abbott Laboratories · Aug 1977
QUANTIMUNE NEONATAL & THYROXINE RIA
K771135 · Bio-Rad · Jul 1977
REAGENT SYSTEM, THYROXINE, ARIA
K770733 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1977