Cleared Traditional

K772014 - AMES T-4 STRIP TEST

K772014 is an FDA 510(k) clearance for AMES T-4 STRIP TEST, manufactured by Miles Laboratories, Inc.. The device is a Class 2 Immunology device with product code CDX cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K772014 · Miles Laboratories, Inc. · Immunology device
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Nov 1977
Decision
8d
Days
Class 2
Risk

K772014 is an FDA 510(k) clearance for the AMES T-4 STRIP TEST. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1977 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1700 - the FDA immunology device 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

FDA 510(k) Submission Details - K772014

510(k) Number K772014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1977
Decision Date November 02, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 105d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDX Device Classification - Class 2, Special Controls

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 Immunology devices follow this clearance model.

Regulatory Peers - CDX Radioimmunoassay, Total Thyroxine

All 93
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K772014.
EMIT CENTRIFICHEM THYROXINE ASSAY
K772170 · Syva Co. · Dec 1977
PEDIATRIC THYROXINE TEST SYS. T4
K771609 · Corning Medical & Scientific · Dec 1977
IN VITRO DIAGNOSTIC REAGENT
K772096 · Pcl-Ria, Inc. · Nov 1977
T4 RIA TEST SYSTEM
K771221 · Monobind · Aug 1977
RIA FOR TOTAL THYROXINE
K771309 · Abbott Laboratories · Aug 1977
QUANTIMUNE NEONATAL & THYROXINE RIA
K771135 · Bio-Rad · Jul 1977