Cleared Traditional

K781181 - CLINIRIA TOTAL T-4 (RIA) TEST

K781181 is an FDA 510(k) clearance for CLINIRIA TOTAL T-4 (RIA) TEST, manufactured by Miles Laboratories, Inc.. The device is a Class 2 Chemistry device with product code CDX cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K781181 · Miles Laboratories, Inc. · Chemistry device
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Aug 1978
Decision
31d
Days
Class 2
Risk

K781181 is an FDA 510(k) clearance for the CLINIRIA TOTAL T-4 (RIA) 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 August 14, 1978 after a review of 31 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 Miles Laboratories, Inc. devices

FDA 510(k) Submission Details - K781181

510(k) Number K781181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1978
Decision Date August 14, 1978
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 Chemistry 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 K781181.
RIA KIT, GAMMACOAT
K782109 · Clinical Assays, Inc. · Jan 1979
ACCUSCREEN T4
K781222 · Neometrics, Inc. · Nov 1978
ORTHO*T-4 RIA (PEG) KIT
K781483 · Ortho Diagnostics, Inc. · Sep 1978
MICRO THYROXINE REAGENT SYSTEM
K781182 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978
IV VITRO GAMMADAB T4 RIA KIT
K781235 · Clinical Assays, Inc. · Aug 1978
IN VITRO NEONATAL T4
K780854 · Clinical Assays, Inc. · Jul 1978