Cleared Traditional

K781235 - IV VITRO GAMMADAB T4 RIA KIT

K781235 is an FDA 510(k) clearance for IV VITRO GAMMADAB T4 RIA KIT, manufactured by Clinical Assays, Inc.. The device is a Class 2 Immunology device with product code CDX cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K781235 · Clinical Assays, Inc. · Immunology device
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Aug 1978
Decision
26d
Days
Class 2
Risk

K781235 is an FDA 510(k) clearance for the IV VITRO GAMMADAB T4 RIA KIT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978 after a review of 26 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 Clinical Assays, Inc. devices

FDA 510(k) Submission Details - K781235

510(k) Number K781235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1978
Decision Date August 14, 1978
Days to Decision 26 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
79d faster than avg
Panel avg: 105d · This submission: 26d
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 K781235.
ORTHO*T-4 RIA (PEG) KIT
K781483 · Ortho Diagnostics, Inc. · Sep 1978
CLINIRIA TOTAL T-4 (RIA) TEST
K781181 · Miles Laboratories, Inc. · Aug 1978
MICRO THYROXINE REAGENT SYSTEM
K781182 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978
IN VITRO NEONATAL T4
K780854 · Clinical Assays, Inc. · Jul 1978
EMIT CENTRIFICHEM THYROXINE ASSAY
K780639 · Syva Co. · May 1978
RADIOASSAY FOR TOTAL SERUM THYROXINE
K780644 · Nuclear Diagnostics, Inc. · Apr 1978