Cleared Traditional

K780672 - 125 I-T4 RIA REAGENT

K780672 is an FDA 510(k) clearance for 125 I-T4 RIA REAGENT, manufactured by Radioimmunoassay, Inc.. The device is a Class 2 Chemistry device with product code CDX cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K780672 · Radioimmunoassay, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1978
Decision
43d
Days
Class 2
Risk

K780672 is an FDA 510(k) clearance for the 125 I-T4 RIA REAGENT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Radioimmunoassay, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 6, 1978 after a review of 43 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 Radioimmunoassay, Inc. devices

FDA 510(k) Submission Details - K780672

510(k) Number K780672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1978
Decision Date June 06, 1978
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
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 94
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K780672.
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
EMIT CENTRIFICHEM THYROXINE ASSAY
K780639 · Syva Co. · May 1978
RADIOASSAY FOR TOTAL SERUM THYROXINE
K780644 · Nuclear Diagnostics, Inc. · Apr 1978
THYRO-ZYME-T4 ASSAY KIT
K780401 · Coulter Electronics, Inc. · Apr 1978