Cleared Traditional

K780639 - EMIT CENTRIFICHEM THYROXINE ASSAY

K780639 is the FDA 510(k) clearance for EMIT CENTRIFICHEM THYROXINE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code CDX) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K780639 · Syva Co. · Toxicology device
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May 1978
Decision
16d
Days
Class 2
Risk

K780639 is an FDA 510(k) clearance for the EMIT CENTRIFICHEM THYROXINE ASSAY. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on May 3, 1978 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1700 - the FDA toxicology 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 Syva Co. devices

Submission Details

510(k) Number K780639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1978
Decision Date May 03, 1978
Days to Decision 16 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 87d · This submission: 16d
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 Toxicology devices follow this clearance model.

Regulatory Peers - CDX Radioimmunoassay, Total Thyroxine

All 68
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K780639.
NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM
K790665 · Micromedic Systems · May 1979
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
THYRO-ZYME-T4 ASSAY KIT
K780401 · Coulter Electronics, Inc. · Apr 1978
OREIA-T4
K780308 · Organon, Inc. · Apr 1978
REAGENTS, MANUEAL, ASSAY, THYROXINE
K780121 · Syva Co. · Mar 1978