Cleared Traditional

RIA KIT, NEONATAL T4 (K782103) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K782103 · Serono Laboratories, Inc. · Chemistry device
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Jan 1979
Decision
33d
Days
Class 2
Risk

K782103 is an FDA 510(k) clearance for the RIA KIT, NEONATAL T4. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Serono Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1979 after a review of 33 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 Serono Laboratories, Inc. devices

Submission Details

510(k) Number K782103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1978
Decision Date January 17, 1979
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 88d · This submission: 33d
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 Chemistry devices follow this clearance model.

Regulatory Peers - CDX Radioimmunoassay, Total Thyroxine

All 27
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K782103.
RIA PHASE T4
K800203 · Boehringer Mannheim Corp. · Mar 1980
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
K792188 · Abbott Laboratories · Nov 1979
QUANTIMUNE T-4 FIA
K790576 · Bio-Rad · Jul 1979
MICRO THYROXINE REAGENT SYSTEM
K781182 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978
EMIT CENTRIFICHEM THYROXINE ASSAY
K780639 · Syva Co. · May 1978
REAGENTS, MANUEAL, ASSAY, THYROXINE
K780121 · Syva Co. · Mar 1978