Cleared Traditional

K780423 - STIKSEP-T4 RIA KIT

K780423 is an FDA 510(k) clearance for STIKSEP-T4 RIA KIT, manufactured by Nuclear Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code CDX cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K780423 · Nuclear Diagnostics, Inc. · Toxicology device
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Mar 1978
Decision
14d
Days
Class 2
Risk

K780423 is an FDA 510(k) clearance for the STIKSEP-T4 RIA KIT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Nuclear Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1978 after a review of 14 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 Nuclear Diagnostics, Inc. devices

FDA 510(k) Submission Details - K780423

510(k) Number K780423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1978
Decision Date March 30, 1978
Days to Decision 14 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 87d · This submission: 14d
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 Toxicology 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 K780423.
RADIOASSAY FOR TOTAL SERUM THYROXINE
K780644 · Nuclear Diagnostics, Inc. · Apr 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
ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY
K780219 · Syva Co. · Mar 1978
THYROXINE STDS. IN HUMAN SERUM
K780050 · Pcl-Ria, Inc. · Feb 1978