Cleared Traditional

TIPSEP-T3U TRIIODOTHYRONINE UPTAKE (K792484) - FDA 510(k) Clearance

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

K792484 · Nuclear Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1979
Decision
24d
Days
Class 2
Risk

K792484 is an FDA 510(k) clearance for the TIPSEP-T3U TRIIODOTHYRONINE UPTAKE. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Nuclear Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1979 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1715 - 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

Submission Details

510(k) Number K792484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1979
Decision Date December 27, 1979
Days to Decision 24 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 87d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHQ Radioassay, Triiodothyronine Uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1715
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 - KHQ Radioassay, Triiodothyronine Uptake

All 26
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K792484.
ANALYTE T3 UPTAKE
K802246 · Technicon Instruments Corp. · Oct 1980
A-GENT THYROZYME UPTAKE INHIBITOR ASSAY
K800911 · Abbott Laboratories · Jun 1980
AMES RIALYZE - UPTAKE CHROM. TUBES
K800170 · Miles Laboratories, Inc. · Feb 1980
RIA, T3 UPTAKE SOLID PHASE
K781662 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1978
CLINIRIA T-3 UPTAKE TEST
K781180 · Miles Laboratories, Inc. · Aug 1978
REAGENT SYSTEM, ARIA II T3 UPTAKE
K780253 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1978