Cleared Traditional

K780292 - TRIA-PEG RIA DIAG. KIT

K780292 is an FDA 510(k) clearance for TRIA-PEG RIA DIAG. KIT, manufactured by Nuclear Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code CDP cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K780292 · Nuclear Diagnostics, Inc. · Toxicology device
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Mar 1978
Decision
9d
Days
Class 2
Risk

K780292 is an FDA 510(k) clearance for the TRIA-PEG RIA DIAG. KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Nuclear Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1978 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1710 - 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 - K780292

510(k) Number K780292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1978
Decision Date March 02, 1978
Days to Decision 9 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 87d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDP Device Classification - Class 2, Special Controls

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 114
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K780292.
ORTHO*T-3 RIA (PEG) KIT
K781481 · Ortho Diagnostics, Inc. · Sep 1978
RABBIT ANTIBODY TO HUMAN T3
K781284 · Pcl-Ria, Inc. · Aug 1978
TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT
K780787 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1978
TRI-TAB-RIA
K772177 · Nuclear Medical Laboratories, Inc. · Dec 1977
IN VITRO T3 RIA TEST
K772108 · Clinical Assays, Inc. · Nov 1977
T3 RIA
K771623 · Hoffmann-La Roche, Inc. · Sep 1977