Cleared Traditional

K781481 - ORTHO*T-3 RIA (PEG) KIT

K781481 is the FDA 510(k) clearance for ORTHO*T-3 RIA (PEG) KIT by Ortho Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K781481 · Ortho Diagnostics, Inc. · Chemistry device
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Sep 1978
Decision
30d
Days
Class 2
Risk

K781481 is an FDA 510(k) clearance for the ORTHO*T-3 RIA (PEG) KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Ortho Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1978 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 Ortho Diagnostics, Inc. devices

Submission Details

510(k) Number K781481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1978
Decision Date September 27, 1978
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Chemistry devices follow this clearance model.

Regulatory Peers - CDP Radioimmunoassay, Total Triiodothyronine

All 101
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K781481.
QUANTIMUNE T-3 FIA
K790960 · Bio-Rad · Aug 1979
RIA, TEST SET CENTRIA T3
K790908 · Ventrex Laboratories, Inc. · Jun 1979
CHROMATOGRAPHY TUBES
K790581 · Miles Laboratories, Inc. · May 1979
RABBIT ANTIBODY TO HUMAN T3
K781284 · Pcl-Ria, Inc. · Aug 1978
TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT
K780787 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1978
T3 RIA
K771623 · Hoffmann-La Roche, Inc. · Sep 1977