Cleared Traditional

K781284 - RABBIT ANTIBODY TO HUMAN T3

K781284 is an FDA 510(k) clearance for RABBIT ANTIBODY TO HUMAN T3, manufactured by Pcl-Ria, Inc.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K781284 · Pcl-Ria, Inc. · Chemistry device
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Aug 1978
Decision
36d
Days
Class 2
Risk

K781284 is an FDA 510(k) clearance for the RABBIT ANTIBODY TO HUMAN T3. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Pcl-Ria, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1978 after a review of 36 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 Pcl-Ria, Inc. devices

FDA 510(k) Submission Details - K781284

510(k) Number K781284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1978
Decision Date August 31, 1978
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
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 Chemistry devices follow this clearance model.

Regulatory Peers - CDP Radioimmunoassay, Total Triiodothyronine

All 118
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K781284.
RIA, TEST SET CENTRIA T3
K790908 · Ventrex Laboratories, Inc. · Jun 1979
CHROMATOGRAPHY TUBES
K790581 · Miles Laboratories, Inc. · May 1979
ORTHO*T-3 RIA (PEG) KIT
K781481 · Ortho Diagnostics, Inc. · Sep 1978
TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT
K780787 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1978
TRIA-PEG RIA DIAG. KIT
K780292 · Nuclear Diagnostics, Inc. · Mar 1978
TRI-TAB-RIA
K772177 · Nuclear Medical Laboratories, Inc. · Dec 1977