Cleared Traditional

K780787 - TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT

K780787 is an FDA 510(k) clearance for TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K780787 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Jun 1978
Decision
25d
Days
Class 2
Risk

K780787 is an FDA 510(k) clearance for the TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on June 6, 1978 after a review of 25 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K780787

510(k) Number K780787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1978
Decision Date June 06, 1978
Days to Decision 25 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
63d faster than avg
Panel avg: 88d · This submission: 25d
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 K780787.
CHROMATOGRAPHY TUBES
K790581 · Miles Laboratories, Inc. · May 1979
ORTHO*T-3 RIA (PEG) KIT
K781481 · Ortho Diagnostics, Inc. · Sep 1978
RABBIT ANTIBODY TO HUMAN T3
K781284 · Pcl-Ria, Inc. · Aug 1978
TRIA-PEG RIA DIAG. KIT
K780292 · Nuclear Diagnostics, Inc. · Mar 1978
TRI-TAB-RIA
K772177 · Nuclear Medical Laboratories, Inc. · Dec 1977
IN VITRO T3 RIA TEST
K772108 · Clinical Assays, Inc. · Nov 1977