Cleared Traditional

FREE T3 SOLID PHASE RADIOIMMUNOASSAY (K840959) - FDA 510(k) Clearance

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

K840959 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device

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Apr 1984

Decision

43d

Days

Class 2

Risk

K840959 is an FDA 510(k) clearance for the FREE T3 SOLID PHASE RADIOIMMUNOASSAY. 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 April 18, 1984 after a review of 43 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

Submission Details

510(k) Number	K840959 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 06, 1984
Decision Date	April 18, 1984
Days to Decision	43 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

45d faster than avg

Panel avg: 88d · This submission: 43d

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 38

Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K840959.

STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME

K883479 · Baxter Healthcare Corp · Oct 1988

ABBOTT IMX T3

K880087 · Abbott Laboratories · Apr 1988

TDX TOTAL T3

K851676 · Abbott Laboratories · May 1985

SOPHEIA T3 EIA KIT

K840050 · Diagnostic Products Corp. · Mar 1984

COAT-A-COUNT FREE T3 RIA KIT

K832164 · Diagnostic Products Corp. · Oct 1983

COAT-A-COUNT T3 RIA KIT

K812246 · Diagnostic Products Corp. · Aug 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K840959

Bd Becton Dickinson Vacutainer Systems Preanalytic

Washington, DC · US

Regulatory profile

632 submissions 625 cleared

99% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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