Cleared Traditional

MONOCLONAL ANTIBODY T4 RADIO-KIT (K823265) - FDA 510(k) Clearance

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

K823265 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device

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Dec 1982

Decision

37d

Days

Class 2

Risk

K823265 is an FDA 510(k) clearance for the MONOCLONAL ANTIBODY T4 RADIO-KIT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 9, 1982 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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	K823265 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 02, 1982
Decision Date	December 09, 1982
Days to Decision	37 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

51d faster than avg

Panel avg: 88d · This submission: 37d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	CDX Radioimmunoassay, Total Thyroxine
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1700

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 - CDX Radioimmunoassay, Total Thyroxine

All 36

Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K823265.

IQ T4 IMMUNOASSAY

K864560 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1986

STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY

K860421 · American Dade · Feb 1986

COAT-A-COUNT NEONATAL T4 KIT RIA KIT

K831107 · Diagnostic Products Corp. · May 1983

QUANTAPHASE T-4 RIA

K811787 · Bio-Rad · Jul 1981

COAT-A-COUNT T4 RIA KIT

K811315 · Diagnostic Products Corp. · May 1981

IMMU-TRACE T4 RIA PROCEDURE

K803046 · American Dade · Jan 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 K823265

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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