Cleared Traditional

K864560 - IQ T4 IMMUNOASSAY

K864560 is the FDA 510(k) clearance for IQ T4 IMMUNOASSAY by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K864560 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Dec 1986
Decision
27d
Days
Class 2
Risk

K864560 is an FDA 510(k) clearance for the IQ T4 IMMUNOASSAY. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 16, 1986 after a review of 27 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 K864560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1986
Decision Date December 16, 1986
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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 74
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K864560.
DELFIA(TM) THYROXINE (T4) KIT
K871303 · Lkb Instruments, Inc. · Jun 1987
MICROMEDIC NEONATAL T4 KIT
K871008 · Micromedic Systems · May 1987
CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY
K870965 · Ciba Corning Diagnostics Corp. · May 1987
MMS T4 RIA KIT
K861320 · Micromedic Systems · Apr 1986
STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY
K860421 · American Dade · Feb 1986
T4 RIA
K833850 · Syncor Intl. Corp. · Jan 1984