Cleared Traditional

K864658 - IQ FREE T4 IMMUNOASSAY

K864658 is the FDA 510(k) clearance for IQ FREE T4 IMMUNOASSAY by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Chemistry device (product code CEC) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K864658 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
104d
Days
Class 2
Risk

K864658 is an FDA 510(k) clearance for the IQ FREE T4 IMMUNOASSAY. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 12, 1987 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K864658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1986
Decision Date March 12, 1987
Days to Decision 104 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
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 - CEC Radioimmunoassay, Free Thyroxine

All 66
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K864658.
DIAGNOSTIC KIT FREE T3 AND FREE T4
K870268 · Sclavo, Inc. · Sep 1987
STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.
K870158 · American Dade · Mar 1987
IQ FTI IMMUNOASSAY
K865104 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987
SIMULTRAC FREE T4[57CO]/TSH MAB[125I]
K864838 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA
K860251 · Amersham Corp. · Feb 1986
SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY
K853628 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1985