Cleared Traditional

K864838 - SIMULTRAC FREE T4[57CO]/TSH MAB[125I]

K864838 is the FDA 510(k) clearance for SIMULTRAC FREE T4[57CO]/TSH MAB[125I] 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 71-day FDA review.

K864838 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
71d
Days
Class 2
Risk

K864838 is an FDA 510(k) clearance for the SIMULTRAC FREE T4[57CO]/TSH MAB[125I]. 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 February 18, 1987 after a review of 71 days - a notably fast clearance cycle.

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: 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 K864838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1986
Decision Date February 18, 1987
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
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 K864838.
STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.
K870158 · American Dade · Mar 1987
IQ FTI IMMUNOASSAY
K865104 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987
IQ FREE T4 IMMUNOASSAY
K864658 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 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
AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT
K842482 · Amersham Corp. · Aug 1984