Cleared Traditional

BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM (K925842) - FDA 510(k) Clearance

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

K925842 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
153d
Days
Class 2
Risk

K925842 is an FDA 510(k) clearance for the BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sparks, US). The FDA issued a Cleared decision on April 20, 1993 after a review of 153 days - an extended review 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: 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 K925842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1992
Decision Date April 20, 1993
Days to Decision 153 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 88d · This submission: 153d
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 40
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K925842.
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)
K930322 · Heraeus Kulzer, Inc. · Nov 1993
IMMULITE FREE T4
K931704 · Diagnostic Products Corp. · Aug 1993
RADIAS FREE T4 ENZYME IMMUNOASSAY
K931110 · Bio-Rad · May 1993
VISTA FREE THYROXINE ASSAY
K923572 · Syva Co. · Nov 1992
KODAK AMERLITE MAB FT3 ASSAY
K922713 · Eastman Kodak Company · Oct 1992
AMERLITE MAB FT4 ASSAY
K920247 · Eastman Kodak Company · Mar 1992