Cleared Traditional

K925913 - ACCESS FREE T4 ASSAY

K925913 is the FDA 510(k) clearance for ACCESS FREE T4 ASSAY by Bio-Rad Laboratories, Inc.. It is a Class 2 Toxicology device (product code CEC) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K925913 · Bio-Rad Laboratories, Inc. · Toxicology device
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Jan 1993
Decision
65d
Days
Class 2
Risk

K925913 is an FDA 510(k) clearance for the ACCESS(R) FREE T4 ASSAY. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on January 27, 1993 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1695 - the FDA toxicology device 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 Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K925913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1992
Decision Date January 27, 1993
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 87d · This submission: 65d
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 Toxicology devices follow this clearance model.

Regulatory Peers - CEC Radioimmunoassay, Free Thyroxine

All 61
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K925913.
IMMULITE FREE T4
K931704 · Diagnostic Products Corp. · Aug 1993
RADIAS FREE T4 ENZYME IMMUNOASSAY
K931110 · Bio-Rad · May 1993
BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM
K925842 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1993
VIDAS FREE THYROXINE(FT4) ASSAY
K925177 · Biomerieux Vitek, Inc. · Nov 1992
VISTA FREE THYROXINE ASSAY
K923572 · Syva Co. · Nov 1992
KODAK AMERLITE MAB FT3 ASSAY
K922713 · Eastman Kodak Company · Oct 1992