Cleared Traditional

K931110 - RADIAS FREE T4 ENZYME IMMUNOASSAY

K931110 is the FDA 510(k) clearance for RADIAS FREE T4 ENZYME IMMUNOASSAY by Bio-Rad. It is a Class 2 Chemistry device (product code CEC) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K931110 · Bio-Rad · Chemistry device
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May 1993
Decision
78d
Days
Class 2
Risk

K931110 is an FDA 510(k) clearance for the RADIAS FREE T4 ENZYME IMMUNOASSAY. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on May 20, 1993 after a review of 78 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 Bio-Rad devices

Submission Details

510(k) Number K931110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1993
Decision Date May 20, 1993
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
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 63
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K931110.
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)
K930322 · Heraeus Kulzer, Inc. · Nov 1993
STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC
K932912 · Baxter Diagnostics, Inc. · Oct 1993
IMMULITE FREE T4
K931704 · Diagnostic Products Corp. · Aug 1993
BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM
K925842 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1993
ACCESS(R) FREE T4 ASSAY
K925913 · Bio-Rad Laboratories, Inc. · Jan 1993
VIDAS FREE THYROXINE(FT4) ASSAY
K925177 · Biomerieux Vitek, Inc. · Nov 1992