Cleared Traditional

ACCESS(R) THYROXINE ASSAY (K926475) - FDA 510(k) Clearance

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

K926475 · Bio-Rad Laboratories, Inc. · Chemistry device
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Jun 1993
Decision
168d
Days
Class 2
Risk

K926475 is an FDA 510(k) clearance for the ACCESS(R) THYROXINE ASSAY. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on June 15, 1993 after a review of 168 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K926475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1992
Decision Date June 15, 1993
Days to Decision 168 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 88d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 85
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K926475.
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EMIT THYROXINE ASSAY
K880620 · Syva Co. · Mar 1988