Cleared Traditional

K955435 - ACCESS TOTAL T3 ASSAY (MODIFICATION)

K955435 is the FDA 510(k) clearance for ACCESS TOTAL T3 ASSAY (MODIFICATION) by Bio-Rad Laboratories, Inc.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K955435 · Bio-Rad Laboratories, Inc. · Chemistry device
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Jan 1996
Decision
114d
Days
Class 2
Risk

K955435 is an FDA 510(k) clearance for the ACCESS TOTAL T3 ASSAY (MODIFICATION). Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on January 24, 1996 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 K955435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date January 24, 1996
Days to Decision 114 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
26d slower than avg
Panel avg: 88d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 78
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K955435.
ACCESS FREE T3 ASSAY
K960913 · Bio-Rad Laboratories, Inc. · Mar 1996
ACTIVE T3 RIA
K960550 · Diagnostic Systems Laboratories, Inc. · Mar 1996
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS
K952557 · Sigma Diagnostics, Inc. · Jan 1996
OPUS T3
K953160 · Behring Diagnostics, Inc. · Aug 1995
IMX T3 ASSAY
K944808 · Organon Teknika Corp. · Dec 1994
ACCESS(R) TOTAL T3
K940833 · Bio-Rad Laboratories, Inc. · Sep 1994