Cleared Traditional

ACCESS(R) TOTAL T3 (K940833) - FDA 510(k) Clearance

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

K940833 · Bio-Rad Laboratories, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Sep 1994
Decision
196d
Days
Class 2
Risk

K940833 is an FDA 510(k) clearance for the ACCESS(R) TOTAL T3. 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 September 7, 1994 after a review of 196 days - an extended review cycle.

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 K940833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1994
Decision Date September 07, 1994
Days to Decision 196 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
108d slower than avg
Panel avg: 88d · This submission: 196d
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 143
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K940833.
ABBOTT ARCHITECT TOTAL T3
K983434 · Abbott Laboratories · Nov 1998
ABBOTT ARCHITECT FREE T3
K983439 · Abbott Laboratories · Nov 1998
AXSYM FREE TRIIODOTHYRONINE (FREE T3)
K963827 · Abbott Laboratories · Oct 1996
IMX FREE TRIIODOTHYRONINE (FREE T3)
K963833 · Abbott Laboratories · Oct 1996
AXSYM TOTAL T3
K934517 · Abbott Laboratories · Jun 1994
VISTA TRIIODOTHYRONINE ASSAY
K923571 · Syva Co. · Oct 1992