Cleared Traditional

ACCESS FREE T3 ASSAY (K960913) - FDA 510(k) Clearance

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

K960913 · Bio-Rad Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
23d
Days
Class 2
Risk

K960913 is an FDA 510(k) clearance for the ACCESS FREE T3 ASSAY. 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 March 29, 1996 after a review of 23 days - a notably fast clearance 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: 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 K960913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1996
Decision Date March 29, 1996
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
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 K960913.
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