Cleared Traditional

K973966 - ACCESS TOTAL T3 REAGENTS ON THE ACCESS ...

K973966 is an FDA 510(k) clearance for ACCESS TOTAL T3 REAGENTS ON THE ACCESS ..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K973966 · Beckman Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
14d
Days
Class 2
Risk

K973966 is an FDA 510(k) clearance for the ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Chaska, US). The FDA issued a Cleared decision on October 31, 1997 after a review of 14 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K973966

510(k) Number K973966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1997
Decision Date October 31, 1997
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDP Device Classification - Class 2, Special Controls

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 100
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K973966.
ABBOTT ARCHITECT TOTAL T3
K983434 · Abbott Laboratories · Nov 1998
ABBOTT ARCHITECT FREE T3
K983439 · Abbott Laboratories · Nov 1998
IMMULITE FREE T3
K974634 · Diagnostic Products Corp. · Jan 1998
DSL ACTIVE T3 EIA
K971270 · Diagnostic Systems Laboratories, Inc. · May 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT
K965058 · Nichols Institute Diagnostics · Mar 1997
VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020)
K970016 · Johnson & Johnson Clinical Diagnostics, Inc. · Jan 1997