Cleared Traditional

K932747 - CIBA CORNING ACS FREE T3 IMMUNOASSAY

K932747 is an FDA 510(k) clearance for CIBA CORNING ACS FREE T3 IMMUNOASSAY, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K932747 · Ciba Corning Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
178d
Days
Class 2
Risk

K932747 is an FDA 510(k) clearance for the CIBA CORNING ACS FREE T3 IMMUNOASSAY. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on December 3, 1993 after a review of 178 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K932747

510(k) Number K932747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1993
Decision Date December 03, 1993
Days to Decision 178 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 88d · This submission: 178d
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 104
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K932747.
AXSYM TOTAL T3
K934517 · Abbott Laboratories · Jun 1994
VIDAS T3 ASSAY
K934764 · Biomerieux Vitek, Inc. · Mar 1994
COBAS(R) CORE T3 EIA
K932608 · Roche Diagnostic Systems, Inc. · Dec 1993
MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT
K925436 · Medix Biotech, Inc. · Dec 1992
VISTA TRIIODOTHYRONINE ASSAY
K923571 · Syva Co. · Oct 1992
KODAK AMERLEX MAB FT3 ASSAY
K922771 · Eastman Kodak Company · Oct 1992