Cleared Traditional

CIBA CORNING ACS FT3 IMMUNOASSAY (K940482) - FDA 510(k) Clearance

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

K940482 · Ciba Corning Diagnostics Corp. · Chemistry device
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Apr 1994
Decision
83d
Days
Class 2
Risk

K940482 is an FDA 510(k) clearance for the CIBA CORNING ACS FT3 IMMUNOASSAY. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on April 26, 1994 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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 Ciba Corning Diagnostics Corp. devices

Submission Details

510(k) Number K940482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1994
Decision Date April 26, 1994
Days to Decision 83 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
5d faster than avg
Panel avg: 88d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 - CEC Radioimmunoassay, Free Thyroxine

All 47
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K940482.
COBAS CORE FREE T3 EIA
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AXSYM FREE THYROXINE ( FREE T4 )
K934544 · Abbott Laboratories · Jun 1994
COBAS(R) CORE FT4 EIA
K932607 · Roche Diagnostic Systems, Inc. · Jan 1994
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K930322 · Heraeus Kulzer, Inc. · Nov 1993
IMMULITE FREE T4
K931704 · Diagnostic Products Corp. · Aug 1993