Cleared Traditional

K945367 - CIBA CORNING ACS CORTISOL IMMUNOASSAY (FDA 510(k) Clearance)

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

K945367 · Ciba Corning Diagnostics Corp. · Chemistry device
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May 1995
Decision
221d
Days
Class 2
Risk

K945367 is an FDA 510(k) clearance for the CIBA CORNING ACS CORTISOL IMMUNOASSAY. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on May 5, 1995 after a review of 221 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1205 - 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

Submission Details

510(k) Number K945367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1994
Decision Date May 05, 1995
Days to Decision 221 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 88d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGR Radioimmunoassay, Cortisol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1205
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.

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All 83
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