Cleared Traditional

K951169 - CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY

K951169 is an FDA 510(k) clearance for CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Chemistry device with product code LGS cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K951169 · Ciba Corning Diagnostics Corp. · Chemistry device
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Jun 1995
Decision
97d
Days
Class 2
Risk

K951169 is an FDA 510(k) clearance for the CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY. Classified as Fluorescence Polarization Immunoassay, Theophylline (product code LGS), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on June 20, 1995 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3880 - 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 - K951169

510(k) Number K951169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1995
Decision Date June 20, 1995
Days to Decision 97 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
9d slower than avg
Panel avg: 88d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGS Device Classification - Class 2, Special Controls

Product Code LGS Fluorescence Polarization Immunoassay, Theophylline
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3880
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 - LGS Fluorescence Polarization Immunoassay, Theophylline

All 9
Devices cleared under the same product code (LGS) and FDA review panel - the closest regulatory comparables to K951169.
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