Cleared Traditional

K880353 - CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM

K880353 is an FDA 510(k) clearance for CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Chemistry device with product code GKR cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K880353 · Ciba Corning Diagnostics Corp. · Chemistry device
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Jun 1988
Decision
141d
Days
Class 2
Risk

K880353 is an FDA 510(k) clearance for the CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on June 15, 1988 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.5620 - 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 - K880353

510(k) Number K880353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1988
Decision Date June 15, 1988
Days to Decision 141 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 88d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKR Device Classification - Class 2, Special Controls

Product Code GKR System, Hemoglobin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5620
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 - GKR System, Hemoglobin, Automated

All 21
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K880353.
IL682, CO-OXIMETER
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AVL OMNI ANALYZER
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HEMOGLOBIN REAGENT
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HEMOGLOBIN REAGENT SET
K841057 · Medical Specialties, Inc. · Mar 1984
KING DIAGNOSTICS HEMOGLOBIN TEST
K812127 · King Diagnostics, Inc. · Aug 1981
HEMESPEC II
K803015 · Helena Laboratories · Dec 1980