Cleared Traditional

CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM (K880353) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 9
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K880353.
hemochroma PLUS System
K182298 · Immunostics Inc., · Nov 2018
DiaSpect Tm, DiaSpect Tm Cuvettes
K172173 · Ekf Diagnostic GmbH · Apr 2018
IL682, CO-OXIMETER
K945677 · Instrumentation Laboratory CO · Oct 1995
HEMESPEC II
K803015 · Helena Laboratories · Dec 1980
HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.
K803016 · Helena Laboratories · Dec 1980
SYSING AND HEMOGLOBIN REAGENT
K780829 · Harleco · Jun 1978