Cleared Traditional

K884267 - ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE ...

K884267 is the FDA 510(k) clearance for ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE ... by Alko Diagnostic Corp.. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K884267 · Alko Diagnostic Corp. · Chemistry device
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May 1989
Decision
205d
Days
Class 2
Risk

K884267 is an FDA 510(k) clearance for the ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on May 4, 1989 after a review of 205 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - 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 Alko Diagnostic Corp. devices

Submission Details

510(k) Number K884267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1988
Decision Date May 04, 1989
Days to Decision 205 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 88d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
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 - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 119
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K884267.
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IL1400, BGELECTROLYTE ANALYZER
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NOVA STAT PROFILE 7 ANALYZER QUALITY CONTROL MATER
K884143 · Nova Biomedical Corp. · Dec 1988
ANALYZER: NOVA STAT PROFILE 3 ANALYZER
K871397 · Nova Biomedical Corp. · Jun 1987
CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM
K865036 · Ciba Corning Diagnostics Corp. · Mar 1987