Cleared Traditional

K895397 - CALCIUM AND PH ELECTROLYTE ANALYZER

K895397 is the FDA 510(k) clearance for CALCIUM AND PH ELECTROLYTE ANALYZER by Ionetics, Inc.. It is a Class 2 Chemistry device (product code JFP) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K895397 · Ionetics, Inc. · Chemistry device
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Dec 1989
Decision
102d
Days
Class 2
Risk

K895397 is an FDA 510(k) clearance for the CALCIUM AND PH ELECTROLYTE ANALYZER. Classified as Electrode, Ion Specific, Calcium (product code JFP), Class II - Special Controls.

Submitted by Ionetics, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on December 12, 1989 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Ionetics, Inc. devices

Submission Details

510(k) Number K895397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1989
Decision Date December 12, 1989
Days to Decision 102 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 88d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFP Electrode, Ion Specific, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - JFP Electrode, Ion Specific, Calcium

All 17
Devices cleared under the same product code (JFP) and FDA review panel - the closest regulatory comparables to K895397.
EASY LYTE CALCIUM ANALYZER
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ELECTRODE, ION SPECIFIC
K915675 · Alko Diagnostic Corp. · Apr 1992
IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY
K884771 · Instrumentation Laboratory CO · Feb 1989
CORNING CALCIUM PH ANALYZER 634
K844188 · Corning Medical & Scientific · Feb 1985
NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM
K830213 · Nova Biomedical Corp. · Apr 1983