Cleared Traditional

K895397 - CALCIUM AND PH ELECTROLYTE ANALYZER

K895397 is an FDA 510(k) clearance for CALCIUM AND PH ELECTROLYTE ANALYZER, manufactured by Ionetics, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K895397

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.

JFP Device Classification - Class 2, Special Controls

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 19
Devices cleared under the same product code (JFP) and FDA review panel - the closest regulatory comparables to K895397.
EASY LYTE CALCIUM ANALYZER
K943091 · Medica Corp. · Jan 1995
AVL 988-4 ELECTROLYTE ANALYZER
K943702 · Avl Scientific Corp. · Sep 1994
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