Cleared Traditional

K860639 - IONIZED CALCIUM AND BLOOD PH TESTCARDS

K860639 is the FDA 510(k) clearance for IONIZED CALCIUM AND BLOOD PH TESTCARDS by Ilex Corp.. It is a Class 2 Chemistry device (product code JFP) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K860639 · Ilex Corp. · Chemistry device
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Apr 1986
Decision
60d
Days
Class 2
Risk

K860639 is an FDA 510(k) clearance for the IONIZED CALCIUM AND BLOOD PH TESTCARDS. Classified as Electrode, Ion Specific, Calcium (product code JFP), Class II - Special Controls.

Submitted by Ilex Corp. (Attleboro, US). The FDA issued a Cleared decision on April 21, 1986 after a review of 60 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ilex Corp. devices

Submission Details

510(k) Number K860639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1986
Decision Date April 21, 1986
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 88d · This submission: 60d
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 16
Devices cleared under the same product code (JFP) and FDA review panel - the closest regulatory comparables to K860639.
EASY LYTE CALCIUM ANALYZER
K943091 · Medica Corp. · Jan 1995
AVL 988-4 ELECTROLYTE ANALYZER
K943702 · Avl Scientific Corp. · Sep 1994
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
NOVA 8 IONIZED CALCIUM/PH ANALYZER
K830502 · Nova Biomedical Corp. · Mar 1983