Cleared Traditional

K934642 - I-STAT IONIZED CALCIUM TEST

K934642 is the FDA 510(k) clearance for I-STAT IONIZED CALCIUM TEST by I-Stat Corp.. It is a Class 2 Chemistry device (product code JFP) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K934642 · I-Stat Corp. · Chemistry device
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Dec 1993
Decision
87d
Days
Class 2
Risk

K934642 is an FDA 510(k) clearance for the I-STAT IONIZED CALCIUM TEST. Classified as Electrode, Ion Specific, Calcium (product code JFP), Class II - Special Controls.

Submitted by I-Stat Corp. (Princeton, US). The FDA issued a Cleared decision on December 17, 1993 after a review of 87 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 I-Stat Corp. devices

Submission Details

510(k) Number K934642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1993
Decision Date December 17, 1993
Days to Decision 87 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 88d · This submission: 87d
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 12
Devices cleared under the same product code (JFP) and FDA review panel - the closest regulatory comparables to K934642.
EASYLYTE CALCIUM/CHLORIDE ANALYZER
K963694 · Medica Corp. · Nov 1996
STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS
K960120 · Nova Biomedical Corp. · Mar 1996
EASY LYTE CALCIUM ANALYZER
K943091 · Medica Corp. · Jan 1995
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