Cleared Traditional

K943091 - EASY LYTE CALCIUM ANALYZER

K943091 is an FDA 510(k) clearance for EASY LYTE CALCIUM ANALYZER, manufactured by Medica Corp.. The device is a Class 2 Chemistry device with product code JFP cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K943091 · Medica Corp. · Chemistry device
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Jan 1995
Decision
203d
Days
Class 2
Risk

K943091 is an FDA 510(k) clearance for the EASY LYTE CALCIUM ANALYZER. Classified as Electrode, Ion Specific, Calcium (product code JFP), Class II - Special Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on January 17, 1995 after a review of 203 days - an extended review 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: 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 Medica Corp. devices

FDA 510(k) Submission Details - K943091

510(k) Number K943091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1994
Decision Date January 17, 1995
Days to Decision 203 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 88d · This submission: 203d
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 17
Devices cleared under the same product code (JFP) and FDA review panel - the closest regulatory comparables to K943091.
EASYLYTE CALCIUM/CHLORIDE ANALYZER
K963694 · Medica Corp. · Nov 1996
AVL 9180 ELECTROLYTE ANALYZER
K961458 · Avl Scientific Corp. · Jun 1996
STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS
K960120 · Nova Biomedical Corp. · Mar 1996
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