Product Code: JFP FDA class 2 21 CFR 862.1145

Electrode, Ion Specific, Calcium

Clinical Chemistry

An Ion-Specific Electrode for Calcium is a clinical chemistry instrument that uses selective ion electrodes to measure ionized calcium concentration in blood or other specimens, providing data critical for diagnosing calcium metabolism disorders and guiding clinical management. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is JFP, regulated under 21 CFR 862.1145, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: JFP
Device Class: FDA class 2
Regulation Number: 862.1145
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 29 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K230300	i-STAT CG8+ cartridge with the i-STAT 1 System	Oct 27, 2023	Substantially Equivalent	Abbott Point of Care, Inc.
K191360	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Feb 14, 2020	Substantially Equivalent	Abbott Point of Care, Inc.
K191626	Stat Profile Prime ES Comp Plus Analyzer System	Aug 16, 2019	Substantially Equivalent	Nova Biomedical Corporation
K152327	EasyLyte Na/K/Cl/Ca Analyzer	Dec 01, 2016	Substantially Equivalent	Medica Corporation
K984299	AVL OPTI CRITICAL CARE ANALYZER	Dec 11, 1998	Substantially Equivalent	Avl Scientific Corp.
K972673	AVL 9181 ELECTROLYTE ANALYZER	Aug 20, 1997	Substantially Equivalent	Avl Scientific Corp.
K963694	EASYLYTE CALCIUM/CHLORIDE ANALYZER	Nov 27, 1996	Substantially Equivalent	Medica Corp.
K961458	AVL 9180 ELECTROLYTE ANALYZER	Jun 12, 1996	Substantially Equivalent	Avl Scientific Corp.
K960120	STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS	Mar 11, 1996	Substantially Equivalent	Nova Biomedical Corp.
K943091	EASY LYTE CALCIUM ANALYZER	Jan 17, 1995	Substantially Equivalent	Medica Corp.
K943702	AVL 988-4 ELECTROLYTE ANALYZER	Sep 09, 1994	Substantially Equivalent	Avl Scientific Corp.
K934642	I-STAT IONIZED CALCIUM TEST	Dec 17, 1993	Substantially Equivalent	I-Stat Corp.
K915675	ELECTRODE, ION SPECIFIC	Apr 29, 1992	Substantially Equivalent	Alko Diagnostic Corp.
K904726	LYTENING TM 6/R	Dec 18, 1990	Substantially Equivalent	Amdev, Inc.
K896316	EOS IONIZED CALCIUM TEST CARD	Feb 13, 1990	Substantially Equivalent	Eos Technology Corp.
K895397	CALCIUM AND PH ELECTROLYTE ANALYZER	Dec 12, 1989	Substantially Equivalent	Ionetics, Inc.
K884771	IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY	Feb 10, 1989	Substantially Equivalent	Instrumentation Laboratory CO
K884731	LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ	Feb 03, 1989	Substantially Equivalent	Amdev, Inc.
K880973	MICROLYTE 7	Sep 07, 1988	Substantially Equivalent	The Rupp & Bowman Co.
K873345	'MICROLYTE 4/5'	Sep 11, 1987	Substantially Equivalent	Kone Instruments, Inc.
K860639	IONIZED CALCIUM AND BLOOD PH TESTCARDS	Apr 21, 1986	Substantially Equivalent	Ilex Corp.
K844188	CORNING CALCIUM PH ANALYZER 634	Feb 04, 1985	Substantially Equivalent	Corning Medical & Scientific
K830213	NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM	Apr 05, 1983	Substantially Equivalent	Nova Biomedical Corp.
K830502	NOVA 8 IONIZED CALCIUM/PH ANALYZER	Mar 24, 1983	Substantially Equivalent	Nova Biomedical Corp.
K823389	SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ	Feb 02, 1983	Substantially Equivalent	Nova Biomedical Corp.
K810203	MODEL AM 722	Feb 10, 1981	Substantially Equivalent	Applied Medical Technologies
K802856	MINIATURE ION SELECTIVE ELECTRODES	Jan 28, 1981	Substantially Equivalent	Ionetics, Inc.
K801848	ICA1 IONIZED CALCIUM ANALYZER	Oct 31, 1980	Substantially Equivalent	The London Co.
K771643	NOVA 2 IONIZED CALCIUM ANALYZER	Sep 28, 1977	Substantially Equivalent	Nova Biomedical Corp.