Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1145](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1145) → JFP — Electrode, Ion Specific, Calcium # JFP · Electrode, Ion Specific, Calcium _Clinical Chemistry · 21 CFR 862.1145 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP ## Overview - **Product Code:** JFP - **Device Name:** Electrode, Ion Specific, Calcium - **Regulation:** [21 CFR 862.1145](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1145) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) - **3rd-party reviewable:** yes ## Identification A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 29) Showing 20 most recent of 29 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K230300](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K230300.md) | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Oct 27, 2023 | SESE | | [K191360](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K191360.md) | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Feb 14, 2020 | SESE | | [K191626](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K191626.md) | Stat Profile Prime ES Comp Plus Analyzer System | Nova Biomedical Corporation | Aug 16, 2019 | SESE | | [K152327](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K152327.md) | EasyLyte Na/K/Cl/Ca Analyzer | Medica Corporation | Dec 1, 2016 | SESE | | [K984299](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K984299.md) | AVL OPTI CRITICAL CARE ANALYZER | Avl Scientific Corp. | Dec 11, 1998 | SESE | | [K972673](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K972673.md) | AVL 9181 ELECTROLYTE ANALYZER | Avl Scientific Corp. | Aug 20, 1997 | SESE | | [K963694](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K963694.md) | EASYLYTE CALCIUM/CHLORIDE ANALYZER | Medica Corp. | Nov 27, 1996 | SESE | | [K961458](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K961458.md) | AVL 9180 ELECTROLYTE ANALYZER | Avl Scientific Corp. | Jun 12, 1996 | SESE | | [K960120](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K960120.md) | STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS | Nova Biomedical Corp. | Mar 11, 1996 | SESE | | [K943091](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K943091.md) | EASY LYTE CALCIUM ANALYZER | Medica Corp. | Jan 17, 1995 | SESE | | [K943702](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K943702.md) | AVL 988-4 ELECTROLYTE ANALYZER | Avl Scientific Corp. | Sep 9, 1994 | SESE | | [K934642](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K934642.md) | I-STAT IONIZED CALCIUM TEST | I-Stat Corp. | Dec 17, 1993 | SESE | | [K915675](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K915675.md) | ELECTRODE, ION SPECIFIC | Alko Diagnostic Corp. | Apr 29, 1992 | SESE | | [K904726](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K904726.md) | LYTENING TM 6/R | Amdev, Inc. | Dec 18, 1990 | SESE | | [K896316](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K896316.md) | EOS IONIZED CALCIUM TEST CARD | Eos Technology Corp. | Feb 13, 1990 | SESE | | [K895397](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K895397.md) | CALCIUM AND PH ELECTROLYTE ANALYZER | Ionetics, Inc. | Dec 12, 1989 | SESE | | [K884771](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K884771.md) | IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY | Instrumentation Laboratory CO | Feb 10, 1989 | SESE | | [K884731](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K884731.md) | LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ | Amdev, Inc. | Feb 3, 1989 | SESE | | [K880973](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K880973.md) | MICROLYTE 7 | The Rupp & Bowman Co. | Sep 7, 1988 | SESE | | [K873345](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP/K873345.md) | 'MICROLYTE 4/5' | Kone Instruments, Inc. | Sep 11, 1987 | SESE | ## Top Applicants - Nova Biomedical Corp. — 5 clearances - Avl Scientific Corp. — 4 clearances - Abbott Point of Care, Inc. — 2 clearances - Amdev, Inc. — 2 clearances - Ionetics, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com