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) → CJY — Azo Dye, Calcium # CJY · Azo Dye, 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/CJY ## Overview - **Product Code:** CJY - **Device Name:** Azo Dye, 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 47) Showing 20 most recent of 47 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K244042](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K244042.md) | Calcium2 | Abbott Ireland | Feb 10, 2025 | SESE | | [K191396](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K191396.md) | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | HORIBA ABX SAS | Jul 26, 2019 | SESE | | [K182042](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K182042.md) | Randox Calcium (Ca) | Randox Laboratories, Ltd. | Oct 23, 2018 | SESE | | [K151113](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K151113.md) | ELITech Clinical Systems CALCIUM ARSENAZO | Elitechgroup | Jul 22, 2015 | SESE | | [K123171](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K123171.md) | ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT | HORIBA ABX SAS | Jul 3, 2013 | SESE | | [K120626](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K120626.md) | EON CALCIUM REGENT | Vital Diagnostics (Manufacturing) Ptyltd | Aug 22, 2012 | SESE | | [K083386](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K083386.md) | ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) | Siemens Healthcare Diagnostics | Apr 2, 2009 | SESE | | [K072356](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K072356.md) | S-TEST CA | Alfa Wassermann Diagnostic Technologies, Inc. | Jun 24, 2008 | SESE | | [K073355](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K073355.md) | CALCIUM, SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | Feb 28, 2008 | SESE | | [K072443](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K072443.md) | VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY | Ortho-Clinical Diagnostics, Inc. | Sep 24, 2007 | SESE | | [K072440](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K072440.md) | VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) | Ortho-Clinical Diagnostics, Inc. | Sep 20, 2007 | SESE | | [K062855](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K062855.md) | CALCIUM | Abbott Laboratories | Nov 22, 2006 | SESE | | [K061575](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K061575.md) | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 | Olympus America, Inc. | Oct 5, 2006 | SESE | | [K051757](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K051757.md) | CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 | Diagnostic Chemicals , Ltd. | Nov 10, 2005 | SESE | | [K040972](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K040972.md) | CALCIUM, AZO DYE REAGENT | Genchem, Inc. | Dec 27, 2004 | SESE | | [K021334](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K021334.md) | WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5 | Wiener Laboratories Saic | Sep 10, 2002 | SESE | | [K022049](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K022049.md) | MODIFICATION TO RAICHEM CALCIUM REAGENT | Hemagen Diagnostics, Inc. | Jul 19, 2002 | SESE | | [K011441](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K011441.md) | JAS CALCIUM (ARSENAZO) REAGENT | Jas Diagnostics, Inc. | Jul 9, 2001 | SESE | | [K983789](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K983789.md) | CARESIDE CALCIUM, ORIGINAL | Careside, Inc. | Dec 17, 1998 | SESE | | [K981794](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY/K981794.md) | HICHEM CALCIUM REAGENT KIT | Hichem Diagnostics | Jul 29, 1998 | SESE | ## Top Applicants - Harleco — 4 clearances - Abbott Laboratories — 2 clearances - Data Medical Associates, Inc. — 2 clearances - HORIBA ABX SAS — 2 clearances - Hichem Diagnostics — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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