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) → CIC — Cresolphthalein Complexone, Calcium # CIC · Cresolphthalein Complexone, 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/CIC ## Overview - **Product Code:** CIC - **Device Name:** Cresolphthalein Complexone, 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 99) Showing 20 most recent of 99 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K130870](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K130870.md) | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) | Hitachi Chemical Diagnostics, Inc. | May 2, 2013 | SESE | | [K083339](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K083339.md) | DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) | Siemens Healthcare Diagnostics, Inc. | Mar 9, 2009 | SESE | | [K070249](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K070249.md) | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H | Horiba Abx | Apr 26, 2007 | SESE | | [K053401](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K053401.md) | SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS | Arkray, Inc. | Mar 24, 2006 | SESE | | [K050077](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K050077.md) | SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS | Arkray, Inc. | Feb 15, 2005 | SESE | | [K041009](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K041009.md) | RAICHEM CALCIUM (OCPC) LIQUID REAGENT | Hemagen Diagnostics, Inc. | Jun 25, 2004 | SESE | | [K023105](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K023105.md) | ATAC CALCIUM REAGENT AND ATAC CALIBRATOR | Elan Diagnostics | Mar 13, 2003 | SESE | | [K013652](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K013652.md) | WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 | Wiener Laboratories Saic | Dec 21, 2001 | SESE | | [K000375](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K000375.md) | RANDOX CALCIUM | Randox Laboratories, Ltd. | Apr 5, 2000 | SESE | | [K991111](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K991111.md) | BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 | A.P. Total Care, Inc. | May 25, 1999 | SESE | | [K971907](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K971907.md) | CALCIUM REAGENT | Carolina Liquid Chemistries Corp. | Jun 24, 1997 | SESE | | [K963292](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K963292.md) | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | Roche Diagnostic Systems, Inc. | Oct 31, 1996 | SESE | | [K955939](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K955939.md) | CALCIUM REAGENT | Derma Media Lab., Inc. | Mar 13, 1996 | SESE | | [K944258](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K944258.md) | CALCIUM REAGENT | Olympus America, Inc. | Jan 5, 1995 | SESE | | [K931362](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K931362.md) | IL TEST CALCIUM | Instrumentation Laboratory CO | Feb 1, 1994 | SESE | | [K932158](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K932158.md) | CALCIUM TEST ITEM NUMBER 65409 | Em Diagnostic Systems, Inc. | Sep 27, 1993 | SESE | | [K924435](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K924435.md) | OLYMPUS CALCIUM REAGENT | Olympus Corp. | Oct 19, 1992 | SESE | | [K923034](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K923034.md) | MILES URINE CALCIUM METHOD | Heraeus Kulzer, Inc. | Sep 15, 1992 | SESE | | [K922233](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K922233.md) | OLYMPUS CALCIUM REAGENT | Olympus Corp. | Jul 10, 1992 | SESE | | [K921625](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K921625.md) | CALCIUM-ARSENAZO III REAGENT SET | Pointe Scientific, Inc., | May 13, 1992 | SESE | ## Top Applicants - Em Diagnostic Systems, Inc. — 7 clearances - Abbott Laboratories — 3 clearances - American Research Products Co. — 3 clearances - Boehringer Mannheim Corp. — 3 clearances - Diagnostic Chemicals, Ltd. (Usa) — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC) **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