Product Code: CIC FDA class 2 21 CFR 862.1145

Cresolphthalein Complexone, Calcium

Clinical Chemistry

The Cresolphthalein Complexone, Calcium test system (product code CIC) is an in-vitro diagnostic device used in clinical chemistry to measure calcium concentrations in serum or plasma using a cresolphthalein complexone (CPC) colorimetric method, a widely used photometric technique for routine calcium testing. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1145 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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FEI Numbers

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Unique Applicants

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Basic Information

Product Code: CIC
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 99 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K130870	HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)	May 02, 2013	Substantially Equivalent	Hitachi Chemical Diagnostics, Inc.
K083339	DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)	Mar 09, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K070249	ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H	Apr 26, 2007	Substantially Equivalent	Horiba Abx
K053401	SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS	Mar 24, 2006	Substantially Equivalent	Arkray, Inc.
K050077	SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS	Feb 15, 2005	Substantially Equivalent	Arkray, Inc.
K041009	RAICHEM CALCIUM (OCPC) LIQUID REAGENT	Jun 25, 2004	Substantially Equivalent	Hemagen Diagnostics, Inc.
K023105	ATAC CALCIUM REAGENT AND ATAC CALIBRATOR	Mar 13, 2003	Substantially Equivalent	Elan Diagnostics
K013652	WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002	Dec 21, 2001	Substantially Equivalent	Wiener Laboratories Saic
K000375	RANDOX CALCIUM	Apr 05, 2000	Substantially Equivalent	Randox Laboratories, Ltd.
K991111	BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02	May 25, 1999	Substantially Equivalent	A.P. Total Care, Inc.
K971907	CALCIUM REAGENT	Jun 24, 1997	Substantially Equivalent	Carolina Liquid Chemistries Corp.
K963292	COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS	Oct 31, 1996	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K955939	CALCIUM REAGENT	Mar 13, 1996	Substantially Equivalent	Derma Media Lab., Inc.
K944258	CALCIUM REAGENT	Jan 05, 1995	Substantially Equivalent	Olympus America, Inc.
K931362	IL TEST CALCIUM	Feb 01, 1994	Substantially Equivalent	Instrumentation Laboratory CO
K932158	CALCIUM TEST ITEM NUMBER 65409	Sep 27, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K924435	OLYMPUS CALCIUM REAGENT	Oct 19, 1992	Substantially Equivalent	Olympus Corp.
K923034	MILES URINE CALCIUM METHOD	Sep 15, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K922233	OLYMPUS CALCIUM REAGENT	Jul 10, 1992	Substantially Equivalent	Olympus Corp.
K921625	CALCIUM-ARSENAZO III REAGENT SET	May 13, 1992	Substantially Equivalent	Pointe Scientific, Inc.,
K912027	CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL	Jan 30, 1992	Substantially Equivalent	Enzyme Technology, Inc.
K905659	SYSTEMATE CALCIUM (EPOS APPLICATION) #65409	Jan 15, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K903233	SYNERMED CALCIUM REAGENT KIT	Oct 04, 1990	Substantially Equivalent	Synermed, Inc.
K903896	CALCIUM ARSENAZO III REAGENT	Sep 13, 1990	Substantially Equivalent	Trace Scientific , Ltd.
K896224	COBAS READY CALCIUM REAGENT	Aug 17, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K902479	CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432	Jul 17, 1990	Substantially Equivalent	Amresco, Inc.
K901226	CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)	Apr 19, 1990	Substantially Equivalent	Technicon Instruments Corp.
K894407	ABBOTT SPECTRUM(R) CALCIUM REAGENT	Sep 25, 1989	Substantially Equivalent	Abbott Laboratories
K893778	CALCIUM TEST ITEM NUMBER: 65409	Sep 05, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K891217	IQ CALCIUM	May 03, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K884599	TECHNICON RA-100 SYSTEM CALCIUM METHOD	Jan 27, 1989	Substantially Equivalent	Technicon Instruments Corp.
K884986	CALCIUM TEST ITEM NUMBER: SR1009	Jan 13, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K884480	BIOTROL BILIRUBIN MONOREACTIF	Nov 29, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K884433	TECHNICON ASSIST(R) CALCIUM METHOD	Nov 29, 1988	Substantially Equivalent	Technicon Instruments Corp.
K882586	A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM	Aug 08, 1988	Substantially Equivalent	A-Kem, Inc.
K880308	CALCIUM	May 27, 1988	Substantially Equivalent	Catachem, Inc.
K881054	CALCIUM, CATALOGUE NUMBER 122-20	Apr 18, 1988	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K880845	CALCIUM REAGENT SET	Apr 05, 1988	Substantially Equivalent	Tech-Neal Scientific, Inc.
K874496	CALCIUM ASSAY KIT, NUMBER 120-19	Feb 11, 1988	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K873519	PARAMAX CALCIUM REAGENT	Dec 14, 1987	Substantially Equivalent	Baxter Healthcare Corp
K874131	CRESOLPHTHALEIN COMPLEXONE, CALCIUM	Dec 04, 1987	Substantially Equivalent	Pointe Scientific, Inc.,
K873697	MULTICHEM CALCIUM S0910	Oct 02, 1987	Substantially Equivalent	Simmler, Inc.
K873334	WAKO(TM) AUTOKIT CALCIUM	Oct 02, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K870362	CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD	Aug 21, 1987	Substantially Equivalent	Trace Scientific , Ltd.
K872306	SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA)	Aug 18, 1987	Substantially Equivalent	Boehringer Mannheim Corp.
K871152	SIGMA'S CALCIUM PROCEDURE NO. 587	Jun 12, 1987	Substantially Equivalent	Sigma Diagnostics, Inc.
K871811	SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)	May 26, 1987	Substantially Equivalent	Boehringer Mannheim Corp.
K870629	CALCIUM TEST	Apr 29, 1987	Substantially Equivalent	Sclavo, Inc.
K870170	EASY-TEST CALCIUM (CA), ITEM NO. 67528/93	Mar 06, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K864661	UNIFAST CALCIUM TEST	Feb 04, 1987	Substantially Equivalent	Sclavo, Inc.
K864741	CRESOLPHTHALEIN COMPLEXONE, CALCIUM	Jan 09, 1987	Substantially Equivalent	Tech-Co, Inc.
K863670	VISION (TM) CALCIUM	Nov 13, 1986	Substantially Equivalent	Abbott Laboratories
K863256	CALCIUM PROCEDURE	Sep 26, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K863003	EMDS(TM) CALCIUM TESTPACKS, #67687/95	Sep 16, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K862274	ANALYST ANALYTICAL TEST ROTORS	Jul 29, 1986	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K860664	CRESOLPHTHALEIN COMPLEXONE, CALCIUM	Jun 27, 1986	Substantially Equivalent	Amresco, Inc.
K861657	CALCIUM PROCEDURE	May 29, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K860425	A-GENT LIQUID CALCIUM	Apr 03, 1986	Substantially Equivalent	Abbott Laboratories
K860044	CALCIUM (CPC) REAGENT SET	Feb 11, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K855041	CALCIUM LIQUID STABLE REAGENT SET	Jan 22, 1986	Substantially Equivalent	Medical Analysis Systems, Inc.
K854716	NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909	Jan 07, 1986	Substantially Equivalent	Nobel Scientific Industries, Inc.
K853050	CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ	Aug 02, 1985	Substantially Equivalent	Simmler, Inc.
K852657	AMRESCO CALCIUM REAGENT SET	Jul 15, 1985	Substantially Equivalent	American Research Products Co.
K852002	CA BUFFER CA DYE	Jun 25, 1985	Substantially Equivalent	Alpkem Corp.
K850929	CALCIUM	Jun 10, 1985	Substantially Equivalent	Dilab, Inc.
K850281	CALCIUM	Feb 06, 1985	Substantially Equivalent	Boehringer Mannheim Corp.
K844243	TOTAL BILIRUBIN FOR DEMAND ANALYZER	Jan 03, 1985	Substantially Equivalent	Advanced Biomedical Methods, Inc.
K844241	CALCIUM REAGENT FOR DEMAND ANALYZER	Jan 03, 1985	Substantially Equivalent	Advanced Biomedical Methods, Inc.
K843895	TOTAL CALCIUM REAGENT SET	Oct 30, 1984	Substantially Equivalent	Livonia Diagnostics, Inc.
K843353	RAICHEM CALCIUM REAGENT	Sep 20, 1984	Substantially Equivalent	Reagents Applications, Inc.
K843152	SYSTEMATE CALCIUM 67214	Aug 29, 1984	Substantially Equivalent	Em Diagnostic Systems, Inc.
K842509	CALCIUM ASSAY KIT	Jul 20, 1984	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K841051	SERUM CALCIUM REAGENT SET	May 01, 1984	Substantially Equivalent	Medical Specialties, Inc.
K834336	FLOW-PAC CALCIUM REAGENT SET	Feb 21, 1984	Substantially Equivalent	American Research Products Co.
K833035	CALCIUM DYE REAGENT-CS-718-A/BUFFER	Nov 03, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K832708	PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS	Oct 14, 1983	Substantially Equivalent	American Dade
K832183	SANDARE CALCIUM PROCEDURE	Aug 24, 1983	Substantially Equivalent	Sandare Chemical Co., Inc.
K830238	ULTRA CHEM CRESOLCAVERSACHEM #65082	Feb 18, 1983	Substantially Equivalent	Emd Chemicals, Inc.
K823756	ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082	Jan 12, 1983	Substantially Equivalent	Em Industries, Inc.
K823577	COBAS REAGENT FOR CALCIUM	Jan 07, 1983	Substantially Equivalent	Hoffmann-La Roche, Inc.
K823219	LIQUIZYME CALCIUM REAGENT SET	Dec 03, 1982	Substantially Equivalent	American Research Products Co.
K822469	PSI CALCIUM REAGENT	Sep 14, 1982	Substantially Equivalent	Pointe Scientific, Inc.,
K821196	SERUM CALCIUM REAGENT SET	Jul 13, 1982	Substantially Equivalent	Omega Medical Electronics
K820241	WAKO CALCIUM C TEST	Feb 12, 1982	Substantially Equivalent	Wako Chemicals USA, Inc.
K820090	ASTRA-T CALCIUM REAGENT	Jan 28, 1982	Substantially Equivalent	Hi Chem, Inc.
K812835	TOTAL CALCIUM REAGENT SET	Oct 09, 1981	Unknown	Anco Medical Reagents & Assoc.
K812110	GILCHEM CALCIUM REAGENT	Aug 13, 1981	Substantially Equivalent	Gilford Diagnostics
K811748	KING DIAGNOSTICS CALCIUM TEST	Jul 10, 1981	Substantially Equivalent	King Diagnostics, Inc.
K802923	BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY	Dec 19, 1980	Substantially Equivalent	Beckman Instruments, Inc.
K802164	8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM.	Oct 10, 1980	Substantially Equivalent	Panmed, Inc.
K800680	REAGENTS FOR DETERM. CALCIUM IN HUMAN	May 28, 1980	Substantially Equivalent	Diagnostic Solutions, Inc.
K792337	DONNECT. DIAG. CALCIUM DIAG. REAGENT	Dec 06, 1979	Substantially Equivalent	Connecticut Diagnostics, Ltd.
K780983	CALCIUM REAGENT SYSTEM NO. 585	Jul 27, 1978	Substantially Equivalent	Sigma Chemical Co.
K771831	CALCIUM	Oct 25, 1977	Substantially Equivalent	Gamma Enterprises, Inc.
K771310	CALCIUM REAGENT	Aug 03, 1977	Substantially Equivalent	Mallinckrodt Critical Care
K770460	CENTRIFI CHEM CALCIUM REAGENT	Jun 02, 1977	Substantially Equivalent	Union Carbide Corp.
K770449	CALCIUM PROCEDURE, TEKPOINT DIRECT	May 03, 1977	Substantially Equivalent	Icn Pharmaceuticals, Inc.
K760468	TEST, REFORMULATED HYCEL HMA CALCIUM	Nov 01, 1976	Substantially Equivalent	Hycel, Inc.
K760475	REAGENT, CALCIUM DETERMINATION	Oct 29, 1976	Substantially Equivalent	Simmler & Son, Inc.