Product Code: CJY FDA class 2 21 CFR 862.1145

Azo Dye, Calcium

Clinical Chemistry

The Azo Dye, Calcium test system (product code CJY) is an in-vitro diagnostic device used in clinical chemistry to measure calcium concentrations in serum or urine using an azo dye colorimetric method, in which an azo dye chelates calcium to form a colored complex that is quantified photometrically. 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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Basic Information

Product Code: CJY
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 47 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K244042	Calcium2	Feb 10, 2025	Substantially Equivalent	Abbott Ireland
K191396	Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe	Jul 26, 2019	Substantially Equivalent	HORIBA ABX SAS
K182042	Randox Calcium (Ca)	Oct 23, 2018	Substantially Equivalent	Randox Laboratories, Ltd.
K151113	ELITech Clinical Systems CALCIUM ARSENAZO	Jul 22, 2015	Substantially Equivalent	Elitechgroup
K123171	ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT	Jul 03, 2013	Substantially Equivalent	HORIBA ABX SAS
K120626	EON CALCIUM REGENT	Aug 22, 2012	Substantially Equivalent	Vital Diagnostics (Manufacturing) Ptyltd
K083386	ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)	Apr 02, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K072356	S-TEST CA	Jun 24, 2008	Substantially Equivalent	Alfa Wassermann Diagnostic Technologies, Inc.
K073355	CALCIUM, SCAL, NORTROL, ABTROL	Feb 28, 2008	Substantially Equivalent	Thermofisher Scientific OY
K072443	VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY	Sep 24, 2007	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K072440	VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)	Sep 20, 2007	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K062855	CALCIUM	Nov 22, 2006	Substantially Equivalent	Abbott Laboratories
K061575	OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117	Oct 05, 2006	Substantially Equivalent	Olympus America, Inc.
K051757	CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91	Nov 10, 2005	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K040972	CALCIUM, AZO DYE REAGENT	Dec 27, 2004	Substantially Equivalent	Genchem, Inc.
K021334	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	Sep 10, 2002	Substantially Equivalent	Wiener Laboratories Saic
K022049	MODIFICATION TO RAICHEM CALCIUM REAGENT	Jul 19, 2002	Substantially Equivalent	Hemagen Diagnostics, Inc.
K011441	JAS CALCIUM (ARSENAZO) REAGENT	Jul 09, 2001	Substantially Equivalent	Jas Diagnostics, Inc.
K983789	CARESIDE CALCIUM, ORIGINAL	Dec 17, 1998	Substantially Equivalent	Careside, Inc.
K981794	HICHEM CALCIUM REAGENT KIT	Jul 29, 1998	Substantially Equivalent	Hichem Diagnostics
K982035	OLYMPUS CALCIUM ARSENAZO III REAGENT	Jun 24, 1998	Substantially Equivalent	Olympus Diagnostica GmbH
K981578	CA	Jun 16, 1998	Substantially Equivalent	Abbott Laboratories
K981232	CA	May 18, 1998	Substantially Equivalent	Abbott Mfg., Inc.
K974607	RANDOX CALCIUM	Feb 02, 1998	Substantially Equivalent	Randox Laboratories, Ltd.
K963536	SIGMA DIAGNOSTICS CALICIUM REAGENT	Oct 10, 1996	Substantially Equivalent	Sigma Diagnostics, Inc.
K961226	EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE	May 07, 1996	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K953395	SYNERMED CALCIUM REAGENT KIT	Aug 31, 1995	Substantially Equivalent	Synermed, Inc.
K944255	DMA CALCIUM PLUS PROCEDURE	Dec 06, 1994	Substantially Equivalent	Data Medical Associates, Inc.
K941764	HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808	May 13, 1994	Substantially Equivalent	Hi Chem, Inc.
K933678	SIGMA CALCIUM REAGENT	Mar 11, 1994	Substantially Equivalent	Sigma Chemical Co.
K922835	CALCIUM (AZ III) REAGENT	Aug 04, 1992	Substantially Equivalent	King Diagnostics, Inc.
K902476	CALCIUM:ARSENAZO III	Jul 17, 1990	Substantially Equivalent	Amresco, Inc.
K900231	COULTER CALCIUM REAGENT	Apr 03, 1990	Substantially Equivalent	Coulter Corp.
K895873	CALCIUM, CATALOGUE NUMBER140-20	Dec 12, 1989	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K894476	CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION	Oct 12, 1989	Substantially Equivalent	Catachem, Inc.
K894204	CALCIUM (ARSENAZO III) REAGENT	Oct 04, 1989	Substantially Equivalent	Sigma Diagnostics, Inc.
K891061	BIOTROL CALCIUM MONOREACTIF	Aug 10, 1989	Substantially Equivalent	Biotrol, USA, Inc.
K890584	HI CHEM CALCIUM REAGENT #88808	Apr 10, 1989	Substantially Equivalent	Hichem Diagnostics
K890302	CALCIUM PLUS PROCEDURE	Feb 27, 1989	Substantially Equivalent	Data Medical Associates, Inc.
K883453	ROCHE REAGENT FOR CALCIUM	Oct 25, 1988	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K880576	RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)	Jun 10, 1988	Substantially Equivalent	Reagents Applications, Inc.
K880949	SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER	Apr 05, 1988	Substantially Equivalent	Advanced Biomedical Methods, Inc.
K880242	KONE CALCIUM TEST	Mar 15, 1988	Substantially Equivalent	The Rupp & Bowman Co.
K813040	ULTRACHEM CA, ITEM #64975	Nov 10, 1981	Substantially Equivalent	Harleco
K771928	CALCIUM SET, ITEM NO. 65004	Nov 14, 1977	Substantially Equivalent	Harleco
K770817	ULTRACHEM CALCIUM	Jul 11, 1977	Substantially Equivalent	Harleco
K761029	AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL	Nov 30, 1976	Substantially Equivalent	Harleco