Product Code: JIS FDA class 2 21 CFR 862.1150

Calibrator, Primary

Clinical Chemistry

This device is a primary calibrator used in clinical chemistry laboratory analyzers to establish an accurate reference baseline for quantitative test measurements, ensuring that analytical instruments produce results traceable to accepted reference standards. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before marketing. The product code is JIS, regulated under 21 CFR 862.1150, and belongs to the Clinical Chemistry medical specialty.

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510(k)s

130

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JIS
Device Class: FDA class 2
Regulation Number: 862.1150
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

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 130 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K122126	DIRECT LDL/HDL CHOLESTEROL CALIBRATOR	Aug 14, 2012	Substantially Equivalent	Randox Laboratories Limited
K061251	DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR	May 31, 2006	Substantially Equivalent	Dade Behring, Inc.
K060266	DIMENSION IRON CALIBRATOR	Mar 09, 2006	Substantially Equivalent	Dade Behring, Inc.
K053104	DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR	Dec 23, 2005	Substantially Equivalent	Dade Behring, Inc.
K032697	DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)	Nov 07, 2003	Substantially Equivalent	Dade Behring, Inc.
K032608	GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER	Oct 21, 2003	Substantially Equivalent	Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB
K032296	VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS	Aug 13, 2003	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K030964	CALIBRATION PLASMA LMW HEPARIN	Jun 06, 2003	Substantially Equivalent	Instrumentation Laboratory CO
K030546	CRP (II) CALIBRATORS	Jun 02, 2003	Substantially Equivalent	Denka Seiken Co., Ltd.
K030320	WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET	Apr 11, 2003	Substantially Equivalent	Wako Chemicals USA, Inc.
K022682	RANDOX C-REACTIVE PROTEIN CALIBRATOR	Nov 05, 2002	Substantially Equivalent	Randox Laboratories, Ltd.
K022901	VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS	Sep 27, 2002	Substantially Equivalent	Ortho-Clinical Diagnostics
K013126	N LP(A) STANDARD SY	Nov 09, 2001	Substantially Equivalent	Dade Behring, Inc.
K012878	THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609	Oct 16, 2001	Substantially Equivalent	Thermo Dma, Inc.
K011568	RANDOX LIPOPROTEIN	Sep 28, 2001	Substantially Equivalent	Randox Laboratories, Ltd.
K010696	BECKMAN COULTER DNASE B CALIBRATOR	May 10, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K003941	ELECSYS HCG STAT CLASET II	Jan 25, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K003969	ELECSYS CA 125 II CALSET	Jan 12, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K002760	ELECSYS DHEA-S CALSET	Oct 05, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K002353	ELECSYS CA 15-3 CALCHECK	Aug 10, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K001906	ELECSYS INSULIN CALSET	Jul 13, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K001005	WAKO HDL-C/LDL-C CALIBRATOR	Jun 01, 2000	Substantially Equivalent	Wako Chemicals USA, Inc.
K001004	WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR	Jun 01, 2000	Substantially Equivalent	Wako Chemicals USA, Inc.
K001002	WAKO LIPASE CALIBRATOR	May 24, 2000	Substantially Equivalent	Wako Chemicals USA, Inc.
K000331	SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR	Feb 10, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K994169	SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR	Feb 03, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K994168	SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR	Feb 03, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K994114	DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR	Jan 20, 2000	Substantially Equivalent	Dade Behring, Inc.
K994325	SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR	Jan 12, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K994145	VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS	Dec 22, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K993219	WAKO BILIRUBIN CALIBRATOR	Nov 09, 1999	Substantially Equivalent	Wako Chemicals USA, Inc.
K983640	SYNCHRON SYSTEMS LIPID CALIBRATOR	Dec 21, 1998	Substantially Equivalent	Beckman Coulter, Inc.
K970933	AUTO HDL CHOLESTEROL CALIBRATOR	May 23, 1997	Substantially Equivalent	Pointe Scientific, Inc.,
K963847	WAKO DIRECT HDL-C	Dec 24, 1996	Substantially Equivalent	Wako Chemicals USA, Inc.
K964475	CLINICAL BLOOD GAS MIXTURES	Dec 06, 1996	Substantially Equivalent	Oxarc, Inc.
K954546	BLOOD GAS MIXTURE	Dec 28, 1995	Substantially Equivalent	Liquid Technology Corp.
K951964	SYNCHRON ENZYME VALIDATOR SET	Jun 29, 1995	Substantially Equivalent	Beckman Instruments, Inc.
K951585	T-UPTAKE CALIBRATORS	Jun 15, 1995	Substantially Equivalent	Diagnostic Reagents, Inc.
K951629	IMX ESTRADIOL	May 17, 1995	Substantially Equivalent	Abbott Laboratories
K944701	CALIBRATORS	Nov 21, 1994	Substantially Equivalent	Diagnostic Reagents, Inc.
K940008	GLYCATED PROTEIN CALIBRATORS	May 09, 1994	Substantially Equivalent	Primus Corp.
K936201	URINARY ALBUMIN CALIBRATOR	Mar 11, 1994	Substantially Equivalent	Dupont Medical Products
K931834	KING SODIUM/POTASSIUM STANDARD MODIFIED	Aug 25, 1993	Substantially Equivalent	King Diagnostics, Inc.
K932555	DC-LINEATE CAT. NO. SE-091	Aug 19, 1993	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K930501	DU PONT ACA NEV/EEV VERIFIER	Aug 09, 1993	Substantially Equivalent	Dupont Medical Products
K922646	REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM	Jun 25, 1993	Substantially Equivalent	Behring Diagnostics, Inc.
K930477	ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR	Jun 07, 1993	Substantially Equivalent	Analytical Control Systems, Inc.
K925877	DC-UIBC-CAL	Mar 18, 1993	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K924904	HDL-CHOLESTEROL STANDARD, MODIFICATION	Jan 13, 1993	Substantially Equivalent	Verichem Laboratories, Inc.
K922699	DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR	Sep 23, 1992	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K922698	DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR	Sep 09, 1992	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K922696	DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO	Aug 12, 1992	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K921855	BIOTROL BICARBONATE STANDARDS	Aug 03, 1992	Substantially Equivalent	Biotrol, USA, Inc.
K921903	THYROXINE CALIBRATOR KIT	May 26, 1992	Substantially Equivalent	Tudor Laboratories, Inc.
K920809	KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD	Apr 17, 1992	Substantially Equivalent	King Diagnostics, Inc.
K910721	BIOTROL PROTEIN MULTILEVEL STANDARDS	May 06, 1991	Substantially Equivalent	Biotrol, USA, Inc.
K905820	ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI	Feb 26, 1991	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K905477	OLYMPUS URINE PH CALIBRATORS LEVELS I AND II	Feb 13, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K901113	MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD	Mar 29, 1990	Substantially Equivalent	Verichem Laboratories, Inc.
K895778	QUANTIMETRIX BILIRUBIN CALIBRATORS	Nov 14, 1989	Substantially Equivalent	Quantimetrix Medical Industries
K895585	HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)	Nov 13, 1989	Substantially Equivalent	Hichem Diagnostics
K884168	ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.	Nov 29, 1988	Substantially Equivalent	The DU Pont Co.
K882726	RAICHEM(TM) BILIRUBIN STANDARD	Aug 29, 1988	Substantially Equivalent	Reagents Applications, Inc.
K881693	TERUMO SENSIBEAD EIA PROGESTERONE KIT	Jun 07, 1988	Substantially Equivalent	Terumo Medical Corp.
K872051	CALCIUM CALIBRATOR	Sep 18, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K871188	LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086	May 28, 1987	Substantially Equivalent	In Vitro Diagnostics, Inc.
K871187	LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084	May 28, 1987	Substantially Equivalent	In Vitro Diagnostics, Inc.
K871186	CESIUM DILUENT 1.5 MMOL CS/L #60087	May 28, 1987	Substantially Equivalent	In Vitro Diagnostics, Inc.
K871185	LITHIUM INTERNAL STANDARD 1 MEQ/L #60085	May 28, 1987	Substantially Equivalent	In Vitro Diagnostics, Inc.
K870379	ISE COMPENSATION SERA	Feb 26, 1987	Substantially Equivalent	Boehringer Mannheim Corp.
K862704	EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95	Aug 19, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K862453	EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93	Aug 19, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K861891	TOBRAMYCIN (FPIA) CALIBRATOR KIT	Jun 25, 1986	Substantially Equivalent	Windsor Laboratories, Inc.
K861770	PHENYTOIN (FPIA) CALIBRATOR KIT	Jun 25, 1986	Substantially Equivalent	Windsor Laboratories, Inc.
K861769	GENTAMICIN (FPIA) CALIBRATOR KIT	Jun 25, 1986	Substantially Equivalent	Windsor Laboratories, Inc.
K861768	THEOPHYLLINE (FPIA) CALIBRATOR KIT	Jun 25, 1986	Substantially Equivalent	Windsor Laboratories, Inc.
K855040	SERALYZER TOTAL BILIRUBIN CALIBRATORS	Jan 22, 1986	Substantially Equivalent	Miles Laboratories, Inc.
K852068	TOTAL BILIRUBIN STANDARDS	May 31, 1985	Substantially Equivalent	Data Medical Associates, Inc.
K844581	80 MG/DL GLUCOSE CONTROL	Dec 12, 1984	Substantially Equivalent	Boehringer Mannheim Corp.
K844235	CHLORIDE STANDARD	Nov 20, 1984	Substantially Equivalent	Shaban Mfg. Co.
K843110	ROCHE STANDARDS FOR CHOLESTEROL	Sep 04, 1984	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K842450	HICHEM ION 2/4 URINE RANGE CALIBRATOR	Aug 16, 1984	Substantially Equivalent	Hi Chem, Inc.
K842449	HICHEM ION 2/4 SERUM RANGE CALIBRATOR	Aug 16, 1984	Substantially Equivalent	Hi Chem, Inc.
K841955	DUPONT ACA MAGNESIUM CALIBRATOR	Jun 25, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K840299	PH ELECTRODE CALIBRATING BUFFERS-BLOOD	Mar 23, 1984	Substantially Equivalent	Bionostics, Inc.
K840220	HDL CHOLESTEROL AQUEOUS STANDARDS	Mar 23, 1984	Substantially Equivalent	Preventive Diagnostics Corp.
K840217	CHOLESTEROL AQUEOUS STANDARD	Mar 23, 1984	Substantially Equivalent	Preventive Diagnostics Corp.
K832251	PRECISET CHOLESTEROL HIGH PERFORM	Aug 24, 1983	Substantially Equivalent	Boehringer Mannheim Corp.
K830283	LITHIUM DILUENT	Feb 28, 1983	Substantially Equivalent	Shaban Mfg. Co.
K830137	CALIBRATOR A	Feb 07, 1983	Substantially Equivalent	Hi Chem, Inc.
K823147	URIC ACID STANDARD, 8MG/DL #65078	Nov 22, 1982	Substantially Equivalent	Harleco Diagnostics
K822477	CREATININE STANDARD #65072	Sep 17, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K822473	CALCIUM STANDARD, ITEM #65075	Sep 17, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K822476	PHOSPHOROUS STANDARD #65073	Sep 14, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K822474	CHOLESTEROL STANDARD #65077	Sep 14, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K822332	C-REACTIVE PROTEIN TEST KIT	Aug 16, 1982	Substantially Equivalent	Sclavo, Inc.
K822232	ACA URINARY PROTEIN CALIBRATOR	Aug 16, 1982	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K821934	BIO-CAL OPERATION CHECK KIT	Jul 20, 1982	Substantially Equivalent	Bio-Analytics Laboratories, Inc.
K821938	SYVA ADVANCE STANDARDIZATION KIT #3	Jul 16, 1982	Substantially Equivalent	Syva Co.
K821937	SYVA ADVANCE STANDARDIZATION KIT #2	Jul 16, 1982	Substantially Equivalent	Syva Co.
K821813	BECKMAN URIC ACID STANDARD	Jul 02, 1982	Substantially Equivalent	Beckman Instruments, Inc.
K821061	ACE ALBUMIN CALIBRATOR	May 03, 1982	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K820698	SYVA ADVANCE STANDARDIZATION KIT 01	Apr 01, 1982	Substantially Equivalent	Syva Co.
K813505	FLAME PHOTOMETER CALIBRATION STANDARDS	Dec 31, 1981	Substantially Equivalent	Fisher Scientific Co., LLC
K813447	SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR	Dec 31, 1981	Substantially Equivalent	Rna Medical Corp.
K813478	TRIGLYCERIDE CALIBRATORS	Dec 22, 1981	Substantially Equivalent	Gilford Diagnostics
K812861	CHOLESTEROL CALIBRATORS	Oct 23, 1981	Substantially Equivalent	Gilford Diagnostics
K810963	BIO SET TM SUBSTRATE CALIBRATORS	Apr 17, 1981	Substantially Equivalent	Boehringer Mannheim Corp.
K810867	FOLLICLE STIMULATING HORMONE (FSH)	Apr 14, 1981	Substantially Equivalent	Pcl-Ria, Inc.
K810743	LECITHIN-SPINGOMYELIN STAND. & KITS	Mar 31, 1981	Substantially Equivalent	Supelco, Inc.
K810742	AQUEOUS TRIOLEIN STANDARDS & KITS	Mar 31, 1981	Substantially Equivalent	Supelco, Inc.
K810618	AMPULED FLAME PHOTOMETER STANDARDS	Mar 31, 1981	Substantially Equivalent	United Diagnostics, Inc.
K810587	EMIT-TFG PRISMA THYROXINE CALIBRATORS	Mar 24, 1981	Substantially Equivalent	Syva Co.
K810092	CHOLESTEROL STANDARD	Feb 02, 1981	Substantially Equivalent	Anco Medical Reagents & Assoc.
K810091	GLUCOSE STANDARD	Jan 26, 1981	Substantially Equivalent	Anco Medical Reagents & Assoc.
K802631	CREATININE STANDARDS	Dec 11, 1980	Substantially Equivalent	Gilford Diagnostics
K801501	UV URIC ACID STANDARDS	Sep 26, 1980	Substantially Equivalent	The Dow Chemical Co.
K801665	SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH)	Aug 20, 1980	Substantially Equivalent	Miles Laboratories, Inc.
K801287	EMIT AAII THYROXINE CALIBRATORS	Jun 30, 1980	Substantially Equivalent	Syva Co.
K800588	NSI CALIBRATOR SET	Apr 04, 1980	Substantially Equivalent	Nobel Scientific Industries, Inc.
K800206	ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT.	Mar 03, 1980	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K800062	PIPET CALIBRATION KIT	Feb 11, 1980	Substantially Equivalent	Streck Laboratories, Inc.
K800042	LITHIUM STANDARD (1MM/L)	Jan 21, 1980	Substantially Equivalent	Gilford Diagnostics
K792046	URIC ACID STANDARD	Oct 30, 1979	Substantially Equivalent	Gilford Diagnostics
K791315	SPECTRO-SUR SET	Aug 16, 1979	Substantially Equivalent	Helena Laboratories
K781853	CHOLESTEROL STANDARDS	Dec 04, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K780467	EMIT ANTIEPILEPTIC DRUG CALIBRATORS	Apr 24, 1978	Substantially Equivalent	Syva Co.
K772025	URIC ACID STD. FOR QUANT. URIC ACID	Nov 11, 1977	Substantially Equivalent	Worthington Biochemical Corp.
K770072	BIO TROL-T TRIOLEIN SOLUTIONS	Jan 26, 1977	Substantially Equivalent	Boehringer Mannheim Corp.
K760806	REFEREE AQUEOUS TRIGLYCERIDE STND	Oct 21, 1976	Substantially Equivalent	Analytical Products, Inc.