Product Code: CJE FDA class 2 21 CFR 862.1050

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Clinical Chemistry

The Nitrophenylphosphate, Alkaline Phosphatase or Isoenzymes test system (product code CJE) is an in-vitro diagnostic device used in clinical chemistry to measure alkaline phosphatase activity or its isoenzymes in serum using para-nitrophenyl phosphate as a chromogenic substrate, a standard photometric method widely used in automated clinical analyzers. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1050 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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510(k)s

124

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CJE
Device Class: FDA class 2
Regulation Number: 862.1050
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 124 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251074	Tru Liver Health Test Panel	Dec 19, 2025	Substantially Equivalent	Truvian Health
K240468	Alkaline Phosphatase	Oct 16, 2024	Substantially Equivalent	Abbott Laboratories Diagnostics Division
K223317	Alkaline Phosphatase2	Jul 21, 2023	Substantially Equivalent	Abbott Ireland Diagnostics Division
K191245	Yumizen C1200 ALP, Yumizen C1200 Albumin	Aug 30, 2019	Substantially Equivalent	HORIBA ABX SAS
K171971	Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer	Jan 25, 2018	Substantially Equivalent	Lite-On Technology Corp. H.S.P.B.
K171080	ALP IFCC Gen.2	May 10, 2017	Substantially Equivalent	Roche Diagnostics Operations (Rdo)
K162275	Randox RX Daytona Plus Alkaline Phosphatase (ALP)	Apr 21, 2017	Substantially Equivalent	Randox Laboratories Limited
K131351	ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT	Aug 15, 2013	Substantially Equivalent	Alfa Wassermann Diagnostic Technologies, LLC
K130141	S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)	Mar 22, 2013	Substantially Equivalent	Hitachi Chemical Diagnostics, Inc.
K113436	ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT	Jul 12, 2012	Substantially Equivalent	Alfa Wassermann
K113269	ELITTECH CLINICAL SYSTEMS ALP IFCC SL	Dec 29, 2011	Substantially Equivalent	Elitechgroup
K101090	EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS	May 20, 2011	Substantially Equivalent	Medica Corp.
K073191	ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL	Feb 28, 2008	Substantially Equivalent	Thermofisher Scientific OY
K060205	GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER	Jul 21, 2006	Substantially Equivalent	Horiba Abx
K033185	COBAS INTEGRA ALP IFCC GEN.2	Oct 14, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K023807	MODIFICATION TO ALKP	Dec 26, 2002	Substantially Equivalent	Abbott Laboratories
K013983	WIENER LAB. ALP 405	Jan 28, 2002	Substantially Equivalent	Wiener Laboratories Saic
K012518	TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113	Oct 09, 2001	Substantially Equivalent	Thermo Dma, Inc.
K011599	ALKALINE PHOSPHATASE LIQUID REAGENT	Jul 20, 2001	Substantially Equivalent	Jas Diagnostics, Inc.
K003093	ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30	Nov 27, 2000	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K002285	ATAC PAK ALP REAGENT KIT	Sep 26, 2000	Substantially Equivalent	Elan Diagnostics
K000067	ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H	Jan 20, 2000	Substantially Equivalent	Teco Diagnostics
K991762	ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02	Sep 02, 1999	Substantially Equivalent	A.P. Total Care, Inc.
K991387	ELAN ALKALINE PHOSPHATE REAGENT KIT	May 19, 1999	Substantially Equivalent	Elan Holdings, Inc.
K990024	CARESIDE ALKALINE PHOSPHATASE	Jan 13, 1999	Substantially Equivalent	Careside, Inc.
K981897	ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE	Aug 26, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K981806	ALKP	Jun 22, 1998	Substantially Equivalent	Abbott Laboratories
K981245	ALKALINE PHOSPHATASE (ALKP)	May 20, 1998	Substantially Equivalent	Abbott Laboratories
K980316	ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30	Feb 12, 1998	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K973588	LIQUID ALKALINE PHOSHATASE REAGENT SET	Oct 22, 1997	Substantially Equivalent	Pointe Scientific, Inc.,
K971463	ALP REAGENT SET	May 16, 1997	Substantially Equivalent	Carolina Liquid Chemistries Corp.
K964914	ALKALINE PHOSPHATASE	Feb 04, 1997	Substantially Equivalent	Derma Media Lab., Inc.
K954840	ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245	Feb 28, 1996	Substantially Equivalent	Sigma Diagnostics, Inc.
K952746	ALKALINE PHOSPHATASE REAGENT SYSTEM	Nov 27, 1995	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K951584	ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247	Aug 11, 1995	Substantially Equivalent	Sigma Diagnostics, Inc.
K942997	ALKALINE PHOSPHATASE (ALKP) QVET	Dec 29, 1994	Substantially Equivalent	Prisma Systems
K941313	STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET	May 17, 1994	Substantially Equivalent	Stanbio Laboratory
K935182	EMDS ALKANINE PHOSPHATASE (ALP) TEST	Dec 09, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K931986	AMP ALKALINE PHOSPHATASE REAGENT KIT	Sep 08, 1993	Substantially Equivalent	Synermed, Inc.
K923507	ALKALINE PHOSPHATASE KIT	Dec 03, 1992	Substantially Equivalent	Randox Laboratories, Ltd.
K925156	OLYMPUS ALKALINE PHOSPHATASE REAGENT	Nov 18, 1992	Substantially Equivalent	Olympus Corp.
K924574	EMDS ALKALINE PHOSPHATASE (ALP) TEST	Nov 09, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K923527	OLYMPUS ALKALINE PHOSPHATASE REAGENT	Sep 28, 1992	Substantially Equivalent	Olympus Corp.
K913921	ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38	Nov 22, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K910639	SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483	Apr 12, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K905650	KINETIC ALKALINE PHOSPHATASE DETERMINATION	Feb 13, 1991	Substantially Equivalent	Biochemical Trade, Inc.
K905684	ALKALINE PHOSPHATASE	Dec 28, 1990	Substantially Equivalent	Amresco, Inc.
K904030	SYNERMED ALKALINE PHOSPHATASE REAGENT KIT	Sep 27, 1990	Substantially Equivalent	Synermed, Inc.
K902560	ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT	Jul 17, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K900250	AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781	Mar 01, 1990	Substantially Equivalent	American Research Products Co.
K900216	COULTER ALP (ALK PHOS) REAGENT	Feb 08, 1990	Substantially Equivalent	Coulter Corp.
K895250	SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402	Oct 31, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K890521	ABBOTT CLINICAL CHEMISTRY REAGENT ALP	Mar 24, 1989	Substantially Equivalent	Abbott Laboratories
K884549	ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651	Nov 10, 1988	Substantially Equivalent	Em Diagnostic Systems, Inc.
K881742	BIOTROL ALKALINE PHOSPHATASE	Jul 08, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K880796	ALKALINE PHOSPHATASE REAGENT, DEA BUFF	Apr 18, 1988	Substantially Equivalent	Trace America, Inc.
K880795	RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.	Apr 18, 1988	Substantially Equivalent	Trace America, Inc.
K880307	ALKALINE PHOSPHATASE REAGENT SET	Mar 15, 1988	Substantially Equivalent	Tech-Neal Scientific, Inc.
K875210	ALKALINE PHOSPHATASE CAT. # 306-22, 306-23	Feb 02, 1988	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K873635	EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021	Oct 29, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K873761	MULTICHEM ALKALINE PHOSPHATASE (S0903)	Oct 07, 1987	Substantially Equivalent	Simmler, Inc.
K873333	WAKO(TM) AUTOKIT ALP	Oct 02, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K873681	ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95	Sep 29, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K871543	ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.	Jun 22, 1987	Substantially Equivalent	Catachem, Inc.
K864905	ALKALINE PHOSPHATASE	Jan 13, 1987	Substantially Equivalent	Tech-Co, Inc.
K863980	U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST	Dec 04, 1986	Substantially Equivalent	U. S. Diagnostics, Inc.
K863268	ALKALINE PHOSPHATASE PROCEDURE	Sep 29, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K862498	ALKALINE PHOSPHATASE TEST	Sep 26, 1986	Substantially Equivalent	King Diagnostics, Inc.
K863051	ALP S.C.E.	Sep 09, 1986	Substantially Equivalent	J. D. Assoc.
K862905	ALP (OPT) REAGENT	Aug 29, 1986	Substantially Equivalent	Sigma Diagnostics, Inc.
K862256	ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET	Jul 01, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K861667	ALKALINE PHOSPHATASE PROCEDURE	May 29, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K861638	KINETIC ALKALINE PHOSPHATASE REAGENT KIT	May 29, 1986	Substantially Equivalent	Bio-Analytics Laboratories, Inc.
K861284	AP REAGENT CARTRIDGE	Apr 28, 1986	Substantially Equivalent	Hi Chem, Inc.
K860715	ALP (ALKALINE PHOSPHATASE) REAGENT	Apr 24, 1986	Substantially Equivalent	Trace Scientific , Ltd.
K860134	EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT	Feb 06, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K852441	IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN	Aug 21, 1985	Substantially Equivalent	Clinical Data, Inc.
K852752	AMRESCO FLOW PAC ALKALINE PHOSPHATASE BUFFER CONCE	Jul 23, 1985	Substantially Equivalent	American Research Products Co.
K852784	ALKALINE PHOSPHATASE	Jul 22, 1985	Substantially Equivalent	Advanced Biomedical Methods, Inc.
K851998	ALP(ALKALINE)(PHOSPHATASE) REAGENT	May 30, 1985	Substantially Equivalent	Alpkem Corp.
K850110	VISION -FORMERLY PDA- ALKALINE PHOSPHATASE	Jan 29, 1985	Substantially Equivalent	Abbott Laboratories
K843332	ALKALINE PHOSPHATASE REAGENT SET	Sep 14, 1984	Substantially Equivalent	Sterling Biochemical, Inc.
K843270	SYSTEMATE ALKALINE PHOSPHATASE-67203	Sep 13, 1984	Substantially Equivalent	Em Diagnostic Systems, Inc.
K842243	ALKALINE PHOSPHATASE ASSAY KIT	Jul 18, 1984	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K841918	SIGMA PROCED. 245 ALKALINE PHOSPHATASE	Jun 14, 1984	Substantially Equivalent	Sigma Diagnostics, Inc.
K834033	KINETIC ALKALINE PHOSPHATASE	Jan 30, 1984	Substantially Equivalent	American Monitor Corp.
K833744	ALKALINE PHOSPHATASE-RATE	Jan 13, 1984	Substantially Equivalent	Seragen Diagnostics, Inc.
K832463	RAICHEM ALKALINE PHOSPHATASE REAGENT	Sep 12, 1983	Substantially Equivalent	Reagents Applications, Inc.
K831480	PARAMAX ALKALINE PHOSPHATASE REAGENT-	Jun 22, 1983	Substantially Equivalent	American Dade
K831360	DATA-ZYME ALKALINE PHOSPHATASE PROCED	Jun 08, 1983	Substantially Equivalent	Data Medical Associates, Inc.
K823786	ALKALINE PHOSPHATASE	Jan 14, 1983	Substantially Equivalent	Analytical & Research Chemicals, Inc.
K823213	DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI	Nov 22, 1982	Substantially Equivalent	Boehringer Mannheim Corp.
K821870	ULTRAZYME PLUS ALP	Jul 13, 1982	Substantially Equivalent	Harleco Diagnostics
K821471	ULTRAZYME PLUS ALP #64962,65029&65030	Jun 02, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K812912	GILCHEM ALP REAGENT	Nov 02, 1981	Substantially Equivalent	Gilford Diagnostics
K812596	ULTRA ZYME PLUS ALP #64962, 65029 & 30	Sep 29, 1981	Substantially Equivalent	Harleco
K812452	ALKALINE PHOSPHATASE	Sep 09, 1981	Substantially Equivalent	Pointe Scientific, Inc.,
K810082	ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT	Jan 26, 1981	Substantially Equivalent	Bio-Analytics Laboratories, Inc.
K802574	BECKMAN LIQUID STAT LIQUID/ALKALINE PHO	Nov 12, 1980	Substantially Equivalent	Beckman Instruments, Inc.
K801242	COBAS REAGENT FOR ALKALINE PHOSPHATASE	Jun 20, 1980	Substantially Equivalent	Roche Analytical Instruments, Inc.
K800679	REAGENTS FOR DETERM. ALKALINE PHOSPHATAS	May 28, 1980	Substantially Equivalent	Diagnostic Solutions, Inc.
K800131	CENTRIFICHEM ALP/ALKALINE PHOSPHATASE	Feb 11, 1980	Substantially Equivalent	Union Carbide Corp.
K792413	ELVI ALKALINE PHOSPHATATASE	Dec 07, 1979	Substantially Equivalent	Volu Sol Medical Industries
K790065	ALKALINE PHOSPHATASE	Feb 21, 1979	Substantially Equivalent	Macomb Chemical Co.
K781718	ALP REAGENT SET, ALKALINE PHOSPHATASE	Nov 03, 1978	Substantially Equivalent	Medical Analysis Systems, Inc.
K781609	ALKALINE PHOSPHATASE IN SERUM	Oct 24, 1978	Substantially Equivalent	Fisher Scientific Co., LLC
K781472	MITROPHENYL, ALKALINE PHOSPHATES	Sep 27, 1978	Substantially Equivalent	Beckman Instruments, Inc.
K780095	ULTRAZYME PLUS ALP	Feb 13, 1978	Substantially Equivalent	Harleco
K780068	ALP REAGENT SET	Feb 07, 1978	Substantially Equivalent	Medical Analysis Systems, Inc.
K772032	GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP	Nov 17, 1977	Substantially Equivalent	Harleco
K771829	ALKALINE PHOSPHATASE	Nov 02, 1977	Substantially Equivalent	Gamma Enterprises, Inc.
K771695	ALKALINE PHOSPHATASE TEST	Oct 18, 1977	Substantially Equivalent	Sclavo, Inc.
K771470	MULTISTAT III ALKALINE PHOSPHATASE	Sep 12, 1977	Substantially Equivalent	Instrumentation Laboratory CO
K771085	DYNAZYME II ALKALINE PHOSPHATASE	Aug 04, 1977	Substantially Equivalent	J.T. Baker Chemical Co.
K770870	ULTRAZYME PLUS ALP	Jul 14, 1977	Substantially Equivalent	Harleco
K770406	TECHNICON SMA & AAII SYSTEMS	Jun 02, 1977	Substantially Equivalent	Boehringer Laboratories
K770316	ALKALINE PHOSPHATASE ENZYMATIC	Mar 30, 1977	Substantially Equivalent	Icn Pharmaceuticals, Inc.
K761315	ALKALINE PHOSPHATASE (ALP)/PNPP	Feb 24, 1977	Substantially Equivalent	Princeton Biomedix
K760685	SIGMA PROCED #SC165	Nov 24, 1976	Substantially Equivalent	Sigma Chemical Co.
K760397	REAGENT, AMP BUFFER DIAGNOSTIC	Nov 01, 1976	Substantially Equivalent	J.T. Baker Chemical Co.
K760474	REAGENT, ALKALINE PHOSPHATASE DETERM.	Oct 29, 1976	Substantially Equivalent	Simmler & Son, Inc.
K760398	REAGENT, MAGNESIUM CHLORIDE	Oct 29, 1976	Substantially Equivalent	J.T. Baker Chemical Co.
K760399	REAGENT, P-NITROPHENYL PHOSPHATE	Aug 26, 1976	Substantially Equivalent	J.T. Baker Chemical Co.
K760024	ULTRAZYME ALKALINE PHOSPHATASE	Aug 26, 1976	Substantially Equivalent	Harleco