Product Code: JFJ FDA class 2 21 CFR 862.1070

Catalytic Methods, Amylase

Clinical Chemistry

Catalytic Methods for Amylase measurement are clinical chemistry test systems used to quantify amylase enzyme activity in serum or urine, supporting the diagnosis and monitoring of pancreatitis and other pancreatic or salivary gland disorders. They are classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification in addition to general and special controls. The product code is JFJ, regulated under 21 CFR 862.1070, within the Clinical Chemistry medical specialty. This device type is eligible for third-party 510(k) review.

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Basic Information

Product Code: JFJ
Device Class: FDA class 2
Regulation Number: 862.1070
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 99 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K210633	Amylase2	May 26, 2022	Substantially Equivalent	Abbott Ireland Diagnostics Division
K191454	Atellica CH Amylase_2 (AMY_2)	Jul 30, 2019	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K182474	alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL	May 02, 2019	Substantially Equivalent	Biosystems S.A.
K130685	HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY	Aug 09, 2013	Substantially Equivalent	Hitachi Chemical Diagnostics, Inc.
K122858	ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II	Oct 03, 2012	Substantially Equivalent	Elitechgroup
K091846	SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607	Oct 16, 2009	Substantially Equivalent	Beckman Coulter, Inc.
K080823	EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT	Nov 17, 2008	Substantially Equivalent	Medica Corp.
K070064	AMYLASE EPS REAGENT	May 22, 2007	Substantially Equivalent	Thermo Fisher Scientific
K062180	ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP	Oct 02, 2006	Substantially Equivalent	Horiba Abx
K051447	SENTINEL PANCREATIC AMYLASE	Jan 26, 2006	Substantially Equivalent	Sentinel Ch. Srl
K040920	AMYLASE LIQUID REAGENT, MODEL A532-200	May 10, 2004	Substantially Equivalent	Teco Diagnostics
K040534	VITALAB AMYLASE REAGENT	Mar 11, 2004	Substantially Equivalent	Clinical Data, Inc.
K023549	WIENER LAB AMILASA 405 AA LIQUIDA	Dec 09, 2002	Substantially Equivalent	Wiener Laboratories Saic
K020282	JAS AMYLASE LIQUID REAGENT	Feb 28, 2002	Substantially Equivalent	Jas Diagnostics, Inc.
K013978	SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT	Jan 15, 2002	Substantially Equivalent	Beckman Coulter, Inc.
K013101	WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA	Nov 16, 2001	Substantially Equivalent	Wiener Laboratories Saic
K011843	GENZYME DIRECT-AMYLASE TEST REAGENT	Aug 10, 2001	Substantially Equivalent	Genzyme Corp.
K011145	MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658	Jun 25, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K001569	INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)	Jun 26, 2000	Substantially Equivalent	Sigma Diagnostics, Inc.
K990025	CARESIDE AMYLASE	Feb 08, 1999	Substantially Equivalent	Careside, Inc.
K984184	WAKO L-TYPE AMYLASE	Jan 13, 1999	Substantially Equivalent	Wako Chemicals USA, Inc.
K981653	AMY	Aug 28, 1998	Substantially Equivalent	Abbott Laboratories
K981216	AMY	Jun 08, 1998	Substantially Equivalent	Abbott Laboratories
K974125	IL TEST AMYLASE	Dec 17, 1997	Substantially Equivalent	Instrumentation Laboratory CO
K974053	AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10	Dec 08, 1997	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K972250	ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS	Aug 12, 1997	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K971825	PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST	Jul 24, 1997	Substantially Equivalent	Randox Laboratories, Ltd.
K972297	AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)	Jul 17, 1997	Substantially Equivalent	Trace America, Inc.
K951548	ACE AMYLASE REAGENT	May 15, 1995	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K945243	CATALOGUE NUMBER 321-07/15/50	Feb 08, 1995	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K944229	OLYMPUS AMYLASE REAGENT	Dec 09, 1994	Substantially Equivalent	Olympus America, Inc.
K942961	AMYLASE QVET	Dec 09, 1994	Substantially Equivalent	Prisma Systems
K942640	DUPONT DIMENSION AMYLASE METHOD	Sep 09, 1994	Substantially Equivalent	Dupont Medical Products
K934293	BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT	Jul 06, 1994	Substantially Equivalent	Beckman-Diagnostic Systems Group
K941091	SYNERMED AMYLASE REAGENT KIT	May 03, 1994	Substantially Equivalent	Synermed, Inc.
K933682	DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS	Apr 12, 1994	Substantially Equivalent	Miles, Inc.
K930678	AMYLASE	Apr 06, 1994	Substantially Equivalent	Horizon Diagnostics, Inc.
K932888	INTERSECT SYSTEMS DIRECT AMYLASE REAGENT	Jan 31, 1994	Substantially Equivalent	Intersect Systems, Inc.
K931080	AMYLASE REAGENT SET (KINETIC)	Nov 05, 1993	Substantially Equivalent	Teco Diagnostics
K933397	GENZYME A-AMYLASE TEST REAGENT	Oct 28, 1993	Substantially Equivalent	Genzyme Corp.
K931583	SILYL AMYL	Aug 19, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K931582	ETHYLIDENE AMYL	Aug 19, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K930475	LIQUID AMYLASE REAGENT SET	Jul 19, 1993	Substantially Equivalent	Pointe Scientific, Inc.,
K923346	OLYMPUS AMYLASE REAGENT	Oct 02, 1992	Substantially Equivalent	Olympus Corp.
K923105	MILES URINE AMYLASE METHOD	Sep 28, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K923677	AMYLASE TEST	Sep 09, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K921057	AMYLASE REAGENT	Mar 27, 1992	Substantially Equivalent	Genzyme Corp.
K920583	ABBOTT QUICKSTART AMYLASE, #5AXX	Mar 02, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K913744	IL TEST(TM) AMLYLASE	Feb 18, 1992	Substantially Equivalent	Instrumentation Laboratory CO
K915710	AMYLASE (COLORIMETRIC) REAGENT SET	Jan 30, 1992	Substantially Equivalent	Tech Intl. Co.
K913858	AMYLASE REAGENT (PROCEDURE 577)	Sep 11, 1991	Substantially Equivalent	Sigma Diagnostics, Inc.
K912519	AMYLASE REAGENT	Jul 01, 1991	Substantially Equivalent	Genzyme Corp.
K910158	AMYLASE	Apr 30, 1991	Substantially Equivalent	Pointe Scientific, Inc.,
K905651	KINETIC AMYLASE DETERMINATION	Jan 31, 1991	Substantially Equivalent	Biochemical Trade, Inc.
K903309	ROCHE COBAS READY AMYLASE REAGENT	Sep 07, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K903332	SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404	Aug 17, 1990	Substantially Equivalent	Em Diagnostic Systems, Inc.
K902326	AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS	Jul 31, 1990	Substantially Equivalent	Catachem, Inc.
K901017	DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI	May 15, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K900230	COULTER AMYLASE REAGENT	Apr 03, 1990	Substantially Equivalent	Coulter Corp.
K896650	AMYLASE REAGENT	Feb 08, 1990	Substantially Equivalent	Sigma Chemical Co.
K893751	AMYLASE TEST (AML) ITEM NUMBER: 65404	Aug 17, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K891241	ABBOTT SPECTRUM AMYLASE REAGENT	Aug 15, 1989	Substantially Equivalent	Abbott Laboratories
K892848	PANCREATIC A-AMYLASE PNP	Jul 20, 1989	Substantially Equivalent	Boehringer Mannheim Corp.
K885176	AMYLASE SR LIQUID STABLE REAGENT SET	Feb 17, 1989	Substantially Equivalent	Medical Analysis Systems, Inc.
K880867	AMYLASE 405 CATALOG NUMBER 301-34	Apr 19, 1988	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K874704	REFLOTRON (R) AMYLASE	Jan 05, 1988	Substantially Equivalent	Boehringer Mannheim Corp.
K873944	A-GENT LIQUID AMYLASE	Nov 23, 1987	Substantially Equivalent	Abbott Laboratories
K873133	BNP-AMYLASE TEST	Oct 06, 1987	Substantially Equivalent	Sclavo, Inc.
K872023	AMYLASE TEST KIT	Aug 05, 1987	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K870746	STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715	Jun 01, 1987	Substantially Equivalent	Stanbio Laboratory
K871269	RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)	Apr 13, 1987	Substantially Equivalent	Technicon Instruments Corp.
K864825	AMYLASE COLORIMETRIC PROCEDURE	Feb 20, 1987	Substantially Equivalent	Data Medical Associates, Inc.
K864464	PSI AMYLASE REAGENT	Jan 21, 1987	Substantially Equivalent	Pointe Scientific, Inc.,
K864303	QKO (TM) AMYLASE B-HA	Dec 31, 1986	Substantially Equivalent	Wako Chemicals USA, Inc.
K864435	VISION(TM) AMYLASE	Dec 16, 1986	Substantially Equivalent	Abbott Laboratories
K863622	TDX(R) AMYLASE II	Oct 03, 1986	Substantially Equivalent	Abbott Laboratories
K863588	AMYLASE PROCEDURE	Sep 29, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K862733	AMYLASE SR LIQUID STABLE REAGENT SET	Sep 29, 1986	Substantially Equivalent	Medical Analysis Systems, Inc.
K861718	AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109	May 29, 1986	Substantially Equivalent	Reagents Applications, Inc.
K861269	RAICHEM AMYLASE REAGENT	May 29, 1986	Substantially Equivalent	Reagents Applications, Inc.
K860665	ALPHA-AMYLASE TEST	Apr 07, 1986	Substantially Equivalent	Sclavo, Inc.
K860918	EASY-TEST AMLASE (AMYL), #67521/93	Apr 03, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K860245	ENZYMATIC ALPHA-AMYLASE REAGENT KIT	Mar 14, 1986	Substantially Equivalent	Bio-Analytics Laboratories, Inc.
K852001	AMY REAGENT	Jun 10, 1985	Substantially Equivalent	Alpkem Corp.
K850798	AMYLASE PRODUCTS	Mar 14, 1985	Substantially Equivalent	Data Medical Associates, Inc.
K832889	AMYLASE	Nov 25, 1983	Substantially Equivalent	Pointe Scientific, Inc.,
K831561	AMYLAST-D TEST	Jul 07, 1983	Substantially Equivalent	Sclavo, Inc.
K831536	PARAMAX AMALINE REAGENT	Jun 17, 1983	Substantially Equivalent	American Dade
K823462	SINGLE VIAL AMYLASE PNP TEST	Dec 28, 1982	Substantially Equivalent	Boehringer Mannheim Corp.
K821869	ULTRAZYME PLUS AMYL	Jul 13, 1982	Substantially Equivalent	Harleco Diagnostics
K821459	ULTRAZYME PLUS AMYL #65031&64982	May 28, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K802581	BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY	Nov 12, 1980	Substantially Equivalent	Beckman Instruments, Inc.
K801295	COBAS REAGENT FOR A-AMYLASE	Jul 08, 1980	Substantially Equivalent	Roche Analytical Instruments, Inc.
K800049	DELTA TEST AMYLASE UV	Jan 23, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K772035	GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL	Nov 17, 1977	Substantially Equivalent	Harleco
K771622	MULTISTAT III, AMYLASE TEST	Sep 13, 1977	Substantially Equivalent	Instrumentation Laboratory CO
K771388	AMYLASE ULTRAZYME PLUS	Sep 02, 1977	Substantially Equivalent	Harleco
K771131	CLINICARD UV AMYLASE CHEMISTRY	Jul 21, 1977	Substantially Equivalent	Harleco
K770750	REAGENT KIT, ENZYMATIC AMYLASE	Jul 05, 1977	Substantially Equivalent	Beckman Instruments, Inc.