Product Code: CIJ FDA class 2 21 CFR 862.1070

Saccharogenic, Amylase

Clinical Chemistry

The Saccharogenic, Amylase test system (product code CIJ) is an in-vitro diagnostic device used in clinical chemistry to measure amylase enzyme activity in serum or urine using a saccharogenic method that quantifies reducing sugars released from starch substrate, supporting the diagnosis of pancreatitis and salivary gland disorders. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1070 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

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: CIJ
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

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 31 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K023396	AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)	Dec 23, 2002	Substantially Equivalent	Pointe Scientific, Inc.,
K991817	ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM	Jul 22, 1999	Substantially Equivalent	Bayer Corp.
K980013	AMYLASE	Feb 04, 1998	Substantially Equivalent	Ac Biochemicals, Inc.
K953211	AMYLASE (ETHYLIDENE PNGPG7) KIT	Jun 21, 1996	Substantially Equivalent	Randox Laboratories, Ltd.
K951494	AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)	Dec 11, 1995	Substantially Equivalent	Emd Chemicals, Inc.
K940735	LIQUID AMYLASE (CNPG3) REAGENT SET	Aug 01, 1994	Substantially Equivalent	Pointe Scientific, Inc.,
K940010	DMA AMYLASE (DEMAND) PROCEDURE	Mar 11, 1994	Substantially Equivalent	Data Medical Associates, Inc.
K931301	OLYMPUS AMYLASE REAGENT	Oct 18, 1993	Substantially Equivalent	Olympus Corp.
K931141	BIOTROL AMYLASE CNPG3	May 26, 1993	Substantially Equivalent	Biotrol, USA, Inc.
K882225	-AMYLASE EPS	Jan 03, 1989	Substantially Equivalent	Boehringer Mannheim Corp.
K873572	IL 35260, IL TEST AMYLASE REAGENT	Oct 20, 1987	Substantially Equivalent	Instrumentation Laboratory CO
K873250	ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL	Oct 20, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K872831	BIOTROL ALPHA AMYLASE	Sep 04, 1987	Substantially Equivalent	Biotrol, USA, Inc.
K871943	D.A.T. (TM) AMYLASE REAGENT	Jun 03, 1987	Substantially Equivalent	Behring Diagnostics, Inc.
K864356	AMYLASE REAGENT	Jan 21, 1987	Substantially Equivalent	Trace Scientific , Ltd.
K863719	AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1	Nov 13, 1986	Substantially Equivalent	Technicon Instruments Corp.
K862370	DART AMYLASE-D.S. REAGENT SYSTEM	Aug 01, 1986	Substantially Equivalent	Coulter Electronics, Inc.
K861664	AMYLASE PROCEDURE	Jul 01, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K860935	EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95	May 23, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K853951	ISOTRAK AMYLASE TEST AMYLASE ISOENZYME	Jan 07, 1986	Substantially Equivalent	Behring Diagnostics, Inc.
K852636	X-AMYLASE ASSAY KIT	Jul 12, 1985	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K843645	SYSTEMATE A AMYLASE HEM 67204	Sep 28, 1984	Substantially Equivalent	Em Diagnostic Systems, Inc.
K834053	DART ALPHA-AMYLASE REAGENT SYSTEM	Feb 04, 1984	Substantially Equivalent	Coulter Electronics, Inc.
K813529	DADE COLORIMETRIC AMYLASE	Dec 31, 1981	Substantially Equivalent	American Dade
K812594	ULTRA ZYME PLUS AMYL #64982 & 65031	Oct 02, 1981	Substantially Equivalent	Harleco
K792479	CHEM-STRATE AMYLASE	Dec 27, 1979	Substantially Equivalent	General Diagnostics
K790474	SZAMYL 6.5	May 01, 1979	Substantially Equivalent	Worthington Diagnostic Systems
K780513	ULTRA ZYME PLUS AMYL 64982, GILFORD 3500	May 19, 1978	Substantially Equivalent	Harleco
K780141	ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI.	Mar 09, 1978	Substantially Equivalent	Harleco
K760415	ENZYMATIC AMYLASE REAGENT KIT	Nov 05, 1976	Substantially Equivalent	Beckman Instruments, Inc.
K760026	ULTRAZYME AMYLASE	Sep 21, 1976	Substantially Equivalent	Harleco