Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1070](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1070) → CIJ — Saccharogenic, Amylase # CIJ · Saccharogenic, Amylase _Clinical Chemistry · 21 CFR 862.1070 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ ## Overview - **Product Code:** CIJ - **Device Name:** Saccharogenic, Amylase - **Regulation:** [21 CFR 862.1070](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1070) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) - **3rd-party reviewable:** yes ## Identification An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 31) Showing 20 most recent of 31 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K023396](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K023396.md) | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) | Pointe Scientific, Inc., | Dec 23, 2002 | SESE | | [K991817](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K991817.md) | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM | Bayer Corp. | Jul 22, 1999 | SESE | | [K980013](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K980013.md) | AMYLASE | Ac Biochemicals, Inc. | Feb 4, 1998 | SESE | | [K953211](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K953211.md) | AMYLASE (ETHYLIDENE PNGPG7) KIT | Randox Laboratories, Ltd. | Jun 21, 1996 | SESE | | [K951494](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K951494.md) | AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) | Emd Chemicals, Inc. | Dec 11, 1995 | SESE | | [K940735](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K940735.md) | LIQUID AMYLASE (CNPG3) REAGENT SET | Pointe Scientific, Inc., | Aug 1, 1994 | SESE | | [K940010](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K940010.md) | DMA AMYLASE (DEMAND) PROCEDURE | Data Medical Associates, Inc. | Mar 11, 1994 | SESE | | [K931301](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K931301.md) | OLYMPUS AMYLASE REAGENT | Olympus Corp. | Oct 18, 1993 | SESE | | [K931141](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K931141.md) | BIOTROL AMYLASE CNPG3 | Biotrol, USA, Inc. | May 26, 1993 | SESE | | [K882225](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K882225.md) | -AMYLASE EPS | Boehringer Mannheim Corp. | Jan 3, 1989 | SESE | | [K873572](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K873572.md) | IL 35260, IL TEST AMYLASE REAGENT | Instrumentation Laboratory CO | Oct 20, 1987 | SESE | | [K873250](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K873250.md) | ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL | Roche Diagnostic Systems, Inc. | Oct 20, 1987 | SESE | | [K872831](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K872831.md) | BIOTROL ALPHA AMYLASE | Biotrol, USA, Inc. | Sep 4, 1987 | SESE | | [K871943](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K871943.md) | D.A.T. (TM) AMYLASE REAGENT | Behring Diagnostics, Inc. | Jun 3, 1987 | SESE | | [K864356](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K864356.md) | AMYLASE REAGENT | Trace Scientific , Ltd. | Jan 21, 1987 | SESE | | [K863719](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K863719.md) | AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 | Technicon Instruments Corp. | Nov 13, 1986 | SESE | | [K862370](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K862370.md) | DART AMYLASE-D.S. REAGENT SYSTEM | Coulter Electronics, Inc. | Aug 1, 1986 | SESE | | [K861664](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K861664.md) | AMYLASE PROCEDURE | Data Medical Associates, Inc. | Jul 1, 1986 | SESE | | [K860935](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K860935.md) | EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 | Em Diagnostic Systems, Inc. | May 23, 1986 | SESE | | [K853951](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ/K853951.md) | ISOTRAK AMYLASE TEST AMYLASE ISOENZYME | Behring Diagnostics, Inc. | Jan 7, 1986 | SESE | ## Top Applicants - Harleco — 4 clearances - Behring Diagnostics, Inc. — 2 clearances - Biotrol, USA, Inc. — 2 clearances - Coulter Electronics, Inc. — 2 clearances - Data Medical Associates, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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