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) → JFJ — Catalytic Methods, Amylase # JFJ · Catalytic Methods, 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/JFJ ## Overview - **Product Code:** JFJ - **Device Name:** Catalytic Methods, 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 99) Showing 20 most recent of 99 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K210633](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K210633.md) | Amylase2 | Abbott Ireland Diagnostics Division | May 26, 2022 | SESE | | [K191454](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K191454.md) | Atellica CH Amylase_2 (AMY_2) | Siemens Healthcare Diagnostics, Inc. | Jul 30, 2019 | SESE | | [K182474](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K182474.md) | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL | Biosystems S.A. | May 2, 2019 | SESE | | [K130685](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K130685.md) | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY | Hitachi Chemical Diagnostics, Inc. | Aug 9, 2013 | SESE | | [K122858](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K122858.md) | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II | Elitechgroup | Oct 3, 2012 | SESE | | [K091846](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K091846.md) | SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 | Beckman Coulter, Inc. | Oct 16, 2009 | SESE | | [K080823](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K080823.md) | EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT | Medica Corp. | Nov 17, 2008 | SESE | | [K070064](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K070064.md) | AMYLASE EPS REAGENT | Thermo Fisher Scientific | May 22, 2007 | SESE | | [K062180](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K062180.md) | ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP | Horiba Abx | Oct 2, 2006 | SESE | | [K051447](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K051447.md) | SENTINEL PANCREATIC AMYLASE | Sentinel Ch. Srl | Jan 26, 2006 | SESE | | [K040920](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K040920.md) | AMYLASE LIQUID REAGENT, MODEL A532-200 | Teco Diagnostics | May 10, 2004 | SESE | | [K040534](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K040534.md) | VITALAB AMYLASE REAGENT | Clinical Data, Inc. | Mar 11, 2004 | SESE | | [K023549](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K023549.md) | WIENER LAB AMILASA 405 AA LIQUIDA | Wiener Laboratories Saic | Dec 9, 2002 | SESE | | [K020282](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K020282.md) | JAS AMYLASE LIQUID REAGENT | Jas Diagnostics, Inc. | Feb 28, 2002 | SESE | | [K013978](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K013978.md) | SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT | Beckman Coulter, Inc. | Jan 15, 2002 | SESE | | [K013101](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K013101.md) | WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA | Wiener Laboratories Saic | Nov 16, 2001 | SESE | | [K011843](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K011843.md) | GENZYME DIRECT-AMYLASE TEST REAGENT | Genzyme Corp. | Aug 10, 2001 | SESE | | [K011145](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K011145.md) | MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 | Roche Diagnostics Corp. | Jun 25, 2001 | SESE | | [K001569](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K001569.md) | INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) | Sigma Diagnostics, Inc. | Jun 26, 2000 | SESE | | [K990025](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ/K990025.md) | CARESIDE AMYLASE | Careside, Inc. | Feb 8, 1999 | SESE | ## Top Applicants - Em Diagnostic Systems, Inc. — 7 clearances - Abbott Laboratories — 6 clearances - Genzyme Corp. — 4 clearances - Pointe Scientific, Inc., — 4 clearances - Boehringer Mannheim Corp. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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