JFJ · Catalytic Methods, Amylase
Clinical Chemistry · 21 CFR 862.1070 · Class 2
Overview
| Product Code | JFJ |
|---|---|
| Device Name | Catalytic Methods, Amylase |
| Regulation | 21 CFR 862.1070 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 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 | Amylase2 | Abbott Ireland Diagnostics Division | May 26, 2022 | SESE |
| K191454 | Atellica CH Amylase_2 (AMY_2) | Siemens Healthcare Diagnostics, Inc. | Jul 30, 2019 | SESE |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL | Biosystems S.A. | May 2, 2019 | SESE |
| K130685 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY | Hitachi Chemical Diagnostics, Inc. | Aug 9, 2013 | SESE |
| K122858 | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II | Elitechgroup | Oct 3, 2012 | SESE |
| K091846 | SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 | Beckman Coulter, Inc. | Oct 16, 2009 | SESE |
| K080823 | EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT | Medica Corp. | Nov 17, 2008 | SESE |
| K070064 | AMYLASE EPS REAGENT | Thermo Fisher Scientific | May 22, 2007 | SESE |
| K062180 | ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP | Horiba Abx | Oct 2, 2006 | SESE |
| K051447 | SENTINEL PANCREATIC AMYLASE | Sentinel Ch. Srl | Jan 26, 2006 | SESE |
| K040920 | AMYLASE LIQUID REAGENT, MODEL A532-200 | Teco Diagnostics | May 10, 2004 | SESE |
| K040534 | VITALAB AMYLASE REAGENT | Clinical Data, Inc. | Mar 11, 2004 | SESE |
| K023549 | WIENER LAB AMILASA 405 AA LIQUIDA | Wiener Laboratories Saic | Dec 9, 2002 | SESE |
| K020282 | JAS AMYLASE LIQUID REAGENT | Jas Diagnostics, Inc. | Feb 28, 2002 | SESE |
| K013978 | SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT | Beckman Coulter, Inc. | Jan 15, 2002 | SESE |
| K013101 | 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 | GENZYME DIRECT-AMYLASE TEST REAGENT | Genzyme Corp. | Aug 10, 2001 | SESE |
| K011145 | MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 | Roche Diagnostics Corp. | Jun 25, 2001 | SESE |
| K001569 | INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) | Sigma Diagnostics, Inc. | Jun 26, 2000 | SESE |
| K990025 | 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
