Catalytic Methods, Amylase
FDA product code JFJ · Class II (moderate risk) · 21 CFR 862.1070 · Clinical Chemistry
99510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Em Diagnostic Systems, Inc. 7
- Abbott Laboratories 6
- Genzyme Corp. 4
- Pointe Scientific, Inc., 4
- Harleco 3
- Data Medical Associates, Inc. 3
- Sclavo, Inc. 3
- Boehringer Mannheim Corp. 3
- Instrumentation Laboratory CO 3
- Diagnostic Chemicals , Ltd. 2
- Beckman Coulter Inc. 2
- Wiener Laboratories Saic 2
- Teco Diagnostics 2
- Sigma Diagnostics, Inc. 2
- Reagents Applications, Inc. 2
- Medical Analysis Systems, Inc. 2
- Wako Chemicals USA, Inc. 2
- Beckman Instruments, Inc. 2
- Roche Diagnostic Systems, Inc. 2
- Abbott Ireland Diagnostics Division 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210633 | Amylase2JFJ · Traditional | Abbott Ireland Diagnostics Division | 05/26/2022SE |
| K191454 | Atellica CH Amylase_2 (AMY_2)JFJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/30/2019SE |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT…JFJ · Traditional | Biosystems S.A. | 05/02/2019SE |
| K130685 | Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and AmyJFJ · Traditional | Hitachi Chemical Diagnostics, Inc. | 08/09/2013SE |
| K122858 | Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…JFJ · Traditional | Elitechgroup | 10/03/2012SE |
| K091846 | Synchron Systems G7 Amylase (AMY7) Reagent with Model(S) A71607JFJ · Traditional | Beckman Coulter, Inc. | 10/16/2009SE |
| K080823 | Easyra Amylase, Bun, Glu-H, Trig, Uric ReagentJFJ · Traditional | Medica Corp. | 11/17/2008SE |
| K070064 | Amylase Eps ReagentJFJ · Traditional | Thermo Fisher Scientific | 05/22/2007SE |
| K062180 | Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CPJFJ · Traditional | Horiba Abx | 10/02/2006SE |
| K051447 | Sentinel Pancreatic AmylaseJFJ · Traditional | Sentinel Ch. Srl | 01/26/2006SE |
| K040920 | Amylase Liquid Reagent, Model A532-200JFJ · Special | Teco Diagnostics | 05/10/2004SE |
| K040534 | Vitalab Amylase ReagentJFJ · Traditional | Clinical Data, Inc. | 03/11/2004SE |
| K023549 | Wiener Lab Amilasa 405 Aa LiquidaJFJ · Traditional | Wiener Laboratories Saic | 12/09/2002SE |
| K020282 | Jas Amylase Liquid ReagentJFJ · Traditional | Jas Diagnostics, Inc. | 02/28/2002SE |
| K013978 | Synchron Systems Pancreatic Amylase (Pam) ReagentJFJ · Traditional | Beckman Coulter, Inc. | 01/15/2002SE |
| K013101 | Wiener Lab. Amilasa 405 Cinetica Aa, Wiener Lab.Amilasa 405 Cinetica Unitest,Wiener…JFJ · Traditional | Wiener Laboratories Saic | 11/16/2001SE |
| K011843 | Genzyme Direct-Amylase Test ReagentJFJ · Traditional | Genzyme Corp. | 08/10/2001SE |
| K011145 | Modification to Reflotron Amylase, Cat. 1200658JFJ · Traditional | Roche Diagnostics Corp. | 06/25/2001SE |
| K001569 | Infinity Amylase Reagent (Procedure No. 580/568)JFJ · Traditional | Sigma Diagnostics, Inc. | 06/26/2000SE |
| K990025 | Careside AmylaseJFJ · Traditional | Careside, Inc. | 02/08/1999SE |
| K984184 | Wako L-Type AmylaseJFJ · Traditional | Wako Chemicals USA, Inc. | 01/13/1999SE |
| K981653 | AmyJFJ · Traditional | Abbott Laboratories | 08/28/1998SE |
| K981216 | AmyJFJ · Traditional | Abbott Laboratories | 06/08/1998SE |
| K974125 | Il Test AmylaseJFJ · Traditional | Instrumentation Laboratory CO | 12/17/1997SE |
| K974053 | Amylase-Sl Assay Catalogue Number 341-10JFJ · Traditional | Diagnostic Chemicals , Ltd. | 12/08/1997SE |
| K972250 | Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsJFJ · Traditional | Roche Diagnostic Systems, Inc. | 08/12/1997SE |
| K971825 | Pancreatic Amylase, Ethylidene BLOCKED-PNPG7 Enzyme Colorimetric TestJFJ · Traditional | Randox Laboratories, Ltd. | 07/24/1997SE |
| K972297 | Amylase-Incorporating Dynamic Stabilization Technology - (DST)JFJ · Traditional | Trace America, Inc. | 07/17/1997SE |
| K951548 | Ace Amylase ReagentJFJ · Traditional | Schiapparelli Biosystems, Inc. | 05/15/1995SE |
| K945243 | Catalogue Number 321-07/15/50JFJ · Traditional | Diagnostic Chemicals , Ltd. | 02/08/1995SE |
| K944229 | Olympus Amylase ReagentJFJ · Traditional | Olympus America, Inc. | 12/09/1994SE |
| K942961 | Amylase QvetJFJ · Traditional | Prisma Systems | 12/09/1994SE |
| K942640 | Dupont Dimension Amylase MethodJFJ · Traditional | Dupont Medical Products | 09/09/1994SE |
| K934293 | Beckman Pancreatic Amylase (Pamy) ReagentJFJ · Traditional | Beckman-Diagnostic Systems Group | 07/06/1994SE |
| K941091 | Synermed Amylase Reagent KitJFJ · Traditional | Synermed, Inc. | 05/03/1994SE |
| K933682 | Direct Amylase (Ec 3.2.1.1) Method for Technicon SystemsJFJ · Traditional | Miles, Inc. | 04/12/1994SE |
| K930678 | AmylaseJFJ · Traditional | Horizon Diagnostics, Inc. | 04/06/1994SE |
| K932888 | Intersect Systems Direct Amylase ReagentJFJ · Traditional | Intersect Systems, Inc. | 01/31/1994SE |
| K931080 | Amylase Reagent Set (Kinetic)JFJ · Traditional | Teco Diagnostics | 11/05/1993SE |
| K933397 | Genzyme A-Amylase Test ReagentJFJ · Traditional | Genzyme Corp. | 10/28/1993SE |
| K931583 | Silyl AmylJFJ · Traditional | Em Diagnostic Systems, Inc. | 08/19/1993SE |
| K931582 | Ethylidene AmylJFJ · Traditional | Em Diagnostic Systems, Inc. | 08/19/1993SE |
| K930475 | Liquid Amylase Reagent SetJFJ · Traditional | Pointe Scientific, Inc., | 07/19/1993SE |
| K923346 | Olympus Amylase ReagentJFJ · Traditional | Olympus Corp. | 10/02/1992SE |
| K923105 | Miles Urine Amylase MethodJFJ · Traditional | Heraeus Kulzer, Inc. | 09/28/1992SE |
| K923677 | Amylase TestJFJ · Traditional | Em Diagnostic Systems, Inc. | 09/09/1992SE |
| K921057 | Amylase ReagentJFJ · Traditional | Genzyme Corp. | 03/27/1992SE |
| K920583 | Abbott Quickstart Amylase, #5AXXJFJ · Traditional | Em Diagnostic Systems, Inc. | 03/02/1992SE |
| K913744 | Il Test(Tm) AmlylaseJFJ · Traditional | Instrumentation Laboratory CO | 02/18/1992SE |
| K915710 | Amylase (Colorimetric) Reagent SetJFJ · Traditional | Tech Intl. Co. | 01/30/1992SE |
| K913858 | Amylase Reagent (Procedure 577)JFJ · Traditional | Sigma Diagnostics, Inc. | 09/11/1991SE |
| K912519 | Amylase ReagentJFJ · Traditional | Genzyme Corp. | 07/01/1991SE |
| K910158 | AmylaseJFJ · Traditional | Pointe Scientific, Inc., | 04/30/1991SE |
| K905651 | Kinetic Amylase DeterminationJFJ · Traditional | Biochemical Trade, Inc. | 01/31/1991SE |
| K903309 | Roche Cobas Ready Amylase ReagentJFJ · Traditional | Roche Diagnostic Systems, Inc. | 09/07/1990SE |
| K903332 | Systemate Amylase (Amyl) Item Number 65404JFJ · Traditional | Em Diagnostic Systems, Inc. | 08/17/1990SE |
| K902326 | Amylase for Manual/Automated ApplicationsJFJ · Traditional | Catachem, Inc. | 07/31/1990SE |
| K901017 | Du Pont Analyst Analytical Test ROTOR:CHEM-14,CALIJFJ · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 05/15/1990SE |
| K900230 | Coulter Amylase ReagentJFJ · Traditional | Coulter Corp. | 04/03/1990SE |
| K896650 | Amylase ReagentJFJ · Traditional | Sigma Chemical Co. | 02/08/1990SE |
| K893751 | Amylase Test (Aml) Item Number: 65404JFJ · Traditional | Em Diagnostic Systems, Inc. | 08/17/1989SE |
| K891241 | Abbott Spectrum Amylase ReagentJFJ · Traditional | Abbott Laboratories | 08/15/1989SE |
| K892848 | Pancreatic A-Amylase PNPJFJ · Traditional | Boehringer Mannheim Corp. | 07/20/1989SE |
| K885176 | Amylase SR Liquid Stable Reagent SetJFJ · Traditional | Medical Analysis Systems, Inc. | 02/17/1989SE |
| K880867 | Amylase 405 Catalog Number 301-34JFJ · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 04/19/1988SE |
| K874704 | Reflotron (R) AmylaseJFJ · Traditional | Boehringer Mannheim Corp. | 01/05/1988SE |
| K873944 | A-Gent Liquid AmylaseJFJ · Traditional | Abbott Laboratories | 11/23/1987SE |
| K873133 | Bnp-Amylase TestJFJ · Traditional | Sclavo, Inc. | 10/06/1987SE |
| K872023 | Amylase Test KitJFJ · Traditional | Ciba Corning Diagnostics Corp. | 08/05/1987SE |
| K870746 | Stanbio Alpha-Amylase Test Set, Catalog 0180-715JFJ · Traditional | Stanbio Laboratory | 06/01/1987SE |
| K871269 | Ra System, Analyte Serum Amylase (30C and 37C)JFJ · Traditional | Technicon Instruments Corp. | 04/13/1987SE |
| K864825 | Amylase Colorimetric ProcedureJFJ · Traditional | Data Medical Associates, Inc. | 02/20/1987SE |
| K864464 | Psi Amylase ReagentJFJ · Traditional | Pointe Scientific, Inc., | 01/21/1987SE |
| K864303 | Qko (TM) Amylase B-HaJFJ · Traditional | Wako Chemicals USA, Inc. | 12/31/1986SE |
| K864435 | Vision(Tm) AmylaseJFJ · Traditional | Abbott Laboratories | 12/16/1986SE |
| K863622 | Tdx(R) Amylase IIJFJ · Traditional | Abbott Laboratories | 10/03/1986SE |
| K863588 | Amylase ProcedureJFJ · Traditional | Data Medical Associates, Inc. | 09/29/1986SE |
| K862733 | Amylase SR Liquid Stable Reagent SetJFJ · Traditional | Medical Analysis Systems, Inc. | 09/29/1986SE |
| K861718 | Amylase Reagent Catalogue Nos. 85108 and 85109JFJ · Traditional | Reagents Applications, Inc. | 05/29/1986SE |
| K861269 | Raichem Amylase ReagentJFJ · Traditional | Reagents Applications, Inc. | 05/29/1986SE |
| K860665 | Alpha-Amylase TestJFJ · Traditional | Sclavo, Inc. | 04/07/1986SE |
| K860918 | Easy-Test Amlase (Amyl), #67521/93JFJ · Traditional | Em Diagnostic Systems, Inc. | 04/03/1986SE |
| K860245 | Enzymatic Alpha-Amylase Reagent KitJFJ · Traditional | Bio-Analytics Laboratories, Inc. | 03/14/1986SE |
| K852001 | Amy ReagentJFJ · Traditional | Alpkem Corp. | 06/10/1985SE |
| K850798 | Amylase ProductsJFJ · Traditional | Data Medical Associates, Inc. | 03/14/1985SE |
| K832889 | AmylaseJFJ · Traditional | Pointe Scientific, Inc., | 11/25/1983SE |
| K831561 | Amylast-D TestJFJ · Traditional | Sclavo, Inc. | 07/07/1983SE |
| K831536 | Paramax Amaline ReagentJFJ · Traditional | American Dade | 06/17/1983SE |
| K823462 | Single Vial Amylase PNP TestJFJ · Traditional | Boehringer Mannheim Corp. | 12/28/1982SE |
| K821869 | Ultrazyme Plus AmylJFJ · Traditional | Harleco Diagnostics | 07/13/1982SE |
| K821459 | Ultrazyme Plus Amyl #65031&64982JFJ · Traditional | Emd Chemicals, Inc. | 05/28/1982SE |
| K802581 | Bekcman Astra Systems Amylase ChemistryJFJ · Traditional | Beckman Instruments, Inc. | 11/12/1980SE |
| K801295 | Cobas Reagent for A-AmylaseJFJ · Traditional | Roche Analytical Instruments, Inc. | 07/08/1980SE |
| K800049 | Delta Test Amylase UVJFJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/23/1980SE |
| K772035 | Gemsaec Appli. for Ultrazyme Plus Y-AmylJFJ · Traditional | Harleco | 11/17/1977SE |
| K771622 | Multistat III, Amylase TestJFJ · Traditional | Instrumentation Laboratory CO | 09/13/1977SE |
| K771388 | Amylase Ultrazyme PlusJFJ · Traditional | Harleco | 09/02/1977SE |
| K771131 | Clinicard UV Amylase ChemistryJFJ · Traditional | Harleco | 07/21/1977SE |
| K770750 | Reagent Kit, Enzymatic AmylaseJFJ · Traditional | Beckman Instruments, Inc. | 07/05/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2924-2020 Class II | Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 ReagentAmylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted… | Randox Laboratories, Ltd. | 07/10/2020Terminated |
| Z-0688-2008 | Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics…False Results- The reagent of the LDL-Cholesterol assay shows a carryover effect on the Lipase assay.… | Roche Diagnostics Corp. | 12/03/2007Terminated |