Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JFJ — Predicate Candidate Screening
99 FDA 510(k) clearances under this product code; the 50 most recent screened below.
57 daysmedian FDA review time
182 days90th percentile
99clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210633 | Amylase2 | Abbott Ireland Diagnostics Division | 2022-05-26 | 449 | 0 |
| K191454 | Atellica CH Amylase_2 (AMY_2) | Siemens Healthcare Diagnostics, Inc. | 2019-07-30 | 60 | 0 |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCR | Biosystems S.A. | 2019-05-02 | 234 | 0 |
| K130685 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD A | Hitachi Chemical Diagnostics, Inc. | 2013-08-09 | 149 | 0 |
| K122858 | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS E | Elitechgroup | 2012-10-03 | 15 | 0 |
| K091846 | SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71 | Beckman Coulter, Inc. | 2009-10-16 | 116 | 0 |
| K080823 | EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT | Medica Corp. | 2008-11-17 | 238 | 0 |
| K070064 | AMYLASE EPS REAGENT | Thermo Fisher Scientific | 2007-05-22 | 137 | 0 |
| K062180 | ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN | Horiba Abx | 2006-10-02 | 63 | 0 |
| K051447 | SENTINEL PANCREATIC AMYLASE | Sentinel Ch. Srl | 2006-01-26 | 238 | 0 |
| K040920 | AMYLASE LIQUID REAGENT, MODEL A532-200 | Teco Diagnostics | 2004-05-10 | 32 | 0 |
| K040534 | VITALAB AMYLASE REAGENT | Clinical Data, Inc. | 2004-03-11 | 9 | 0 |
| K023549 | WIENER LAB AMILASA 405 AA LIQUIDA | Wiener Laboratories Saic | 2002-12-09 | 48 | 0 |
| K020282 | JAS AMYLASE LIQUID REAGENT | Jas Diagnostics, Inc. | 2002-02-28 | 31 | 0 |
| K013978 | SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT | Beckman Coulter, Inc. | 2002-01-15 | 43 | 0 |
| K013101 | WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 | Wiener Laboratories Saic | 2001-11-16 | 60 | 0 |
| K011843 | GENZYME DIRECT-AMYLASE TEST REAGENT | Genzyme Corp. | 2001-08-10 | 59 | 0 |
| K011145 | MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 | Roche Diagnostics Corp. | 2001-06-25 | 91 | 0 |
| K001569 | INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) | Sigma Diagnostics, Inc. | 2000-06-26 | 38 | 0 |
| K990025 | CARESIDE AMYLASE | Careside, Inc. | 1999-02-08 | 35 | 0 |
| K984184 | WAKO L-TYPE AMYLASE | Wako Chemicals USA, Inc. | 1999-01-13 | 51 | 0 |
| K981653 | AMY | Abbott Laboratories | 1998-08-28 | 109 | 0 |
| K981216 | AMY | Abbott Laboratories | 1998-06-08 | 66 | 0 |
| K974125 | IL TEST AMYLASE | Instrumentation Laboratory CO | 1997-12-17 | 44 | 0 |
| K974053 | AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 | Diagnostic Chemicals , Ltd. | 1997-12-08 | 42 | 0 |
| K972250 | ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | Roche Diagnostic Systems, Inc. | 1997-08-12 | 57 | 1 |
| K971825 | PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIME | Randox Laboratories, Ltd. | 1997-07-24 | 69 | 0 |
| K972297 | AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DS | Trace America, Inc. | 1997-07-17 | 28 | 0 |
| K951548 | ACE AMYLASE REAGENT | Schiapparelli Biosystems, Inc. | 1995-05-15 | 41 | 0 |
| K945243 | CATALOGUE NUMBER 321-07/15/50 | Diagnostic Chemicals , Ltd. | 1995-02-08 | 104 | 0 |
| K942961 | AMYLASE QVET | Prisma Systems | 1994-12-09 | 169 | 0 |
| K944229 | OLYMPUS AMYLASE REAGENT | Olympus America, Inc. | 1994-12-09 | 100 | 0 |
| K942640 | DUPONT DIMENSION AMYLASE METHOD | Dupont Medical Products | 1994-09-09 | 98 | 0 |
| K934293 | BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT | Beckman-Diagnostic Systems Group | 1994-07-06 | 307 | 0 |
| K941091 | SYNERMED AMYLASE REAGENT KIT | Synermed, Inc. | 1994-05-03 | 56 | 0 |
| K933682 | DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS | Miles, Inc. | 1994-04-12 | 257 | 0 |
| K930678 | AMYLASE | Horizon Diagnostics, Inc. | 1994-04-06 | 421 | 0 |
| K932888 | INTERSECT SYSTEMS DIRECT AMYLASE REAGENT | Intersect Systems, Inc. | 1994-01-31 | 231 | 0 |
| K931080 | AMYLASE REAGENT SET (KINETIC) | Teco Diagnostics | 1993-11-05 | 248 | 0 |
| K933397 | GENZYME A-AMYLASE TEST REAGENT | Genzyme Corp. | 1993-10-28 | 108 | 0 |
| K931583 | SILYL AMYL | Em Diagnostic Systems, Inc. | 1993-08-19 | 141 | 0 |
| K931582 | ETHYLIDENE AMYL | Em Diagnostic Systems, Inc. | 1993-08-19 | 141 | 0 |
| K930475 | LIQUID AMYLASE REAGENT SET | Pointe Scientific, Inc., | 1993-07-19 | 172 | 0 |
| K923346 | OLYMPUS AMYLASE REAGENT | Olympus Corp. | 1992-10-02 | 94 | 0 |
| K923105 | MILES URINE AMYLASE METHOD | Heraeus Kulzer, Inc. | 1992-09-28 | 101 | 0 |
| K923677 | AMYLASE TEST | Em Diagnostic Systems, Inc. | 1992-09-09 | 49 | 0 |
| K921057 | AMYLASE REAGENT | Genzyme Corp. | 1992-03-27 | 22 | 0 |
| K920583 | ABBOTT QUICKSTART AMYLASE, #5AXX | Em Diagnostic Systems, Inc. | 1992-03-02 | 21 | 0 |
| K913744 | IL TEST(TM) AMLYLASE | Instrumentation Laboratory CO | 1992-02-18 | 182 | 0 |
| K915710 | AMYLASE (COLORIMETRIC) REAGENT SET | Tech Intl. Co. | 1992-01-30 | 62 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda