Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LYR — Predicate Candidate Screening
91 FDA 510(k) clearances under this product code; the 50 most recent screened below.
137 daysmedian FDA review time
308 days90th percentile
91clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232892 | Hp Detect™ Stool Antigen ELISA | Biomerica, Inc. | 2023-12-15 | 88 | 0 |
| K230901 | Premier HpSA Flex (619096) | Meridian Bioscience, Inc. | 2023-07-03 | 94 | 0 |
| K192817 | Curian HpSA, Curian Analyzer | Meridian Bioscience, Inc. | 2020-03-13 | 164 | 0 |
| K183573 | Vstrip H. pylori Antigen Rapid Test | Panion & BF Biotech, Inc. | 2019-03-14 | 83 | 0 |
| K182559 | PREMIER Platinum HpSA PLUS | Meridian Bioscience, Inc. | 2018-11-05 | 49 | 0 |
| K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen C | DiaSorin, Inc. | 2018-08-31 | 88 | 0 |
| K181379 | H. PYLORI QUIK CHEK | Techlab, Inc. | 2018-08-21 | 89 | 0 |
| K181400 | H. PYLORI CHEK™ | Techlab, Inc. | 2018-08-21 | 84 | 0 |
| K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set | DiaSorin, Inc. | 2016-07-22 | 91 | 0 |
| K153661 | ImmunoCard STAT! HpSA | Meridian Bioscience, Inc. | 2016-03-14 | 84 | 0 |
| K151935 | Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Si | Alere San Diego, Incorporated | 2015-08-12 | 29 | 0 |
| K141133 | VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB I | BIOMERIEUX | 2015-07-09 | 434 | 2 |
| K110745 | HELICOBACTER PYLORI ELISA IGG TEST KIT | Gold Standard Diagnostics | 2012-03-02 | 351 | 0 |
| K110899 | GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT | Gold Standard Diagnostics | 2012-02-01 | 308 | 0 |
| K052716 | RAPIRUN H. PYLORI ANTIBODY DETECTION KIT | Otsuka Pharmaceutical Co., Ltd. | 2006-11-16 | 413 | 0 |
| K052708 | PYLO-PLUS | Arj Medical, Inc. | 2006-05-01 | 214 | 0 |
| K053335 | PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 | Meridian Bioscience, Inc. | 2006-03-10 | 99 | 0 |
| K041238 | HELICOBACTER PYLORI IGG ELISA | Biohit Plc | 2004-12-13 | 216 | 0 |
| K032222 | IMMUNOCARDSTAT HPSA | Meridian Bioscience, Inc. | 2003-12-05 | 137 | 0 |
| K033067 | PYLORI IGG | Trinity Biotech USA | 2003-11-26 | 58 | 0 |
| K024360 | INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST | Alfa Scientific Designs, Inc. | 2003-06-10 | 162 | 0 |
| K024350 | ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TES | ACON Laboratories, Inc. | 2003-04-02 | 93 | 0 |
| K024334 | QUANTA LITE H.PYLORI IGA ELISA | Inova Diagnostics, Inc. | 2003-03-27 | 91 | 0 |
| K022356 | NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG | Nichols Institute Diagnostics | 2002-10-25 | 98 | 0 |
| K014038 | PYLORITEK VP TEST KIT 5140VP | Serim Research Corp. | 2002-02-08 | 63 | 0 |
| K012588 | OXOID PYLORI TEST KIT, MODEL DR0130M | Oxoid , Ltd. | 2001-12-10 | 122 | 0 |
| K012411 | HP-ONE | Gi Supply | 2001-09-25 | 57 | 0 |
| K003794 | ELISA TEST, SEROLOGY | Micro Detect, Inc. | 2001-03-30 | 112 | 0 |
| K002023 | MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 | Medmira Laboratories, Inc. | 2000-11-13 | 133 | 0 |
| K001177 | PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI | Enteric Products, Inc. | 2000-11-13 | 216 | 0 |
| K001460 | VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 | bioMerieux, Inc. | 2000-10-04 | 147 | 0 |
| K002451 | MODIFICATION TO: PRONTO DRY | Medical Instruments Corporation, AG | 2000-09-29 | 51 | 0 |
| K000463 | IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG | Diagnostic Products Corp. | 2000-06-01 | 111 | 1 |
| K991697 | UNI-GOLD H. PYLORI | Trinity Biotech, Plc | 1999-12-21 | 217 | 0 |
| K990462 | IS H. PYLORI IGG ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1999-09-03 | 203 | 0 |
| K991820 | HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED | Zeus Scientific, Inc. | 1999-08-12 | 77 | 0 |
| K991747 | QUICKVUE ONE-STEP H. PYLORI II TEST | Quidel Corp. | 1999-08-04 | 75 | 0 |
| K991248 | PRONTO DRY | Medical Instruments Corporation Mic AG | 1999-06-22 | 71 | 0 |
| K984544 | THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN | Enteric Products, Inc. | 1999-02-18 | 58 | 0 |
| K983255 | MODIFICATION TO: PREMIER PLATINUM HPSA | Meridian Diagnostics, Inc. | 1998-12-17 | 93 | 1 |
| K982362 | ABBOTT TESTPACK PLUS H. PYLORI | Abbott Laboratories | 1998-11-18 | 135 | 0 |
| K982790 | QUANTA LITE H. PYLORI IGG ELISA | Inova Diagnostics, Inc. | 1998-11-04 | 86 | 0 |
| K980798 | BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TE | Princeton BioMeditech Corp. | 1998-09-22 | 204 | 1 |
| K980782 | STAT-SIMPLE PYLORI | Saliva Diagnostic Systems, Inc. | 1998-08-05 | 156 | 0 |
| K981396 | PYLORIPROBE | Amdl, Inc. | 1998-07-30 | 104 | 0 |
| K980821 | HELICOBACTER PYLORI IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1998-07-30 | 149 | 0 |
| K980076 | PREMIER PLATINUM HPSA | Meridian Diagnostics, Inc. | 1998-05-12 | 124 | 0 |
| K972981 | SHIELD HELICO-G2 ELISA KIT | Shield Diagnostics, Ltd. | 1998-03-17 | 218 | 0 |
| K973508 | PYLORI DETECT IGG | Micro Detect, Inc. | 1998-03-10 | 175 | 0 |
| K973523 | ACCUSTAT H. PYLORI ONE STEP TEST | Boehringer Mannheim Corp. | 1998-03-03 | 167 | 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