Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PCH — Predicate Candidate Screening
38 FDA 510(k) clearances under this product code; the 50 most recent screened below.
109 daysmedian FDA review time
265 days90th percentile
38clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex Assay | Luminex Corporation | 2026-05-19 | 176 | 0 |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 M | QIAGEN GmbH | 2026-03-09 | 83 | 0 |
| K251721 | Xpert GI Panel | Cepheid | 2026-01-16 | 226 | 0 |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 M | QIAGEN GmbH | 2025-10-22 | 89 | 0 |
| K251868 | Panther Fusion GI Bacterial Assay | Hologic | 2025-09-25 | 99 | 0 |
| K251993 | Panther Fusion GI Expanded Bacterial Assay | Hologic, Inc. | 2025-09-25 | 90 | 0 |
| K250324 | QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | 2025-02-28 | 23 | 0 |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | Biofire Diagnostics, LLC | 2025-01-16 | 29 | 0 |
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2025-01-10 | 109 | 0 |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&V | QIAGEN GmbH | 2025-01-08 | 28 | 0 |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2024-11-07 | 90 | 0 |
| K220062 | QIAstat-Dx Gastrointestinal Panel 2 | QIAGEN GmbH | 2024-05-31 | 872 | 0 |
| K232672 | EasyScreen Gastrointestinal Parasite Detection Kit | Genetic Signatures Limited | 2024-05-29 | 271 | 0 |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2023-03-16 | 29 | 3 |
| K220607 | BD MAX Enteric Viral Panel | Becton, Dickinson and Company | 2022-09-21 | 203 | 0 |
| K220193 | BD MAX Enteric Parasite Panel | Becton, Dickinson and Company | 2022-08-19 | 207 | 0 |
| K191161 | xTAG Gastrointestinal Pathogen Panel (GPP) | Luminex Molecular Diagnostics, Inc. | 2019-11-12 | 195 | 0 |
| K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analys | Luminex Molecular Diagnostics, Inc. | 2019-11-04 | 187 | 0 |
| K182703 | EntericBio Dx Assay | Serosep , Ltd. | 2019-06-19 | 265 | 0 |
| K190585 | Biocode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2019-06-05 | 91 | 0 |
| K183023 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analys | Luminex Molecular Diagnostics, Inc. | 2018-11-30 | 29 | 0 |
| K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analys | Luminex Molecular Diagnostics, Inc. | 2018-11-30 | 29 | 0 |
| K181427 | BD MAX Enteric Viral Panel, BD MAX Instrument | Becton, Dickinson and Company | 2018-11-29 | 181 | 0 |
| K180041 | BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2018-09-28 | 266 | 0 |
| K170308 | BD MAX Extended Enteric Bacterial Panel, BD MAX System | Becton, Dickinson and Company | 2017-05-02 | 90 | 0 |
| K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray | Biofire Diagnostics, LLC | 2016-04-01 | 42 | 5 |
| K152955 | Great Basin Shiga Toxin Direct Test | Great Basin Scientific, Inc. | 2016-03-22 | 167 | 0 |
| K143648 | BD MAX Enteric Parasite Panel, BD MAX Instrument | Becton, Dickinson and Company | 2015-08-25 | 246 | 0 |
| K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmA | Biofire Diagnostics, LLC | 2015-02-19 | 122 | 6 |
| K142501 | Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, G | Cepheid | 2014-11-26 | 82 | 0 |
| K140647 | XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS | Luminex Molecular Diagnostics, Inc. | 2014-10-24 | 225 | 0 |
| K142033 | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) | Nanospere,Inc. | 2014-10-10 | 77 | 0 |
| K140377 | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSI | Luminex Molecular Diagnostics, Inc. | 2014-09-16 | 214 | 0 |
| K140083 | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) | Nanosphere, Inc. | 2014-06-20 | 158 | 2 |
| K140407 | FILMARRAY GASTROINTESTINAL (GI) PANEL | Biofire Diagnostics | 2014-05-02 | 73 | 6 |
| K121894 | XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS | Luminex Molecular Diagnostics, Inc. | 2013-03-21 | 265 | 0 |
| K123274 | PROGASTRO SSCS ASSAY | Gen-Probe Prodesse, Inc. | 2013-01-16 | 89 | 0 |
| DEN130003 | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSI | Luminex Molecular Diagnostics, Inc. | 2013-01-14 | 3 | 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