Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Microbiology — Predicate Candidate Screening
6,936 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
90 daysmedian FDA review time
273 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253453 | Metrix COVID Test; Metrix COVID Test Pro | Aptitude Medical Systems, Inc. | 2026-08-07 | 305 | 0 |
| K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | QIAGEN GmbH | 2026-08-06 | 226 | 0 |
| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) | Thermo Fisher Scientific (Oxoid Ltd.) | 2026-07-24 | 56 | 0 |
| K261853 | Gepotidacin GEP 10 µg | Liofilchem, Inc. | 2026-07-23 | 50 | 0 |
| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | Biofire Defense, LLC | 2026-07-17 | 73 | 0 |
| K260021 | cobas® BV/CV | Roche Molecular Systems, Inc. | 2026-07-16 | 192 | 0 |
| K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | ACON Laboratories, Inc. | 2026-07-10 | 87 | 0 |
| K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 2026-07-10 | 191 | 0 |
| K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cob | Roche Molecular Systems, Inc. | 2026-07-08 | 111 | 0 |
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | bioMerieux, Inc. | 2026-07-08 | 169 | 0 |
| K261867 | Xpert Carba-R | Cepheid® | 2026-07-02 | 28 | 0 |
| K253316 | PhAST instrument and PhAST Blood Culture Gram-negative Panel | Phast Corp. | 2026-06-26 | 269 | 0 |
| K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control | Diasorin Molecular, LLC | 2026-06-15 | 133 | 0 |
| K252932 | Fast PCR Mini Respiratory Panel | Autonomous Medical Devices Incorporated | 2026-06-12 | 270 | 0 |
| K254121 | Colli-Pee•Dx Urine Collection Kit | DNA Genotek, Inc. | 2026-06-10 | 173 | 0 |
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antig | Assure Tech., LLC | 2026-06-05 | 88 | 0 |
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | DiaSorin, Inc. | 2026-06-04 | 87 | 0 |
| K253882 | CorDx Tyfast COVID-19 Ag Rapid Test Rx | CorDx, Inc. | 2026-06-01 | 179 | 0 |
| K260213 | BD BACTEC FXI Culture System | BD Diagnostic Systems | 2026-05-28 | 125 | 0 |
| K253971 | Visby Medical Flu and COVID-19 Test | Visby Medical, Inc. | 2026-05-27 | 167 | 0 |
| K253722 | LIAISON PLEX Gastrointestinal Flex Assay | Luminex Corporation | 2026-05-19 | 176 | 0 |
| K260577 | FilmArray TF Control Panel M527 | Maine Molecular Quality Controls, Inc. | 2026-05-19 | 88 | 0 |
| K253759 | cobas liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | 2026-05-15 | 171 | 0 |
| K253756 | cobas liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | 2026-05-15 | 171 | 0 |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | 2026-05-11 | 56 | 0 |
| K254139 | BioCode® Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | 2026-05-01 | 130 | 0 |
| K260342 | AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-30 | 87 | 0 |
| K252424 | Anti-HCV Next | Abbott Laboratories | 2026-04-28 | 270 | 0 |
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL) | bioMérieux SA | 2026-04-21 | 69 | 0 |
| K260696 | MTS Gepotidacin 0.016-256 µg/mL | Liofilchem s.r.l. | 2026-04-17 | 45 | 0 |
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | 2026-04-15 | 76 | 0 |
| K253573 | ASTar BC G- Kit | Q-Linea AB | 2026-04-15 | 149 | 0 |
| K252280 | Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics | 2026-04-13 | 265 | 0 |
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | Healgen Scientific,, LLC | 2026-04-13 | 90 | 0 |
| K260049 | Elecsys Anti-HBc IgM | Roche Diagnostics | 2026-04-07 | 90 | 0 |
| K260046 | Elecsys Anti-HBc II | Roche Diagnostics | 2026-04-07 | 90 | 0 |
| K260048 | Elecsys Anti-HAV IgM | Roche Diagnostics | 2026-04-07 | 90 | 0 |
| K260184 | Onclarity™ Self-Collection Kit | Becton, Dickinson and Company | 2026-04-02 | 71 | 0 |
| K252269 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies, Inc. | 2026-03-30 | 252 | 0 |
| K260041 | MDx-Chex for BCP | Streck, LLC | 2026-03-27 | 80 | 0 |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | BIOMERIEUX | 2026-03-26 | 56 | 0 |
| K260787 | FebriDx Bacterial/Non-bacterial Assay | Lumos Diagnostics, Inc. | 2026-03-24 | 14 | 0 |
| K254166 | MDx-Chex for BCN | Streck | 2026-03-23 | 90 | 0 |
| K254167 | MDx-Chex for BCY | Streck, LLC | 2026-03-17 | 84 | 0 |
| K251916 | GenBody COVID-19 Ag Home Test | Genbody.Inc. | 2026-03-13 | 263 | 0 |
| K254059 | Access anti-HBc IgM | Beckman Coulter, Inc. | 2026-03-13 | 86 | 0 |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 M | QIAGEN GmbH | 2026-03-09 | 83 | 0 |
| K253687 | Access anti-HBc Total | Beckman Coulter, Inc. | 2026-02-19 | 90 | 0 |
| K251742 | VELO Respiratory Test | Lex Diagnostics Limited | 2026-02-13 | 252 | 0 |
| K253318 | Clungene RSV Antigen Rapid Test | Hangzhou Clongene Biotech Co., Ltd. | 2026-01-30 | 122 | 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