Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OCC — Predicate Candidate Screening
79 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
210 days90th percentile
79clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254139 | BioCode® Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | 2026-05-01 | 130 | 0 |
| K242613 | NxTAG® Respiratory Pathogen Panel | Luminex Molecular Diagnostics, Inc. | 2024-10-02 | 29 | 0 |
| K232775 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2023-10-10 | 29 | 2 |
| K231017 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | 2023-05-05 | 25 | 0 |
| K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the c | Roche Molecular Systems, Inc. | 2022-07-06 | 210 | 0 |
| K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the c | Roche Molecular Systems, Inc. | 2021-02-16 | 19 | 0 |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV | Diasorin Molecular, LLC | 2020-08-22 | 78 | 1 |
| K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas L | Roche Molecular Systems, Inc. | 2020-02-10 | 28 | 0 |
| K192485 | BioCode Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | 2019-12-23 | 104 | 0 |
| K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen | Luminex Molecular Diagnostics, Inc. | 2019-12-11 | 26 | 1 |
| K191729 | Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas L | Roche Molecular Systems, Inc. | 2019-07-24 | 27 | 0 |
| K191534 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2019-07-11 | 31 | 0 |
| K183597 | QIAstat-Dx Respiratory Panel | QIAGEN GmbH | 2019-05-18 | 148 | 0 |
| K181443 | Accula RSV Test | Mesa Biotech, Inc. | 2018-11-23 | 176 | 0 |
| K181289 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit | Cepheid | 2018-08-15 | 91 | 0 |
| K180218 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection | Cepheid | 2018-07-24 | 180 | 0 |
| K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere | Alere Scarborough, Inc. | 2018-01-26 | 31 | 0 |
| K171552 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit | Cepheid | 2017-12-19 | 207 | 0 |
| K172629 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | 2017-12-04 | 94 | 0 |
| K171974 | Solana RSV+hMPV Assay | Quidel Corporation | 2017-10-16 | 108 | 0 |
| K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influ | Alere Scarborough, Inc. | 2017-09-29 | 105 | 1 |
| K171963 | Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal F | Hologic, Inc. | 2017-09-26 | 88 | 0 |
| K163628 | Idylla Respiratory (IFV-RSV) Panel | Janssen Pharmaceutica NV | 2017-08-30 | 251 | 0 |
| K163636 | ePlex Respiratory Pathogen Panel | Genmark Diagnostics, Incorporated | 2017-06-09 | 169 | 0 |
| K170604 | FilmArray Respiratory Panel 2 (RP2) | Biofire Diagnostics, LLC | 2017-05-30 | 90 | 0 |
| K162456 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit | Cepheid | 2017-02-13 | 164 | 0 |
| K162331 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection | Cepheid | 2017-02-09 | 174 | 0 |
| K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swa | Alere Scarborough, Inc. | 2016-12-21 | 30 | 0 |
| K152579 | FilmArray Respiratory Panel EZ (RP EZ) | Biofire Diagnostics, LLC | 2016-10-03 | 389 | 0 |
| K161814 | Solana Influenza A+B Assay | Quidel Corporation | 2016-09-27 | 88 | 0 |
| K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Ki | Alere Scarborough, Inc. | 2016-08-18 | 92 | 2 |
| K161220 | ARIES® Flu A/B & RSV Assay | Luminex Corporation | 2016-08-02 | 95 | 1 |
| K153544 | cobas Influenza A/B & RSV Nucleic Acid Test for Use on the c | Iquum, Inc. | 2016-07-25 | 227 | 0 |
| K160068 | FilmArray Respiratory Panel (RP) for use with FilmArray Torc | Biofire Diagnostics, LLC | 2016-02-08 | 26 | 1 |
| K152386 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen | Luminex Molecular Diagnostics, Inc. | 2015-12-17 | 115 | 1 |
| K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection | Cepheid | 2015-12-03 | 210 | 0 |
| K153219 | ProFlu+ Assay | Hologic, Inc. | 2015-11-20 | 15 | 0 |
| K152523 | JBAIDS Influenza A & B Detection Kit | U.S Army Medical Materiel Development Activity | 2015-10-01 | 28 | 0 |
| K152408 | Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Pos | Focus Diagnostics, Inc. | 2015-09-21 | 27 | 1 |
| K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Fl | Nanosphere, Inc. | 2015-09-04 | 255 | 1 |
| K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influen | Alere Scarborough, Inc. | 2015-07-28 | 57 | 0 |
| K143080 | FilmArray Respiratory Panel (RP) for use with Multi-instrume | Biofire Diagnostics, LLC | 2015-02-17 | 113 | 0 |
| K142365 | Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positiv | Focus Diagnostics | 2014-12-05 | 102 | 0 |
| K142045 | XPERT FLU/RSV XC ASSAY | Cepheid | 2014-11-22 | 117 | 0 |
| K141931 | LYRA ADENOVIRUS ASSAY | Quidel Corporation | 2014-10-09 | 85 | 0 |
| K141520 | ALERE I INFLUENZA A & B | Alere Scarborough, Inc D/B/A Binax, Inc. | 2014-06-13 | 4 | 3 |
| K131813 | QUIDEL MOLECULAR RSV + HMPV ASSAY | Quidel Corp. | 2013-09-06 | 78 | 0 |
| K131584 | IMDX FLU A/B AND RSV FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | 2013-08-21 | 82 | 0 |
| K132159 | PROADENO+ ASSAY | Gen-Probe Prodesse, Inc. | 2013-08-14 | 33 | 0 |
| K132129 | PRODESSE PROFLU+ ASSAY | Gen-Probe Prodesse, Inc. | 2013-08-09 | 30 | 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