Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PSZ — Predicate Candidate Screening
72 FDA 510(k) clearances under this product code; the 50 most recent screened below.
58 daysmedian FDA review time
273 days90th percentile
72clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252283 | Nano-Check Influenza A+B Test | Nano-Ditech Corporation | 2026-01-15 | 177 | 0 |
| K250398 | Innovita Flu A/B Antigen Rapid Test | Innovita (Tangshan) Biological Technology Co., Ltd. | 2025-07-03 | 141 | 0 |
| K241188 | Acucy® Influenza A&B Test with the Acucy® 2 System | SEKISUI Diagnostics, LLC | 2025-04-18 | 354 | 0 |
| K232434 | BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waive | Bd | 2023-12-05 | 116 | 0 |
| K223016 | BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waiv | Bd | 2023-01-27 | 120 | 0 |
| K192719 | Osom Ultra Plus Flu A&B Test Kit | SEKISUI Diagnostics, LLC | 2020-04-03 | 190 | 0 |
| K191514 | CareStart Flu A&B Plus | Access Bio, Inc. | 2020-02-18 | 256 | 0 |
| K182001 | Acucy Influenza A&B Test with the Acucy System | SEKISUI Diagnostics, LLC | 2018-12-17 | 144 | 0 |
| K182157 | BioSign Flu A+B | Princeton BioMeditech Corp. | 2018-09-18 | 40 | 0 |
| K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader | Alere Scarborough, Inc. | 2018-08-08 | 28 | 0 |
| K180438 | BD Veritor System for Rapid Detection of Flu A + B CLIA waiv | Bd | 2018-03-20 | 28 | 1 |
| K180288 | QuickVue Influenza A+B | Quidel Corporation | 2018-02-13 | 12 | 0 |
| K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere B | Alere Scarborough, Inc. | 2017-12-13 | 30 | 0 |
| K162438 | Sofia Influenza A+B FIA on Sofia 2 | Quidel Corporation | 2017-04-14 | 226 | 0 |
| K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere B | Alere Scarborough, Inc. | 2017-04-10 | 200 | 0 |
| K160164 | BD Veritor System for Rapid Detection of Flu A + B Labratory | Becton, Dickinson & CO | 2016-02-25 | 29 | 0 |
| K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA waiv | Becton, Dickinson & CO | 2016-02-24 | 28 | 0 |
| K153012 | Sofia Influenza A+B FIA | Quidel Corporation | 2016-01-12 | 90 | 0 |
| K152870 | BD Veritor System for the Rapid Detection of Flu A + B CLIA | Becton, Dickinson and Co. | 2015-10-27 | 27 | 0 |
| K152874 | BD Veritor System for the Rapid Detection of Flu A + B Labor | Becton, Dickinson and Co. | 2015-10-27 | 27 | 0 |
| K151291 | BD Veritor (TM) System for the Rapid Detection of Flu A+B | Becton, Dickinson and Company | 2015-06-10 | 26 | 0 |
| K151301 | BD Veritor™ System Flu A+B Assay | Becton, Dickinson and Company | 2015-06-08 | 24 | 0 |
| K133714 | TRU FLU | Meridian Bioscience, Inc. | 2014-01-03 | 29 | 0 |
| K133637 | ALERE INFLUENZA A & B TEST | Alere Scarborough, Inc D/B/A Binax, Inc. | 2013-12-18 | 41 | 0 |
| K133474 | BIOSIGN FLU A + B, STATUS FLU A & B | Princeton BioMeditech Corp. | 2013-12-10 | 28 | 0 |
| K133138 | BD Veritor™ System Flu A+B Assay | Becton, Dickinson & CO | 2013-11-13 | 27 | 0 |
| K132693 | BD Veritor™ System Flu A+B Assay | Becton, Dickinson and Company | 2013-10-02 | 34 | 0 |
| K132692 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2013-09-23 | 25 | 0 |
| K132465 | BIOSIGN FLU A + B, STATUS FLU A & B | Princeton BioMeditech Corp. | 2013-09-09 | 33 | 0 |
| K132256 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2013-08-07 | 19 | 0 |
| K132259 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2013-08-07 | 19 | 0 |
| K121797 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2012-09-07 | 80 | 0 |
| K120049 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2012-03-23 | 77 | 0 |
| K112277 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2011-10-28 | 80 | 0 |
| K112177 | SOFIA ANALYZER AND INFLUENZA A+B FIA | Quidel Corp. | 2011-10-24 | 88 | 1 |
| K103610 | CLEARVIEW EXACT II INFLUENZA A & B TEST | Alere Scarborough, Inc D/B/A Binax, Inc. | 2011-01-06 | 28 | 0 |
| K083746 | BIOSIGN FLU A+B | Princeton BioMeditech Corp. | 2010-11-10 | 693 | 3 |
| K101461 | BD DIRECTIGEN EX FLU A+B | Becton, Dickinson and Company | 2010-06-24 | 29 | 0 |
| K101529 | BD DIRECTIGEN EZ FLU A+B ASSAY | Becton, Dickinson & CO | 2010-06-14 | 12 | 0 |
| K092349 | CLEARVIEW EXACT II INFLUENZA A & B TEST | Inverness Medical, Inc. | 2010-05-10 | 279 | 0 |
| K100227 | SAS FLUALERT A&B, SAS INFLUENZA A TEST | Sa Scientific, Inc. | 2010-02-23 | 28 | 0 |
| K093116 | MODIFICATION TO: RAMP INFLUENZA A/B ASSAY | Response Biomedical Corp. | 2009-10-21 | 19 | 0 |
| K092633 | OSOM INFLUENZA A&B TEST , MODEL PN190 | Genzyme Corporation | 2009-09-25 | 29 | 0 |
| K092698 | QUICKVUE INFLUENZA A+B TEST | Quidel Corp. | 2009-09-15 | 13 | 0 |
| K092553 | TRU FLU, MODEL 751230 | Meridian Bioscience, Inc. | 2009-09-11 | 22 | 0 |
| K092423 | XPECT FLU A & B | Thermo Fisher Scientific | 2009-08-26 | 19 | 0 |
| K092223 | MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST | Binax, Inc. | 2009-08-12 | 20 | 0 |
| K080380 | SAS INFLUENZA A & B TEST | Sa Scientific, Inc. | 2009-07-23 | 526 | 0 |
| K071591 | RAMP INFLUENZA A/B ASSAY | Response Biomedical Corp. | 2008-04-16 | 310 | 0 |
| K071657 | TRU FLU | Meridian Bioscience, Inc. | 2007-11-15 | 150 | 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