Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GNX — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
374 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133411 | ALERE BINAXNOW INFLUENZA A & B CARD | Alere Scarborough, Inc D/B/A Binax, Inc. | 2013-12-05 | 28 | 0 |
| K132352 | SAS FLUALERT A & B, SAS INFLUENZA A TEST | Sa Scientific , Ltd. | 2013-08-22 | 24 | 0 |
| K131804 | REMEL XPECT FLU A&B | Remel, Inc. | 2013-07-12 | 23 | 0 |
| K131599 | QUICK VUE INFLUENZA | Quidel Corporation | 2013-07-05 | 32 | 0 |
| K131606 | SOFIA INFLUENZA A+B FIA | Quidel Corp. | 2013-07-05 | 32 | 0 |
| K131619 | QUICKVUE INFLUENZA A+B | Quidel Corp. | 2013-06-28 | 25 | 0 |
| K123182 | OSOM INFLUENZA A&B TEST MODEL 190 | SEKISUI Diagnostics, LLC | 2012-11-05 | 26 | 0 |
| K971494 | VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUS | Zymetx, Inc. | 1997-09-10 | 139 | 0 |
| K924006 | BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY | Baxter Healthcare Corp | 1992-12-29 | 141 | 0 |
| K901493 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B | Whittaker Bioproducts, Inc. | 1990-06-27 | 90 | 0 |
| K893579 | FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A | Whittaker Bioproducts, Inc. | 1990-01-16 | 252 | 0 |
| K884191 | INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION | Baxter Diagnostics, Inc. | 1988-11-22 | 47 | 0 |
| K872958 | IMAGEN INFLUENZA VIRUS A AND B TESTMI | Boots-Celltech Diagnostics, Inc. | 1988-02-24 | 210 | 0 |
| K871231 | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 | 91 | 0 |
| K871233 | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 | 91 | 0 |
| K843659 | INFLUENZA A2 VIRUS | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K843660 | IN FLUENZA B VIRUS | Institute Virion , Ltd. | 1985-09-26 | 374 | 0 |
| K802931 | INFLUENZA A & B S-ANTIGEN & CONTROLS | Orion Diagnostica, Inc. | 1981-01-12 | 54 | 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