Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
OZE — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
249 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: | Centers for Disease Control and Prevention | 2025-07-11 | 268 | 0 |
| K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: | Centers for Disease Control and Prevention | 2025-03-14 | 84 | 0 |
| K241110 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, | Centers for Disease Control and Prevention | 2024-05-21 | 29 | 0 |
| K230236 | Lyra Influenza A+B Assay | Quidel Corporation | 2023-03-03 | 32 | 0 |
| K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A | Abbott Diagnostics Scarborough, Inc. | 2022-06-24 | 98 | 0 |
| K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, | Centers for Disease Control and Prevention | 2020-03-10 | 25 | 1 |
| K182513 | FluChip-8G Influenza A+B Assay | Indevr, Inc. | 2019-04-22 | 222 | 0 |
| K190302 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, | Centers for Disease Control and Prevention | 2019-03-27 | 43 | 0 |
| K190204 | ID NOW Influenza A & B 2 | Alere Scarborough, Inc. | 2019-03-18 | 42 | 0 |
| K181736 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: | Centers For Disease Control and Prevention (CDC) | 2018-07-30 | 28 | 0 |
| K171641 | Accula Flu A/Flu B Test | Mesa Biotech, Inc. | 2018-02-06 | 249 | 0 |
| K172091 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, | Centers for Disease Control and Prevention | 2017-08-09 | 29 | 0 |
| K161556 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, | Centers For Disease Control and Prevention (CDC) | 2016-06-30 | 24 | 0 |
| K153148 | CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel | Centers For Disease Control and Prevention (CDC) | 2015-12-01 | 32 | 0 |
| K141859 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, | Centers for Disease Control and Prevention | 2014-08-01 | 22 | 0 |
| K140857 | INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRU | Centers for Disease Control and Prevention | 2014-04-25 | 22 | 0 |
| K133869 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, | Center For Disease Control and Prevention (Cdc) | 2014-01-17 | 28 | 0 |
| K132508 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Centers for Disease Control and Prevention | 2013-09-23 | 42 | 0 |
| K131728 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Quidel Corp. | 2013-08-29 | 78 | 0 |
| K113777 | QUIDEL MOLECULAR INFLUENZA A+B | Quidel Corp. | 2012-03-15 | 85 | 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