Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NOP — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
136 daysmedian FDA review time
442 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | Euroimmun Us, Inc. | 2016-08-12 | 269 | 0 |
| K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG) | Euroimmun Us, Inc. | 2016-08-10 | 268 | 0 |
| K052519 | SPECTRAL WEST NILE VIRUS IGM STATUS TEST | Spectral Diagnostics, Inc. | 2006-11-30 | 442 | 0 |
| K041817 | WEST NILE DETECT IGM ELISA | Inbios Intl., Inc. | 2004-11-19 | 136 | 0 |
| K041068 | WEST NILE VIRUS IGG INDIRECT ELISA | Panbio Limited | 2004-10-20 | 177 | 0 |
| K041231 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M | Panbio Limited | 2004-08-10 | 92 | 1 |
| K040854 | WEST NILE VIRUS IGM CAPTURE ELISA | Focus Technologies, Inc. | 2004-06-30 | 90 | 0 |
| K031952 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M | Focus Technologies, Inc. | 2003-10-22 | 119 | 0 |
| K031953 | WEST NILE VIRUS ELISA IGG, MODEL EL0300G | Focus Technologies, Inc. | 2003-10-22 | 119 | 1 |
| DEN030004 | WEST NILE VIRUS IGM CAPTURE ELISA | Panbio Limited | 2003-07-08 | 5 | 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