Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QFO · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200506 | DPP Zika IgM System, DPP Zika IgM System Control Pack, and D | Chembio Diagnostic Systems | 2020-06-03 | 93 | 0 |
| K192046 | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture I | DiaSorin, Inc. | 2019-10-28 | 89 | 0 |
| K191578 | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), | Siemens Healthcare Diagnostics, Inc. | 2019-07-17 | 33 | 0 |
| DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA | InBios International, Inc. | 2019-05-23 | 148 | 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