Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MYF · Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
195 daysmedian FDA review time
421 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITE | Biokit, S.A. | 2025-02-12 | 85 | 0 |
| K220924 | Elecsys HSV-2 IgG (08948887160) | Roche Diagnostics | 2022-10-12 | 195 | 0 |
| K181514 | SeraQuest HSV Type 2 Specific IgG | Quest International, Inc. | 2019-06-13 | 370 | 0 |
| K181334 | ADVIA Centaur Herpes-2 IgG | Biokit, S.A. | 2018-08-23 | 94 | 1 |
| K152353 | SeraQuest HSV Type 2 Specific IgG | Quest International, Inc. | 2016-05-13 | 267 | 0 |
| K103603 | ZEUS ELISA HSV GG-2 IGG TEST SYSTEM | Zeus Scientific, Inc. | 2011-05-20 | 163 | 0 |
| K081687 | LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG | DiaSorin, Inc. | 2008-11-10 | 146 | 1 |
| K061239 | EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) | Euroimmun Us, LLC | 2007-06-28 | 421 | 0 |
| K033106 | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT | Trinity Biotech USA | 2004-07-13 | 287 | 0 |
| K993724 | HSV-2 ELISA IGG, MODEL EL0920G | Mrl Diagnostics | 2000-02-01 | 90 | 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