Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MXJ — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
154 daysmedian FDA review time
298 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITE | Biokit, S.A. | 2023-09-20 | 639 | 0 |
| K220923 | Elecsys HSV-1 IgG (08948844160) | Roche Diagnostics | 2022-10-12 | 195 | 0 |
| K181333 | ADVIA Centaur Herpes-1 IgG | Biokit, S.A. | 2018-08-23 | 94 | 0 |
| K162276 | SeraQuest Herpes Type 1 Specific IgG | Quest International, Inc. | 2016-10-01 | 50 | 0 |
| K143236 | Theranos Herpes Simplex Virus-1 IgG Assay | Theranos, Inc. | 2015-07-02 | 232 | 0 |
| K131334 | HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST | Gold Standard Diagnostics | 2014-02-28 | 295 | 0 |
| K120625 | ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV | Roche Diagnostics | 2012-07-25 | 146 | 0 |
| K120959 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT | Bio-Rad Laboratories | 2012-06-22 | 84 | 0 |
| K103363 | ZEUS ELISA HSV GC-I IGG TEST SYSTEM | Zeus Scientific, Inc. | 2011-04-26 | 160 | 0 |
| K090409 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-A | Bio-Rad Laboratories | 2009-05-08 | 79 | 0 |
| K081685 | LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG | DiaSorin, Inc. | 2008-11-18 | 154 | 0 |
| K072178 | ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM | Zeus Scientific, Inc. | 2008-05-30 | 298 | 0 |
| K071511 | PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MO | Focus Diagnostics, Inc. | 2007-10-05 | 123 | 0 |
| K071510 | HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODEL | Focus Diagnostics, Inc. | 2007-09-24 | 112 | 0 |
| K062543 | HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G | Focus Diagnostics, Inc. | 2007-02-01 | 155 | 0 |
| K033105 | CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT | Trinity Biotech USA | 2004-07-13 | 287 | 0 |
| K021486 | HERPESELECT 2 ELISA IGG, MODEL ELO920G | Focus Technologies, Inc. | 2002-08-01 | 90 | 0 |
| K021429 | HERPESELECT 1 ELISA IGG, MODEL EL0910G | Focus Technologies, Inc. | 2002-07-29 | 87 | 0 |
| K993754 | HSV-1 ELISA IGG, MODEL EL0910G | Mrl Diagnostics | 2000-02-09 | 96 | 0 |
| K984343 | PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST | Meridian Diagnostics, Inc. | 1999-06-25 | 203 | 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