Elecsys HSV-2 IgG (08948887160)
FDA 510(k) clearance K220924 · decided 2022-10-12
Clearance details
- K-number
- K220924
- Device name
- Elecsys HSV-2 IgG (08948887160)
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2022-03-31
- Decision date
- 2022-10-12
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- MYF
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls (K243575) | Biokit, S.A. | 2025-02-12 |
| SeraQuest HSV Type 2 Specific IgG (K181514) | Quest International, Inc. | 2019-06-13 |
| ADVIA Centaur Herpes-2 IgG (K181334) | Biokit, S.A. | 2018-08-23 |
| SeraQuest HSV Type 2 Specific IgG (K152353) | Quest International, Inc. | 2016-05-13 |
| ZEUS ELISA HSV GG-2 IGG TEST SYSTEM (K103603) | Zeus Scientific, Inc. | 2011-05-20 |
| LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG (K081687) | DiaSorin, Inc. | 2008-11-10 |
| EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT (K061239) | Euroimmun Us, LLC | 2007-06-28 |
| CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT (K033106) | Trinity Biotech USA | 2004-07-13 |
| HSV-2 ELISA IGG, MODEL EL0920G (K993724) | Mrl Diagnostics | 2000-02-01 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |