ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
FDA 510(k) K243575 · Biokit, S.A.
510(k) numberK243575
Submission
- Device name
- ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
- Applicant
- Biokit, S.A.
Lliçà DAmunt, Barcelona, ES - Received
- November 19, 2024
- Decision date
- February 12, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MYF – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
Other 510(k)s with product code MYF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220924 | Elecsys HSV-2 IgG (08948887160)MYF · Traditional | Roche Diagnostics | 10/12/2022SE |
| K181514 | SeraQuest HSV Type 2 Specific IgGMYF · Traditional | Quest International, Inc. | 06/13/2019SE |
| K181334 | ADVIA Centaur Herpes-2 IgGMYF · Traditional | Biokit, S.A. | 08/23/2018SE |
| K152353 | SeraQuest HSV Type 2 Specific IgGMYF · Traditional | Quest International, Inc. | 05/13/2016SE |
| K103603 | Zeus Elisa HSV GG-2 Igg Test SystemMYF · Traditional | Zeus Scientific, Inc. | 05/20/2011SE |
| K081687 | Liaison HSV-2 Type Specific Igg Assay, Control HSV-2 IggMYF · Traditional | DiaSorin, Inc. | 11/10/2008SE |
| K061239 | Euroimmun ANTI-HSV-2 Elisa (Igg) and ANTI-HSV-1 Elisa (Igg) KitMYF · Traditional | Euroimmun Us, LLC | 06/28/2007SE |
| K033106 | Captia HSV 2 Igg Type Specific Elisa KitMYF · Traditional | Trinity Biotech USA | 07/13/2004SE |
| K993724 | HSV-2 Elisa Igg, Model EL0920GMYF · Traditional | Mrl Diagnostics | 02/01/2000SE |
More from Mrl Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K233606 | ADVIA Centaur EBV-VCA IgMLSE · Traditional | 08/07/2024SE |
| K233605 | ADVIA Centaur EBV-EBNA IgGLLM · Traditional | 08/07/2024SE |
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsMXJ · Traditional | 09/20/2023SE |
| K214068 | Quantia IgEDGC · Special | 02/21/2023SE |
| K181334 | ADVIA Centaur Herpes-2 IgGMYF · Traditional | 08/23/2018SE |
| K181333 | ADVIA Centaur Herpes-1 IgGMXJ · Traditional | 08/23/2018SE |
| K152185 | Architect SHBGCDZ · Traditional | 02/11/2016SE |
| K132400 | Lp(A) Calibrators, and Lp(A) ControlsJIT · Abbreviated | 12/19/2013SE |
| K123947 | Architect IvancomycinLEH · Traditional | 08/29/2013SE |
| K110619 | Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D ControlsMRG · Traditional | 11/23/2011SE |
Questions and answers
When was ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls cleared by the FDA?
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls (K243575) received a 510(k) decision of Substantially Equivalent on February 12, 2025, 85 days after the submission was received.
What is the product code of K243575?
The FDA product code is MYF – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.