ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
FDA 510(k) K213987 · Biokit, S.A.
510(k) numberK213987
Submission
- Device name
- ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
- Applicant
- Biokit, S.A.
Lliçà D´Amunt, ES - Received
- December 20, 2021
- Decision date
- September 20, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MXJ – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
Other 510(k)s with product code MXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220923 | Elecsys HSV-1 IgG (08948844160)MXJ · Traditional | Roche Diagnostics | 10/12/2022SE |
| K181333 | ADVIA Centaur Herpes-1 IgGMXJ · Traditional | Biokit, S.A. | 08/23/2018SE |
| K162276 | SeraQuest Herpes Type 1 Specific IgGMXJ · Traditional | Quest International, Inc. | 10/01/2016SE |
| K143236 | Theranos Herpes Simplex Virus-1 IgG AssayMXJ · Traditional | Theranos, Inc. | 07/02/2015SE |
| K131334 | Herpes Simplex Virus Type 1 Igg Elisa TestMXJ · Traditional | Gold Standard Diagnostics | 02/28/2014SE |
| K120625 | Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSVMXJ · Traditional | Roche Diagnostics | 07/25/2012SE |
| K120959 | Bioplex 2200 HSV-1 and HSV-2 Igg KitMXJ · Traditional | Bio-Rad Laboratories | 06/22/2012SE |
| K103363 | Zeus Elisa HSV Gc-I Igg Test SystemMXJ · Traditional | Zeus Scientific, Inc. | 04/26/2011SE |
| K090409 | Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection SystemMXJ · Traditional | Bio-Rad Laboratories | 05/08/2009SE |
| K081685 | Liaison HSV-1 Type Specific Igg Assay, Control HSV-1 IggMXJ · Traditional | DiaSorin, Inc. | 11/18/2008SE |
More from DiaSorin, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsMYF · Traditional | 02/12/2025SE |
| K233606 | ADVIA Centaur EBV-VCA IgMLSE · Traditional | 08/07/2024SE |
| K233605 | ADVIA Centaur EBV-EBNA IgGLLM · Traditional | 08/07/2024SE |
| 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-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls cleared by the FDA?
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls (K213987) received a 510(k) decision of Substantially Equivalent on September 20, 2023, 639 days after the submission was received.
What is the product code of K213987?
The FDA product code is MXJ – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1, a Class II (moderate risk) device regulated under 21 CFR 866.3305.