Theranos Herpes Simplex Virus-1 IgG Assay
FDA 510(k) K143236 · Theranos, Inc.
510(k) numberK143236
Submission
- Device name
- Theranos Herpes Simplex Virus-1 IgG Assay
- Applicant
- Theranos, Inc.
Palo Alto, CA, US - Received
- November 12, 2014
- Decision date
- July 2, 2015
- 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 |
|---|---|---|---|
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsMXJ · Traditional | Biokit, S.A. | 09/20/2023SE |
| 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 |
| 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 |
Questions and answers
When was Theranos Herpes Simplex Virus-1 IgG Assay cleared by the FDA?
Theranos Herpes Simplex Virus-1 IgG Assay (K143236) received a 510(k) decision of Substantially Equivalent on July 2, 2015, 232 days after the submission was received.
What is the product code of K143236?
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.