cobas HSV 1 and 2 Test
FDA 510(k) K150617 · Roche Molecular Systems, Inc.
510(k) numberK150617
Submission
- Device name
- cobas HSV 1 and 2 Test
- Applicant
- Roche Molecular Systems, Inc.
Pleasanton, CA, US - Received
- March 10, 2015
- Decision date
- June 1, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OQO – Herpes Simplex Virus Nucleic Acid Amplification Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens.
Other 510(k)s with product code OQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172509 | Sentosa SA201 HSV 1/2 Qualitative PCR TestOQO · Traditional | Vela Diagnostics USA, Inc. | 02/01/2018SE |
| K162673 | Aptima Herpes Simplex Viruses 1 & 2 AssayOQO · Traditional | Hologic, Inc. | 06/15/2017SE |
| K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackOQO · Traditional | Focus Diagnostics | 08/28/2015SE |
| K142156 | Seegene Anyplex II HSV-1/2 AssayOQO · Traditional | Seegene | 02/13/2015SE |
| K142738 | artus HSV-1/2 QS-RGQ MDx KitOQO · Traditional | Qiagen | 12/19/2014SE |
| K140198 | Imdx HSV-1/2 for Abbott M2000OQO · Traditional | Intelligent Medical Devices, Inc. | 05/13/2014SE |
| K140029 | Amiplivue HSV 1&2 AssayOQO · Traditional | Quidel Corporation | 03/26/2014SE |
| K111951 | Isoamp HSV AssayOQO · Traditional | Biohelix Corporation | 09/27/2011SE |
| K111527 | Multicode-Rtx Herpes Simplex Virus 1 & 2 KitOQO · Traditional | Eragen Biosciences, Inc. | 08/03/2011SE |
| K103798 | BD Probetec Herpes Simplex Viruses (HSV 1& 2) Q Amplified DNA AssaysOQO · Traditional | Becton, Dickinson & CO | 03/18/2011SE |
More from Becton, Dickinson & CO
| 510(k) | Device | Decision |
|---|---|---|
| K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…PGX · Traditional | 08/28/2026SE |
| K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…OZN · Traditional | 08/28/2026SE |
| K260021 | cobas® BV/CVPQA · Traditional | 07/16/2026SE |
| K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…QEP · Traditional | 07/08/2026SE |
| K253759 | cobas liat CT/NG/MG nucleic acid testQEP · Dual Track | 05/15/2026SE |
| K253756 | cobas liat CT/NG nucleic acid testQEP · Dual Track | 05/15/2026SE |
| K243753 | cobas liat Bordetella panel nucleic acid testOZZ · Dual Track | 11/20/2025SE |
| K252484 | cobas HCVMZP · Traditional | 11/03/2025SE |
| K252481 | cobas CMVPAB · Traditional | 11/03/2025SE |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF · Traditional | 07/31/2025SE |
Questions and answers
When was cobas HSV 1 and 2 Test cleared by the FDA?
cobas HSV 1 and 2 Test (K150617) received a 510(k) decision of Substantially Equivalent on June 1, 2015, 83 days after the submission was received.
What is the product code of K150617?
The FDA product code is OQO – Herpes Simplex Virus Nucleic Acid Amplification Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3305.