Aptima Herpes Simplex Viruses 1 & 2 Assay
FDA 510(k) K162673 · Hologic, Inc.
510(k) numberK162673
Submission
- Device name
- Aptima Herpes Simplex Viruses 1 & 2 Assay
- Applicant
- Hologic, Inc.
San Diego, CA, US - Received
- September 26, 2016
- Decision date
- June 15, 2017
- 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.
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|---|---|---|---|
| K172509 | Sentosa SA201 HSV 1/2 Qualitative PCR TestOQO · Traditional | Vela Diagnostics USA, Inc. | 02/01/2018SE |
| K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackOQO · Traditional | Focus Diagnostics | 08/28/2015SE |
| K150617 | cobas HSV 1 and 2 TestOQO · Traditional | Roche Molecular Systems, Inc. | 06/01/2015SE |
| 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 |
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Questions and answers
When was Aptima Herpes Simplex Viruses 1 & 2 Assay cleared by the FDA?
Aptima Herpes Simplex Viruses 1 & 2 Assay (K162673) received a 510(k) decision of Substantially Equivalent on June 15, 2017, 262 days after the submission was received.
What is the product code of K162673?
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.