Solana HSV 1+2/VZV Assay
FDA 510(k) K162451 · Quidel Corporation
510(k) numberK162451
Submission
- Device name
- Solana HSV 1+2/VZV Assay
- Applicant
- Quidel Corporation
Athens, OH, US - Received
- September 1, 2016
- Decision date
- November 28, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PGI – Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3309
- Specialty
- Microbiology
For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid.
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|---|---|---|---|
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| K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentPGI · Traditional | Quidel Corporation | 12/20/2023SE |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackPGI · Traditional | Diasorin Molecular, LLC | 11/26/2019SE |
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| K173798 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackPGI · Traditional | Diasorin Molecular, LLC | 03/14/2018SE |
| K151906 | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File…PGI · Traditional | Luminex Corporation | 10/06/2015SE |
| K151046 | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit…PGI · Traditional | Meridian Bioscience, Inc. | 07/17/2015SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K231795 | QuickVue COVID-19 TestQYT · Traditional | 03/22/2024SE |
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Questions and answers
When was Solana HSV 1+2/VZV Assay cleared by the FDA?
Solana HSV 1+2/VZV Assay (K162451) received a 510(k) decision of Substantially Equivalent on November 28, 2016, 88 days after the submission was received.
What is the product code of K162451?
The FDA product code is PGI – Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples, a Class II (moderate risk) device regulated under 21 CFR 866.3309.