Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
The Herpes Virus (VZV, HSV1, HSV2) DNA Detection Assay is an in vitro diagnostic device for the qualitative detection and differentiation of VZV, HSV1, and HSV2 DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. It is an FDA Class 2 device regulated under 21 CFR 866.3309, requiring 510(k) clearance, within the Microbiology (MI) specialty. The product code is PGI. This assay is not intended for use with cerebrospinal fluid specimens.
Basic Information
- Product Code
- PGI
- Device Class
- FDA class 2
- Regulation Number
- 866.3309
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233349 | Alinity m HSV 1 & 2 / VZV | May 03, 2024 | Substantially Equivalent | Abbott Molecular, Inc. |
| K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | Dec 20, 2023 | Substantially Equivalent | Quidel Corporation |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack | Nov 26, 2019 | Substantially Equivalent | Diasorin Molecular, LLC |
| K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | Oct 29, 2018 | Substantially Equivalent | Elitechgroup |
| K173798 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | Mar 14, 2018 | Substantially Equivalent | Diasorin Molecular, LLC |
| K162451 | Solana HSV 1+2/VZV Assay | Nov 28, 2016 | Substantially Equivalent | Quidel Corporation |
| K151906 | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD) | Oct 06, 2015 | Substantially Equivalent | Luminex Corporation |
| K151046 | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 | Jul 17, 2015 | Substantially Equivalent | Meridian Bioscience, Inc. |
| DEN140004 | QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY | May 13, 2014 | Unknown | Diagnostic Hybrids, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.