Alinity m HSV 1 & 2 / VZV
FDA 510(k) K233349 · Abbott Molecular, Inc.
510(k) numberK233349
Submission
- Device name
- Alinity m HSV 1 & 2 / VZV
- Applicant
- Abbott Molecular, Inc.
Des Plaines, IL, US - Received
- September 29, 2023
- Decision date
- May 3, 2024
- 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.
Other 510(k)s with product code PGI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusPGI · Traditional | Elitechgroup | 10/29/2018SE |
| K173798 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackPGI · Traditional | Diasorin Molecular, LLC | 03/14/2018SE |
| K162451 | Solana HSV 1+2/VZV AssayPGI · Traditional | Quidel Corporation | 11/28/2016SE |
| 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 |
More from Meridian Bioscience, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252102 | Alinity m HCVMZP · Traditional | 09/25/2025SE |
| K243489 | Alinity m EBV (09N43-095)QLX · Traditional | 07/28/2025SE |
| K243485 | Alinity m CMVPAB · Traditional | 07/01/2025SE |
| K241921 | Alinity m BKVQMI · Traditional | 03/24/2025SE |
| K241573 | Alinity m Resp-4-PlexQOF · Traditional | 02/14/2025SE |
| K243410 | simpli-COLLECT STI TestQYA · Traditional | 01/30/2025SE |
| K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)QQX · Traditional | 12/06/2024SE |
| K222379 | Alinity m STI AssayQEP · Traditional | 03/03/2023SE |
| K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085)…QLX · Traditional | 07/15/2022SE |
| K202977 | Alinity m STI AssayQEP · Traditional | 04/29/2022SE |
Questions and answers
When was Alinity m HSV 1 & 2 / VZV cleared by the FDA?
Alinity m HSV 1 & 2 / VZV (K233349) received a 510(k) decision of Substantially Equivalent on May 3, 2024, 217 days after the submission was received.
What is the product code of K233349?
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.