Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
FDA 510(k) K173798 · Diasorin Molecular, LLC
510(k) numberK173798
Submission
- Device name
- Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
- Applicant
- Diasorin Molecular, LLC
Cypress, CA, US - Received
- December 14, 2017
- Decision date
- March 14, 2018
- 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 |
|---|---|---|---|
| K233349 | Alinity m HSV 1 & 2 / VZVPGI · Traditional | Abbott Molecular, Inc. | 05/03/2024SE |
| 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 |
| 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 |
|---|---|---|
| K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitPGX · Dual Track | 06/15/2026SE |
| K251978 | Liaison Nes Flu A/B, RSV & COVID-19QOF · Dual Track | 12/23/2025SE |
| K252387 | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV…QOF · Traditional | 10/30/2025SE |
| K220963 | Simplexa COVID-19 & Flu A/B DirectQOF · Traditional | 03/17/2023SE |
| K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackQDZ · Traditional | 11/05/2022SE |
| K212147 | Simplexa COVID-19 DirectQQX · Traditional | 09/13/2022SE |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control PackOCC · Traditional | 08/22/2020SE |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackPGI · Traditional | 11/26/2019SE |
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control PackPLO · Traditional | 05/13/2019SE |
| K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackOZZ · Special | 12/19/2018SE |
Questions and answers
When was Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack cleared by the FDA?
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (K173798) received a 510(k) decision of Substantially Equivalent on March 14, 2018, 90 days after the submission was received.
What is the product code of K173798?
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.