Home / 510(k) Clearances / K232286

510(k) K232286

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument by Quidel Corporation — Product Code PGI

K232286 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument". The FDA issued a decision of Substantially Equivalent on December 20, 2023. The device falls under product code PGI (Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples), a Class II device regulated under 21 CFR 866.3309. Quidel Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2023
Date Received
August 1, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Device Class
Class II
Regulation Number
866.3309
Review Panel
MI
Submission Type

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 clearances by Quidel Corporation

  • K231795 — QuickVue COVID-19 Test (March 22, 2024)
  • K233688 — Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set (December 13, 2023)
  • K230349 — Lyra RSV+hMPV Assay (March 10, 2023)
  • DEN220039 — Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set (March 8, 2023)
  • K230236 — Lyra Influenza A+B Assay (March 3, 2023)
  • K211342 — Sofia 2 Campylobacter FIA (November 23, 2021)
  • K173496 — Sofia 2 Lyme FIA, Sofia Lyme Control Set (August 30, 2018)
  • K181029 — Solana Bordetella Complete Assay (July 15, 2018)
  • K173691 — Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack (February 28, 2018)
  • K180288 — QuickVue Influenza A+B (February 13, 2018)

Other clearances for product code PGI

  • K233349 — Alinity m HSV 1 & 2 / VZV (May 3, 2024)
  • K192376 — Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack (November 26, 2019)
  • K180559 — HSV 1 & 2 ELITe MGB Kit; ELITe InGenius (October 29, 2018)
  • K173798 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (March 14, 2018)
  • K162451 — Solana HSV 1+2/VZV Assay (November 28, 2016)
  • K151906 — ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol (October 6, 2015)
  • K151046 — illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control (July 17, 2015)
  • DEN140004 — QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY (May 13, 2014)

FDA data resources