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510(k) K173798

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack by Diasorin Molecular, LLC — Product Code PGI

K173798 is an FDA 510(k) premarket notification submitted by Diasorin Molecular, LLC for the device "Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack". The FDA issued a decision of Substantially Equivalent on March 14, 2018. 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. Diasorin Molecular, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2018
Date Received
December 14, 2017
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 Diasorin Molecular, LLC

  • K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit (June 15, 2026)
  • K251978 — LIAISON NES FLU A/B, RSV & COVID-19 (December 23, 2025)
  • K252387 — Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B (October 30, 2025)
  • DEN230092 — Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. a (July 15, 2024)
  • K220963 — Simplexa COVID-19 & Flu A/B Direct (March 17, 2023)
  • K202755 — Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack (November 5, 2022)
  • K212147 — Simplexa COVID-19 Direct (September 13, 2022)
  • K201505 — Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pa (August 22, 2020)
  • K192376 — Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack (November 26, 2019)
  • K190219 — Simplexa VZV Direct, Simplexa VZV Positive Control Pack (May 13, 2019)

Other clearances for product code PGI

  • K233349 — Alinity m HSV 1 & 2 / VZV (May 3, 2024)
  • K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument (December 20, 2023)
  • 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)
  • 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