Home / 510(k) Clearances / K252387

510(k) K252387

Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) by Diasorin Molecular, LLC — Product Code QOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2025
Date Received
July 31, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Device Class
Class II
Regulation Number
866.3981
Review Panel
MI
Submission Type

A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.

Other clearances by Diasorin Molecular, LLC

  • K251978 — LIAISON NES FLU A/B, RSV & COVID-19 (December 23, 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)
  • K183223 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (December 19, 2018)
  • K182467 — Simplexa GBS Direct, Simplexa GBS Positive Control Pack (November 7, 2018)

Other clearances for product code QOF

  • K251742 — VELO Respiratory Test (February 13, 2026)
  • K251978 — LIAISON NES FLU A/B, RSV & COVID-19 (December 23, 2025)
  • K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini (August 27, 2025)
  • K243544 — BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini (August 14, 2025)
  • K243455 — cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (July 31, 2025)
  • K250995 — Xpert Xpress CoV-2/Flu/RSV plus (May 1, 2025)
  • K250996 — Xpert Xpress CoV-2/Flu/RSV plus (May 1, 2025)
  • K243406 — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (April 25, 2025)
  • K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (April 25, 2025)
  • K242526 — Visby Medical Respiratory Health Test (February 19, 2025)