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510(k) K260333

LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit by Diasorin Molecular, LLC — Product Code PGX

K260333 is an FDA 510(k) premarket notification submitted by Diasorin Molecular, LLC for the device "LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit". The FDA issued a decision of Substantially Equivalent on June 15, 2026. The device falls under product code PGX (Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System), a Class II device regulated under 21 CFR 866.2680. Diasorin Molecular, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2026
Date Received
February 2, 2026
Clearance Type
Dual Track
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Device Class
Class II
Regulation Number
866.2680
Review Panel
MI
Submission Type

An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.

Other clearances by Diasorin Molecular, LLC

  • 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)
  • K183223 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (December 19, 2018)

Other clearances for product code PGX

  • K201269 — Accula Strep A Test (November 9, 2020)
  • K183366 — GenePOC Strep A (March 6, 2019)
  • K173653 — Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit (May 2, 2018)
  • K173398 — Xpert Xpress Strep A (April 26, 2018)
  • K172402 — ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit (October 30, 2017)
  • K172126 — Xpert Xpress Strep A (September 25, 2017)
  • K162274 — Solana Strep Complete Assay (October 25, 2016)
  • K150868 — Solana GAS Assay, Solana instrument (June 23, 2015)
  • K141757 — ALERE I STREP A (March 31, 2015)
  • K143651 — Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (March 18, 2015)

FDA data resources