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510(k) K162274

Solana Strep Complete Assay by Quidel Corporation — Product Code PGX

K162274 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "Solana Strep Complete Assay". The FDA issued a decision of Substantially Equivalent on October 25, 2016. 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. Quidel Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2016
Date Received
August 12, 2016
Clearance Type
Traditional
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 Quidel Corporation

  • K231795 — QuickVue COVID-19 Test (March 22, 2024)
  • K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument (December 20, 2023)
  • 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)

Other clearances for product code PGX

  • K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit (June 15, 2026)
  • 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)
  • 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