Home / 510(k) Clearances / K163713

510(k) K163713

Sofia Lyme FIA, Sofia Lyme Control Set by Quidel Corporation — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2017
Date Received
December 30, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Borrelia Serological Reagent
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

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 LSR

  • K252627 — Lyme-ID IgG Test; Bio-ID800 (November 14, 2025)
  • K242872 — iDart Lyme IgM ImmunoBlot Kit (June 12, 2025)
  • K233367 — iDart Lyme IgG ImmunoBlot Kit (August 12, 2024)
  • K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia Vl (July 13, 2023)
  • K220016 — Viramed Borrela All-In-One ViraChip Test Kit (August 19, 2022)
  • K203292 — Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (March 22, 2021)
  • K203296 — Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (March 22, 2021)
  • K203295 — Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (March 22, 2021)
  • K203289 — Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit (March 22, 2021)
  • K202573 — LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)