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510(k) K254295

Sofia Lyme FIA; Sofia 2 Campylobacter FIA by Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) — Product Code LSR

K254295 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) for the device "Sofia Lyme FIA; Sofia 2 Campylobacter FIA". The FDA issued a decision of Substantially Equivalent on July 10, 2026. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2026
Date Received
December 31, 2025
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

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  • 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)
  • 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)
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FDA data resources