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510(k) K033070

BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM by Trinity Biotech USA — Product Code LSR

K033070 is an FDA 510(k) premarket notification submitted by Trinity Biotech USA for the device "BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on November 26, 2003. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Trinity Biotech USA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2003
Date Received
September 29, 2003
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 Trinity Biotech USA

  • K140455 — CAPTIA MEASLES IGM (May 22, 2014)
  • K033106 — CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT (July 13, 2004)
  • K033105 — CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT (July 13, 2004)
  • K033083 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (November 26, 2003)
  • K033067 — PYLORI IGG (November 26, 2003)
  • K033079 — CHLAMYDIA IGG ELISA TEST SYSTEM (November 26, 2003)
  • K033051 — LEGIONELLA PNEUMOPHILA IGG/IGM (November 26, 2003)
  • K033064 — MYCOPLASMA IGG (November 26, 2003)
  • K993839 — ENA PROFILE ELISA TEST SYSTEM (January 12, 2000)
  • K992665 — MACRA LP(A) ENZYME IMMUNOASSAY KIT (November 26, 1999)

Other clearances for product code LSR

  • K254295 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA (July 10, 2026)
  • 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)
  • 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)

FDA data resources