LSR · Reagent, Borrelia Serological Reagent

Microbiology · 21 CFR 866.3830 · Class 2

Overview

Product CodeLSR
Device NameReagent, Borrelia Serological Reagent
Regulation21 CFR 866.3830
Device ClassClass 2
Review PanelMicrobiology

Identification

Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

Classification Rationale

Class II (performance standards).

Recent Cleared Devices (20 of 111)

Showing 20 most recent of 111 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K252627Lyme-ID IgG Test; Bio-ID800Inanovate, Inc.Nov 14, 2025SESE
K242872iDart Lyme IgM ImmunoBlot KitId-Fish Technology, Inc.Jun 12, 2025SESE
K233367iDart Lyme IgG ImmunoBlot KitId-Fish Technology, Inc.Aug 12, 2024SESE
K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitZeus ScientificJul 13, 2023SESE
K220016Viramed Borrela All-In-One ViraChip Test KitViramed Biotech AGAug 19, 2022SESE
K203296Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitGold Standard DiagnosticsMar 22, 2021SESE
K203295Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitGold Standard DiagnosticsMar 22, 2021SESE
K203292Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitGold Standard DiagnosticsMar 22, 2021SESE
K203289Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitGold Standard DiagnosticsMar 22, 2021SESE
K202574LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusDiaSorin, Inc.Feb 18, 2021SESE
K202573LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody PlusDiaSorin, Inc.Feb 18, 2021SESE
K200025Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitGold Standard DiagnosticsApr 6, 2020SESE
K200023Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitGold Standard DiagnosticsApr 6, 2020SESE
K193051LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control SetDiaSorin, Inc.Jan 29, 2020SESE
K191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemZeus Scientific, Inc.Jul 29, 2019SESE
K191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemZeus Scientific, Inc.Jul 29, 2019SESE
K190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemZeus Scientific, Inc.Jul 29, 2019SESE
K183446BioPlex 2200 Lyme TotalBio-Rad LaboratoriesMar 12, 2019SESE
K173496Sofia 2 Lyme FIA, Sofia Lyme Control SetQuidel CorporationAug 30, 2018SESE
K180264Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitGold Standard DiagnosticsMay 2, 2018SESE

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