Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3830](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3830) → LSR — Reagent, Borrelia Serological Reagent # LSR · Reagent, Borrelia Serological Reagent _Microbiology · 21 CFR 866.3830 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR ## Overview - **Product Code:** LSR - **Device Name:** Reagent, Borrelia Serological Reagent - **Regulation:** [21 CFR 866.3830](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3830) - **Device Class:** 2 - **Review Panel:** [Microbiology](/submissions/MI) ## 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. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252627](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K252627.md) | Lyme-ID IgG Test; Bio-ID800 | Inanovate, Inc. | Nov 14, 2025 | SESE | | [K242872](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K242872.md) | iDart Lyme IgM ImmunoBlot Kit | Id-Fish Technology, Inc. | Jun 12, 2025 | SESE | | [K233367](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K233367.md) | iDart Lyme IgG ImmunoBlot Kit | Id-Fish Technology, Inc. | Aug 12, 2024 | SESE | | [K230863](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K230863.md) | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit | Zeus Scientific | Jul 13, 2023 | SESE | | [K220016](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K220016.md) | Viramed Borrela All-In-One ViraChip Test Kit | Viramed Biotech AG | Aug 19, 2022 | SESE | | [K203296](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K203296.md) | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics | Mar 22, 2021 | SESE | | [K203295](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K203295.md) | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics | Mar 22, 2021 | SESE | | [K203292](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K203292.md) | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | Mar 22, 2021 | SESE | | [K203289](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K203289.md) | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | Mar 22, 2021 | SESE | | [K202574](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K202574.md) | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus | DiaSorin, Inc. | Feb 18, 2021 | SESE | | [K202573](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K202573.md) | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus | DiaSorin, Inc. | Feb 18, 2021 | SESE | | [K200025](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K200025.md) | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | Gold Standard Diagnostics | Apr 6, 2020 | SESE | | [K200023](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K200023.md) | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | Gold Standard Diagnostics | Apr 6, 2020 | SESE | | [K193051](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K193051.md) | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set | DiaSorin, Inc. | Jan 29, 2020 | SESE | | [K191398](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K191398.md) | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System | Zeus Scientific, Inc. | Jul 29, 2019 | SESE | | [K191240](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K191240.md) | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System | Zeus Scientific, Inc. | Jul 29, 2019 | SESE | | [K190907](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K190907.md) | ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System | Zeus Scientific, Inc. | Jul 29, 2019 | SESE | | [K183446](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K183446.md) | BioPlex 2200 Lyme Total | Bio-Rad Laboratories | Mar 12, 2019 | SESE | | [K173496](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K173496.md) | Sofia 2 Lyme FIA, Sofia Lyme Control Set | Quidel Corporation | Aug 30, 2018 | SESE | | [K180264](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K180264.md) | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | Gold Standard Diagnostics | May 2, 2018 | SESE | ## Top Applicants - Zeus Scientific, Inc. — 12 clearances - Gold Standard Diagnostics — 9 clearances - Viramed Biotech AG — 7 clearances - Mardx Diagnostics, Inc. — 6 clearances - Whittaker Bioproducts, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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