LSR · Class II · 21 CFR 866.3830

FDA Product Code LSR: Reagent, Borrelia Serological Reagent

Leading manufacturers include Zeus Scientific, Inc., Gold Standard Diagnostics and Viramed Biotech AG.

112
Total
112
Cleared
177d
Avg days
1987
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 180d avg (recent)

FDA 510(k) Cleared Reagent, Borrelia Serological Reagent Devices (Product Code LSR)

112 devices
1–24 of 112
Cleared Jul 10, 2026
Sofia Lyme FIA
K254295
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
Microbiology · 191d
Cleared Nov 14, 2025
Lyme-ID IgG Test
K252627
Inanovate, Inc.
Microbiology · 86d
Cleared Jun 12, 2025
iDart Lyme IgM ImmunoBlot Kit
K242872
Id-Fish Technology, Inc.
Microbiology · 262d
Cleared Aug 12, 2024
iDart Lyme IgG ImmunoBlot Kit
K233367
Id-Fish Technology, Inc.
Microbiology · 315d
Cleared Jul 13, 2023
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System
K230863
Zeus Scientific
Microbiology · 106d
Cleared Aug 19, 2022
Viramed Borrela All-In-One ViraChip Test Kit
K220016
Viramed Biotech AG
Microbiology · 226d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
K203289
Gold Standard Diagnostics
Microbiology · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
K203292
Gold Standard Diagnostics
Microbiology · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
K203295
Gold Standard Diagnostics
Microbiology · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
K203296
Gold Standard Diagnostics
Microbiology · 133d
Cleared Feb 18, 2021
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
K202573
DiaSorin, Inc.
Microbiology · 167d
Cleared Feb 18, 2021
LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
K202574
DiaSorin, Inc.
Microbiology · 167d
Cleared Apr 06, 2020
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
K200023
Gold Standard Diagnostics
Microbiology · 91d
Cleared Apr 06, 2020
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
K200025
Gold Standard Diagnostics
Microbiology · 91d
Cleared Jan 29, 2020
LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
K193051
DiaSorin, Inc.
Microbiology · 89d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K190907
Zeus Scientific, Inc.
Microbiology · 112d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K191240
Zeus Scientific, Inc.
Microbiology · 82d
Cleared Jul 29, 2019
ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K191398
Zeus Scientific, Inc.
Microbiology · 66d
Cleared Mar 12, 2019
BioPlex 2200 Lyme Total
K183446
Bio-Rad Laboratories
Microbiology · 90d
Cleared Aug 30, 2018
Sofia 2 Lyme FIA, Sofia Lyme Control Set
K173496
Quidel Corporation
Microbiology · 290d
Cleared May 02, 2018
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
K180264
Gold Standard Diagnostics
Microbiology · 92d
Cleared Feb 28, 2018
Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
K173691
Quidel Corporation
Microbiology · 89d
Cleared Dec 10, 2017
Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
K172722
Euroimmun Us, Inc.
Microbiology · 90d
Cleared Oct 23, 2017
Lyme B. burgdorferi (IgM) MarStripe Test
K172254
Trinity Biotech
Microbiology · 89d

About Product Code LSR - Regulatory Context

510(k) Submission Activity

112 total 510(k) submissions under product code LSR since 1987, with 112 receiving FDA clearance (average review time: 177 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LSR Product Code

FDA review times for LSR submissions have been consistent, averaging 180 days recently vs 177 days historically.

LSR devices are reviewed by the Microbiology panel. Browse all Microbiology devices →