LSR · Class II · 21 CFR 866.3830

FDA Product Code LSR: Reagent, Borrelia Serological Reagent

Leading manufacturers include Gold Standard Diagnostics, Zeus Scientific, Inc. and DiaSorin, Inc..

111
Total
111
Cleared
177d
Avg days
1987
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 221d recently vs 176d historically

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

111 devices
1–24 of 111
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 Jun 26, 2008
PLATELIA LYME IGM
K081362
Bio-Rad
Microbiology · 42d
Cleared May 08, 2008
PLATELIA LYME IGG ASSAY
K080012
Bio-Rad
Microbiology · 126d
Cleared Dec 14, 1990
3M IGG FASTLYME(TM) TEST
K895713
3M Company
Microbiology · 445d

About Product Code LSR - Regulatory Context

510(k) Submission Activity

111 total 510(k) submissions under product code LSR since 1987, with 111 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

Recent submissions under LSR have taken an average of 221 days to reach a decision - up from 176 days historically. Manufacturers should account for longer review timelines in current project planning.

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