LSR · Class II · 21 CFR 866.3830

FDA Product Code LSR: Reagent, Borrelia Serological Reagent

Leading manufacturers include DiaSorin, Inc., Id-Fish Technology, Inc. and Inanovate, 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 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

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 Review Time

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 →