Atlas FDA

LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus

FDA 510(k) clearance K202573 · decided 2021-02-18

Clearance details

K-number
K202573
Device name
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
Applicant
DiaSorin, Inc.
Decision
Substantially Equivalent
Date received
2020-09-04
Decision date
2021-02-18
Days to decision
167 days
Clearance type
Traditional
Product code
LSR
Device class
2
Regulation number
866.3830
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Stillwater, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Sofia Lyme FIA; Sofia 2 Campylobacter FIA (K254295)Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)2026-07-10
Lyme-ID IgG Test; Bio-ID800 (K252627)Inanovate, Inc.2025-11-14
iDart Lyme IgM ImmunoBlot Kit (K242872)Id-Fish Technology, Inc.2025-06-12
iDart Lyme IgG ImmunoBlot Kit (K233367)Id-Fish Technology, Inc.2024-08-12
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit (K230863)Zeus Scientific2023-07-13
Viramed Borrela All-In-One ViraChip Test Kit (K220016)Viramed Biotech AG2022-08-19
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (K203295)Gold Standard Diagnostics2021-03-22
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (K203292)Gold Standard Diagnostics2021-03-22
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (K203296)Gold Standard Diagnostics2021-03-22
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit (K203289)Gold Standard Diagnostics2021-03-22
LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus (K202574)DiaSorin, Inc.2021-02-18
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (K200023)Gold Standard Diagnostics2020-04-06

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S008)DiaSorin, Inc.2025-12-19
LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (P180047/S041)DiaSorin, Inc.2025-12-19
LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (P180039/S023)DiaSorin, Inc.2025-10-10
LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S021)DiaSorin, Inc.2025-10-10
LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S007)DiaSorin, Inc.2025-10-10
LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S020)DiaSorin, Inc.2025-10-10
LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S037)DiaSorin, Inc.2025-10-10
LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S021)DiaSorin, Inc.2025-10-10