LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
FDA 510(k) K202573 · DiaSorin, Inc.
510(k) numberK202573
Submission
- Device name
- LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
- Applicant
- DiaSorin, Inc.
Stillwater, MN, US - Received
- September 4, 2020
- Decision date
- February 18, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LSR – Reagent, Borrelia Serological Reagent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3830
- Specialty
- Microbiology
Other 510(k)s with product code LSR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254295 | Sofia Lyme FIA; Sofia 2 Campylobacter FIALSR · Traditional | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 07/10/2026SE |
| K252627 | Lyme-ID IgG Test; Bio-ID800LSR · Traditional | Inanovate, Inc. | 11/14/2025SE |
| K242872 | iDart Lyme IgM ImmunoBlot KitLSR · Traditional | Id-Fish Technology, Inc. | 06/12/2025SE |
| K233367 | iDart Lyme IgG ImmunoBlot KitLSR · Traditional | Id-Fish Technology, Inc. | 08/12/2024SE |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia…LSR · Traditional | Zeus Scientific | 07/13/2023SE |
| K220016 | Viramed Borrela All-In-One ViraChip Test KitLSR · Traditional | Viramed Biotech AG | 08/19/2022SE |
| K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
More from Gold Standard Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXLOM · Traditional | 06/04/2026SE |
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HTLFY · Traditional | 10/27/2023SE |
| K223403 | LIAISON Anti-HAV; LIAISON XSLOL · Special | 12/09/2022SE |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusNXO · Traditional | 07/26/2022SE |
| K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control SetQPS · Traditional | 07/14/2022SE |
| K193650 | LIAISON FerritinDBF · Traditional | 09/14/2021SE |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusLSR · Traditional | 02/18/2021SE |
| K210272 | LIAISON Anti-HAVLOL · Special | 02/09/2021SE |
| K201908 | LIAISON Testosterone xtCDZ · Special | 10/15/2020SE |
| K192586 | LIAISON® FolateCGN · Traditional | 05/06/2020SE |
Questions and answers
When was LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus cleared by the FDA?
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (K202573) received a 510(k) decision of Substantially Equivalent on February 18, 2021, 167 days after the submission was received.
What is the product code of K202573?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.