Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
FDA 510(k) K203292 · Gold Standard Diagnostics
510(k) numberK203292
Submission
- Device name
- Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
- Applicant
- Gold Standard Diagnostics
Davis, CA, US - Received
- November 9, 2020
- Decision date
- March 22, 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
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| 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 |
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitLSR · Traditional | Gold Standard Diagnostics | 03/22/2021SE |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusLSR · Traditional | DiaSorin, Inc. | 02/18/2021SE |
More from DiaSorin, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | 10/10/2025SE |
| K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR · Traditional | 03/22/2021SE |
| K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional | 03/22/2021SE |
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitLSR · Traditional | 03/22/2021SE |
| K200025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR · Traditional | 04/06/2020SE |
| K200023 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional | 04/06/2020SE |
| K180264 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR · Traditional | 05/02/2018SE |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | 11/12/2015SE |
| K131334 | Herpes Simplex Virus Type 1 Igg Elisa TestMXJ · Traditional | 02/28/2014SE |
| K131330 | Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitLJM · Traditional | 01/28/2014SE |
Questions and answers
When was Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit cleared by the FDA?
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (K203292) received a 510(k) decision of Substantially Equivalent on March 22, 2021, 133 days after the submission was received.
What is the product code of K203292?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.