Lyme B. burgdorferi (IgG) MarStripe Test
FDA 510(k) K163095 · Trinity Biotech
510(k) numberK163095
Submission
- Device name
- Lyme B. burgdorferi (IgG) MarStripe Test
- Applicant
- Trinity Biotech
Buffalo, NY, US - Received
- November 4, 2016
- Decision date
- February 1, 2017
- 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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| K242872 | iDart Lyme IgM ImmunoBlot KitLSR · Traditional | Id-Fish Technology, Inc. | 06/12/2025SE |
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| 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 |
|---|---|---|
| K172254 | Lyme B. burgdorferi (IgM) MarStripe TestLSR · Traditional | 10/23/2017SE |
| K120001 | Unigold GiardiaMHI · Traditional | 03/01/2013SE |
| K121565 | Uni-Gold CryptosporidiumMHJ · Traditional | 02/08/2013SE |
| K083896 | Destiny Max Coagulation AnalyzerJPA · Traditional | 07/02/2009SE |
| K033059 | Herpes Group IggLGC · Traditional | 11/26/2003SE |
| K014233 | Captiam Syphilis-G AssayLIP · Special | 01/24/2002SE |
| K011709 | Uni-Gold Strep a Test KitGTZ · Traditional | 11/08/2001SE |
| K001525 | Captia Syphilis-G Elisa Test SystemLIP · Traditional | 11/29/2000SE |
| K991697 | Uni-Gold H. PyloriLYR · Traditional | 12/21/1999SE |
| K982373 | Uni-Gold Strep a Test KitGTY · Traditional | 02/11/1999SE |
Questions and answers
When was Lyme B. burgdorferi (IgG) MarStripe Test cleared by the FDA?
Lyme B. burgdorferi (IgG) MarStripe Test (K163095) received a 510(k) decision of Substantially Equivalent on February 1, 2017, 89 days after the submission was received.
What is the product code of K163095?
The FDA product code is LSR – Reagent, Borrelia Serological Reagent, a Class II (moderate risk) device regulated under 21 CFR 866.3830.