# Gold Standard Diagnostics

- Location (FDA's records): Davis, CA
- FDA decisions: 15 (2012–2025): 15 510(k) clearances
- Names in FDA's records: Gold Standard Diagnostics (14); Gold Standard Diagnostics, LLC (1)
- Product codes: LSR (9), GMQ (2), LYR (2), LJM (1), MXJ (1)
- 510(k) review time since 2016: median 133 days, against 133 for FDA's reviews in the same codes and years (0 of 7 faster)
- Predicates its devices cite: 18 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mardx Diagnostics, Inc.: 6 (https://510kreport.com/company/mardx-diagnostics)
- Trinity Biotech USA: 2 (https://510kreport.com/company/trinity-biotech-usa)
- Micro Detect, Inc.: 2 (https://510kreport.com/company/micro-detect)
- Aesku, Inc.: 1 (https://510kreport.com/company/aesku)
- Mrl Diagnostics: 1 (https://510kreport.com/company/mrl-diagnostics)
- Arlington Scientific, Inc.: 1 (https://510kreport.com/company/arlington-scientific)

## Its most-cited devices
- K113846: Borrelia Burgdorferi Igm Blot Test (2012), cited by 2
- K113847: Borrelia Burgdorferi Igg Blot Test (2012), cited by 2
- K150358: Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (2015), cited by 1

## Recent decisions
- K250249: Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (Oct 10, 2025)
- K203292: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (Mar 22, 2021)
- K203296: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (Mar 22, 2021)
- K203295: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (Mar 22, 2021)
- K203289: Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit (Mar 22, 2021)
- K200025: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit (Apr 6, 2020)
- K200023: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit (Apr 6, 2020)
- K180264: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit (May 2, 2018)

Source page: https://510kreport.com/company/gold-standard-diagnostics