Gold Standard Diagnostics: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Gold Standard Diagnostics” (first 2012, latest 2025), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 133 days. Since 2017 the median was 133 days, against 100 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 232 |
| 2013 | 0 | — |
| 2014 | 2 | 280 |
| 2015 | 1 | 273 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 92 |
| 2019 | 0 | — |
| 2020 | 2 | 91 |
| 2021 | 4 | 133 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 256 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Gold Standard Diagnostics took a median 133 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 9 | 9 |
| GMQ | Antigens, Nontreponemal, All | 2 | 2 |
| LYR | Helicobacter Pylori | 2 | 2 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 1 | 1 |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 1 | 1 |
Review panels
- Microbiology (14)
- Immunology (1)
Most recent Gold Standard Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | GMQ | 2025-10-10 | 256 |
| K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | LSR | 2021-03-22 | 133 |
| K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | LSR | 2021-03-22 | 133 |
| K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | LSR | 2021-03-22 | 133 |
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit | LSR | 2021-03-22 | 133 |
| K200025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | LSR | 2020-04-06 | 91 |
| K200023 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | LSR | 2020-04-06 | 91 |
| K180264 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | LSR | 2018-05-02 | 92 |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | GMQ | 2015-11-12 | 273 |
| K131334 | HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST | MXJ | 2014-02-28 | 295 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gold Standard Diagnostics.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Gold Standard Orthopaedics, LLC (4 510(k)s)
- Gold Coast Imaging, Inc. (2 510(k)s)
- Gold Standard Orthopedics, LLC (2 510(k)s)
- Gold, Inc. (1 510(k)s)
- Gold Cadillac Co. (1 510(k)s)
- Gold Link Design , Ltd. (1 510(k)s)
- Gold'N Braces, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gold Standard Diagnostics?
FDA lists 15 510(k) clearances under the applicant name “Gold Standard Diagnostics” (first 2012, latest 2025), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gold Standard Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gold Standard Diagnostics is 133 days. Since 2017: 133 days, versus 100 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Gold Standard Diagnostics?
The most frequent FDA product codes under this applicant name are LSR (Reagent, Borrelia Serological Reagent, 9); GMQ (Antigens, Nontreponemal, All, 2); LYR (Helicobacter Pylori, 2).
Next steps
- See all 15 Gold Standard Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code LSR, Gold Standard Diagnostics's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.