Ark Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Ark Diagnostics, Inc.” (first 2009, latest 2024), plus 1 De Novo decision, across 9 product codes in 1 review panel. Median 510(k) review time under this name: 156 days. Since 2017 the median was 147 days, against 136 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 237 |
| 2017 | 1 | 261 |
| 2018 | 3 | 110 |
| 2019 | 0 | — |
| 2020 | 1 | 30 |
| 2021 | 1 | 469 |
| 2022 | 0 | — |
| 2023 | 2 | 156 |
| 2024 | 1 | 193 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ark Diagnostics, Inc. took a median 147 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 4 | 4 |
| LAO | Enzyme Immunoassay, Methotrexate | 3 | 3 |
| NWM | Immunoassay, Anti-Seizure Drug | 3 | 3 |
| ORI | Levetiracetam Assay | 2 | 2 |
| DJR | Enzyme Immunoassay, Methadone | 1 | 1 |
| ORH | Lamotrigine Assay | 1 | 1 |
| OTF | Gabapentin Assay | 1 | 1 |
| POX | Enzyme Immunoassay, Oxcarbazepine Metabolite | 1 | 1 |
| PUJ | Voriconazole Test System | 1 | 0 |
Review panels
- Clinical Toxicology (17)
Most recent Ark Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232522 | ARK Levetiracetam II Assay | ORI | 2024-02-27 | 193 |
| K232017 | ARK Methotrexate II Assay | LAO | 2023-12-20 | 166 |
| K231752 | ARK Hydrocodone Assay | DJG | 2023-11-09 | 147 |
| K201089 | ARK Lacosamide Assay | NWM | 2021-08-05 | 469 |
| K200197 | ARK Fentanyl II Assay | DJG | 2020-02-26 | 30 |
| K182280 | ARK Tramadol Assay | DJG | 2018-12-10 | 110 |
| K182779 | ARK EDDP Assay | DJR | 2018-11-21 | 51 |
| K180427 | ARK Fentanyl Assay | DJG | 2018-06-06 | 110 |
| K163359 | ARK Methotrexate Assay | LAO | 2017-08-18 | 261 |
| K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control | POX | 2016-08-09 | 237 |
6 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN160033 | De Novo | Voriconazole Test System | 2017-05-05 |
Recalls
openFDA lists no recalls under a recalling firm named Ark Diagnostics, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ark Diagnostics, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Ark Diagnostics, Inc.” (first 2009, latest 2024), plus 1 De Novo decision, across 9 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ark Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ark Diagnostics, Inc. is 156 days. Since 2017: 147 days, versus 136 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ark Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are DJG (Enzyme Immunoassay, Opiates, 4); LAO (Enzyme Immunoassay, Methotrexate, 3); NWM (Immunoassay, Anti-Seizure Drug, 3).
Next steps
- See all 16 Ark Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DJG, Ark Diagnostics, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.