ARK Tramadol Assay
FDA 510(k) K182280 · Ark Diagnostics, Inc.
510(k) numberK182280
Submission
- Device name
- ARK Tramadol Assay
- Applicant
- Ark Diagnostics, Inc.
Fremont, CA, US - Received
- August 22, 2018
- Decision date
- December 10, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
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| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | Randox Laboratories Limited | 01/23/2026SE |
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 01/16/2026SE |
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| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | Lin-Zhi International, Inc. | 06/18/2025SE |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA ReaderDJG · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/14/2024SE |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 05/10/2024SE |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | Co-Innovation Biotech Co., Ltd. | 03/08/2024SE |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…DJG · Traditional | Shanghai Accurature Diagnostics Co., Ltd. | 02/23/2024SE |
More from Shanghai Accurature Diagnostics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K232522 | ARK Levetiracetam II AssayORI · Traditional | 02/27/2024SE |
| K232017 | ARK Methotrexate II AssayLAO · Traditional | 12/20/2023SE |
| K231752 | ARK Hydrocodone AssayDJG · Traditional | 11/09/2023SE |
| K201089 | ARK Lacosamide AssayNWM · Traditional | 08/05/2021SE |
| K200197 | ARK Fentanyl II AssayDJG · Traditional | 02/26/2020SE |
| K182779 | ARK EDDP AssayDJR · Traditional | 11/21/2018SE |
| K180427 | ARK Fentanyl AssayDJG · Traditional | 06/06/2018SE |
| K163359 | ARK Methotrexate AssayLAO · Special | 08/18/2017SE |
| K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK…POX · Traditional | 08/09/2016SE |
| K111904 | Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark…LAO · Traditional | 10/18/2011SE |
Questions and answers
When was ARK Tramadol Assay cleared by the FDA?
ARK Tramadol Assay (K182280) received a 510(k) decision of Substantially Equivalent on December 10, 2018, 110 days after the submission was received.
What is the product code of K182280?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.