Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair
FDA 510(k) K201326 · Psychemedics Corporation
510(k) numberK201326
Submission
- Device name
- Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair
- Applicant
- Psychemedics Corporation
Culver City, CA, US - Received
- May 19, 2020
- Decision date
- July 27, 2021
- 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
Other 510(k)s with product code DJG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual TestDJG · Traditional | Medtox Diagnostics, Inc. | 01/29/2026SE |
| 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 |
| K252520 | SEFRIA Hydrocodone Oral FluidDJG · Traditional | Immunalysis Corporation | 09/11/2025SE |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…DJG · Traditional | Healgen Scientific,, LLC | 08/15/2025SE |
| 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 |
|---|---|---|
| K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairLCM · Traditional | 04/18/2022SE |
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairLAF · Traditional | 12/15/2021SE |
| K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairJXO · Traditional | 06/25/2021SE |
| K192517 | Psychemedics Microplate EIA for Cotinine in HairMKU · Traditional | 04/22/2020SE |
| K182103 | Psychemedics Microplate EIA for Fentanyl in HairDJG · Traditional | 04/18/2019SE |
| K163590 | Psychemedics Microplate EIA for Benzodiazepines in HairJXM · Traditional | 09/15/2017SE |
| K130811 | Psychemedics Microplate Eia for AmphetamineDKZ · Traditional | 05/02/2013SE |
| K123799 | Psychemedics Microplate Eia for Oxycodone in HairDJG · Traditional | 02/08/2013SE |
| K111929 | Psychemedics Cannabinoids EiaLDJ · Traditional | 05/01/2012SE |
| K111928 | Psychemedics Phencyclidine EiaLCM · Traditional | 05/01/2012SE |
Questions and answers
When was Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair cleared by the FDA?
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair (K201326) received a 510(k) decision of Substantially Equivalent on July 27, 2021, 434 days after the submission was received.
What is the product code of K201326?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.