Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test System
FDA 510(k) K100023 · Medtox Diagnostics, Inc.
510(k) numberK100023
Submission
- Device name
- Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test System
- Applicant
- Medtox Diagnostics, Inc.
Burlington, NC, US - Received
- January 5, 2010
- Decision date
- April 5, 2010
- 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 |
|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual TestDJG · Traditional | 01/29/2026SE |
| K100951 | Medtox Buprenorphine TestDJG · Traditional | 10/18/2010SE |
| K091454 | Profile-V Medtoxscan Drugs of Abuse Test SystemDJG · Traditional | 07/24/2009SE |
| K080635 | MedtoxscanDKZ · Traditional | 02/13/2009SE |
| K060351 | Medtox OxycodoneDJG · Traditional | 05/12/2006SE |
| K050394 | Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone…DKZ · Traditional | 10/25/2005SE |
| K033334 | Profile -ErDIS · Special | 11/10/2003SE |
| K031032 | Verdict II, Profile IIDJG · Special | 07/14/2003SE |
| K022141 | Verdict-IiDJC · Special | 07/30/2002SE |
| K020787 | Verdict-Ii PropoxypheneJXN · Traditional | 05/02/2002SE |
Questions and answers
When was Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test System cleared by the FDA?
Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test System (K100023) received a 510(k) decision of Substantially Equivalent on April 5, 2010, 90 days after the submission was received.
What is the product code of K100023?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.