DJG · Enzyme Immunoassay, Opiates
Clinical Toxicology · 21 CFR 862.3650 · Class 2
Overview
| Product Code | DJG |
|---|---|
| Device Name | Enzyme Immunoassay, Opiates |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
Classification Rationale
Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Special Controls
*Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Recent Cleared Devices (20 of 215)
Showing 20 most recent of 215 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | Jan 29, 2026 | SESE |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | Jan 23, 2026 | SESE |
| K253082 | LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. | Jan 16, 2026 | SESE |
| K252520 | SEFRIA Hydrocodone Oral Fluid | Immunalysis Corporation | Sep 11, 2025 | SESE |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | Healgen Scientific,, LLC | Aug 15, 2025 | SESE |
| K251634 | LZI Fentanyl III Enzyme Immunoassay | Lin-Zhi International, Inc. | Jun 18, 2025 | SESE |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | Jun 14, 2024 | SESE |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard | Guangzhou Decheng Biotechnology Co., Ltd. | May 10, 2024 | SESE |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. | Mar 8, 2024 | SESE |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card | Shanghai Accurature Diagnostics Co., Ltd. | Feb 23, 2024 | SESE |
| K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) | Hangzhou Laihe Biotech Co., Ltd. | Jan 9, 2024 | SESE |
| K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test | Chemtron Biotech, Inc. | Dec 20, 2023 | SESE |
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | Guangzhou Decheng Biotechnology Co., Ltd. | Dec 13, 2023 | SESE |
| K231752 | ARK Hydrocodone Assay | Ark Diagnostics, Inc. | Nov 9, 2023 | SESE |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | Oct 5, 2023 | SESE |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Randox Laboratories Limited | Oct 5, 2023 | SESE |
| K231007 | CEDIA Heroin Metabolite (6-AM) Assay | Microgenics Corporation | Sep 27, 2023 | SESE |
| K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. | Jul 31, 2023 | SESE |
| K221605 | Emit® II Plus Buprenorphine Assay | Siemens Healthcare Diagnostics, Inc. | Jul 25, 2023 | SESE |
| K230238 | BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx | Shenzhen Bioeasy Biotechnology Co., Ltd. | Mar 31, 2023 | SESE |
Top Applicants
- Lin-Zhi International, Inc. — 16 clearances
- Immunalysis Corporation — 11 clearances
- Guangzhou Wondfo Biotech Co., Ltd. — 8 clearances
- Syva Co. — 8 clearances
- Medtox Diagnostics, Inc. — 7 clearances
