NGL · Test, Opiates, Over The Counter
Clinical Toxicology · 21 CFR 862.3650 · Class 2
Overview
| Product Code | NGL |
|---|---|
| Device Name | Test, Opiates, Over The Counter |
| 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 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Healgen Scientific,, LLC | Dec 23, 2025 | SESE |
| K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | Anhui Deepblue Medical Technological Co., Ltd. | Apr 15, 2025 | SESE |
| K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | Guangzhou Decheng Biotechnology Co., Ltd. | Feb 20, 2025 | SESE |
| K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus | Guangzhou Decheng Biotechnology Co., Ltd. | Feb 6, 2025 | SESE |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | Healgen Scientific,, LLC | Dec 17, 2024 | SESE |
| K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test | Eterbio, Inc. | Nov 20, 2024 | SESE |
| K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | Hangzhou Clongene Biotech Co., Ltd. | Nov 8, 2024 | SESE |
| K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | Oct 4, 2024 | SESE |
| K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel | Qingdao Hightop Biotech Co., Ltd. | Aug 14, 2024 | SESE |
| K241741 | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel | Guangzhou Wondfo Biotech Co., Ltd. | Jul 16, 2024 | SESE |
| K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. | May 22, 2024 | SESE |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) | Healgen Scientific,, LLC | May 13, 2024 | SESE |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Healgen Scientific,, LLC | Apr 12, 2024 | SESE |
| K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | Safecare Biotech (Hangzhou) Co., Ltd. | Apr 10, 2024 | SESE |
| K240295 | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) | Instanosis, Inc. | Mar 28, 2024 | SESE |
| K234006 | AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test | Allsource Screening Solutions | Mar 21, 2024 | SESE |
| K240351 | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) | Assure Tech., LLC | Mar 6, 2024 | SESE |
| K233417 | AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | Oct 26, 2023 | SESE |
| K193480 | BIOEASY Multi-Drug Test Cup | Shenzhen Bioeasy Biotechnology Co., Ltd. | Jan 31, 2020 | SESE |
| K190412 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | Hangzhou Clongene Biotech Co., Ltd. | Mar 21, 2019 | SESE |
Top Applicants
- Healgen Scientific,, LLC — 4 clearances
- Hangzhou Clongene Biotech Co., Ltd. — 3 clearances
- Amedica Biotech, Inc. — 2 clearances
- Guangzhou Decheng Biotechnology Co., Ltd. — 2 clearances
- Allsource Screening Solutions — 1 clearance
