Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
Device Facts
| Record ID | K250803 |
|---|---|
| Device Name | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup |
| Applicant | Anhui Deepblue Medical Technological Co., Ltd. |
| Product Code | NGL · Clinical Toxicology |
| Decision Date | Apr 15, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
The Deepblue Multi-Drug Urine Test Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, fentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: [Table omitted for brevity]. The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT). The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. The Deepblue Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs. [Table omitted for brevity]. This drug test cup may contain any combination of the drug tests listed in the table above. This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Device Story
Device is a rapid lateral flow immunochromatographic cup for qualitative detection of drugs of abuse in human urine. User collects urine in cup; device uses competitive binding principle where drug in sample competes with drug-protein conjugate for limited antibody binding sites. Absence of colored test line indicates preliminary positive result; presence of line indicates negative result. Control line confirms proper performance. Used in clinical or home settings by professionals or lay users. Provides preliminary screening results; requires confirmation by GC-MS or LC-MS. Benefits include rapid, on-site detection of drug presence to guide further clinical or diagnostic decision-making.
Clinical Evidence
Bench testing only. Includes precision/reproducibility studies (25 days, 3 lots), analytical specificity/interference testing, and method comparison against LC-MS/MS (80 samples per drug). Lay-user study conducted with 280 participants across 3 sites, confirming ease of use and performance across various concentrations. No clinical prospective/retrospective trials performed.
Technological Characteristics
Lateral flow immunochromatographic assay. Competitive binding principle using monoclonal antibody conjugates. Form factor: urine test cup. Storage: 2-30°C. No electronic components or software algorithms. Qualitative readout via visual color bands.
Indications for Use
Indicated for qualitative detection of drugs of abuse in human urine. Intended for prescription or over-the-counter (OTC) use. Patient population includes individuals requiring drug screening; no specific age or gender restrictions.
Regulatory Classification
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.
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).
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