Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
Device Facts
| Record ID | K253567 |
|---|---|
| Device Name | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card |
| Applicant | Healgen Scientific,, LLC |
| Product Code | NGL · Clinical Toxicology |
| Decision Date | Dec 23, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
The Healgen Accurate Urine Drug Screen Dip Card is a rapid lateral flow immunoassays for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH, Norfentanyl and Tramadol 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 panels can consist of up to eighteen (18) 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 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 Healgen Accurate Home Urine Drug Test Dip Card is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs in human urine at the cutoff concentrations of table below. This is not a screening device to monitor prescription medication.
Device Story
The device is a lateral flow immunochromatographic dip card for qualitative detection of drugs of abuse in human urine. It uses competitive binding between drug in urine and drug-protein conjugate on a membrane. If drug is present above cutoff, it binds to monoclonal antibody conjugate, preventing a colored test line; absence of line indicates preliminary positive. If drug is below cutoff, antibody binds to membrane, producing a colored line (negative). Used in home or clinical settings by lay users or professionals. Output is visual (colored lines). Preliminary results require laboratory confirmation via GC-MS or LC-MS. Benefits include rapid, point-of-care screening for potential drug abuse.
Clinical Evidence
No clinical trials performed. Evidence consists of analytical performance (precision, specificity, interference) and a lay-user study. Precision studies used spiked urine samples confirmed by LC-MS/MS over 25 days. Lay-user study included 280 participants (diverse backgrounds, ages 21->50) testing blind-labeled samples at various concentrations relative to cutoffs; results showed high agreement with expected outcomes. Method comparison study compared device results to LC-MS/MS for 80 clinical samples per drug.
Technological Characteristics
Lateral flow immunochromatographic assay. Competitive binding principle using mouse monoclonal antibodies. Dip card format, ready-to-use, sealed with desiccant. Qualitative visual readout. No electronic components or software. Stable at 2-30°C for 36 months.
Indications for Use
Indicated for qualitative detection of drugs of abuse in human urine. Intended for over-the-counter (OTC) use. Not for monitoring prescription medication. Provides preliminary results; requires confirmation by GC-MS or LC-MS.
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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