Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card

K240686 · Healgen Scientific,, LLC · NGL · Apr 12, 2024 · Clinical Toxicology

Device Facts

• Record ID: K240686
• 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: Apr 12, 2024
• 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, EDDP, d/l-Methadone, d-Methamphetamine, d1-Methylenedioxymethamine, Mortriptyline, 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 panels can consist of up to sixteen (16) 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 at the cutoff concentrations of table below. This is not a screening device to monitor prescription medication.

Device Story

Lateral flow immunochromatographic dip card for qualitative detection of drugs of abuse in human urine; competitive binding principle using monoclonal antibody-drug conjugates. User dips card into urine sample; capillary action draws sample across pre-coated membrane. Negative result: colored line appears in Test Region (T) when drug concentration is below cutoff. Positive result: no line in Test Region (T) when drug concentration is at or above cutoff. Control line (C) confirms proper test performance. Used in clinical or home settings; operated by clinicians or lay users. Provides preliminary results; requires confirmation by GC-MS or LC-MS. Benefits patient by providing rapid, preliminary screening for potential drug abuse.

Clinical Evidence

Bench testing only. Performance evaluated via 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 diverse demographics, confirming ease of use and performance agreement with LC-MS/MS.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding; mouse monoclonal antibody conjugates. Dip card format; ready-to-use; includes desiccant. Stable at 2-30°C for 24 months. No electronic components or software algorithms.

Indications for Use

Indicated for qualitative detection of drugs of abuse in human urine. Intended for both prescription and over-the-counter (OTC) use. Provides preliminary results for 16 analytes (6-MAM, AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MTD, OPI, OXY, PCP, PPX, TCA, THC). Not for monitoring prescription medication.

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).

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: K240686

This 510(k) was reviewed under the OHT7/OHT8 OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.