Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup

K243365 · Healgen Scientific,, LLC · NGL · Dec 17, 2024 · Clinical Toxicology

Device Facts

• Record ID: K243365
• Device Name: Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
• Applicant: Healgen Scientific,, LLC
• Product Code: NGL · Clinical Toxicology
• Decision Date: Dec 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The Healgen® Accurate Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, Norfentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Mortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH 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 cups 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 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 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 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.

Device Story

Lateral flow immunochromatographic assay; detects drugs of abuse in human urine. Device format: cup with integrated test strips. Principle: competitive binding; drug in urine competes with drug-protein conjugate for limited monoclonal antibody binding sites. Negative result: colored line in Test Region (T) (drug below cutoff). Positive result: absence of colored line in Test Region (T) (drug at/above cutoff). Control line (C) confirms proper procedure. Used in clinical or home settings; operated by clinicians or lay users. Provides preliminary results; requires confirmatory testing (GC-MS/LC-MS) for clinical decision-making. Benefits: rapid, qualitative screening for drug presence.

Clinical Evidence

Bench testing only. Precision/reproducibility studies performed over 25 days. Analytical specificity/interference testing evaluated cross-reactivity and potential interfering substances. Method comparison study against LC-MS/MS using 80 clinical samples per drug. Lay-person study with 280 participants confirmed ease of use and performance across diverse demographics.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Materials: chromatographic absorbent device, mouse monoclonal antibody conjugates. Form factor: cup. Stability: 36 months at 2-30°C. No electronic components or software algorithms.

Indications for Use

Indicated for qualitative detection of drugs of abuse (18 analytes including amphetamines, opioids, cocaine, etc.) in human urine. Intended for prescription or over-the-counter use to provide preliminary screening results. Requires confirmatory testing via 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).

Submission Summary (Full Text)

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

510(k) Number: K243365

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.