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)

K240949 · Healgen Scientific,, LLC · NGL · May 13, 2024 · Clinical Toxicology

Device Facts

• Record ID: K240949
• Device Name: 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)
• Applicant: Healgen Scientific,, LLC
• Product Code: NGL · Clinical Toxicology
• Decision Date: May 13, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This test provides only preliminary result. A more specific alternative chemical must be used to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully. The Healgen® Accurate Fentanyl Rapid Test Strip (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This test provides only preliminary result. A more specific alternative chemical must be used to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully. The Healgen® Accurate Fentanyl Rapid Test Cassette (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This test provides only preliminary result. A more specific alternative chemical must be used to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully. The Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This test provides 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 Healgen® Accurate Rapid Fentanyl Test Strip (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This test provides 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 Healgen® Accurate Rapid Fentanyl Test Cassette (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This test provides 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.

Device Story

Lateral flow immunoassay for qualitative detection of fentanyl in human urine; 1.0 ng/mL cutoff. Input: urine specimen; Principle: competitive binding immunochromatography; Output: visual colored lines on test device (cassette, dip card, or strip). Used in point-of-care or home settings by lay users or clinicians. Absence of line at test region indicates fentanyl presence above cutoff; presence of line at control region confirms valid test. Results are preliminary; require confirmatory testing. Benefits patient by providing rapid screening for fentanyl presence.

Clinical Evidence

Bench testing only. Precision, interference, specificity, and method comparison studies performed. Method comparison against LC/MS using 80 clinical samples showed high concordance. Lay-user study (n=140 per format) demonstrated 100% correct results across various concentrations, confirming ease of use and accuracy for non-professional users.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: cassette, dip card, strip. Storage: 36-86°F. No electronic components; standalone device. Materials include test device and desiccant in aluminum pouch.

Indications for Use

Indicated for qualitative detection of fentanyl in human urine at 1.0 ng/mL cutoff. Intended for OTC and prescription use. Provides preliminary 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 MEMORANDUM

510(k) Number: K240949

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.

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