Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)

K152269 · Healgen Scientific,, LLC · DKZ · Sep 9, 2015 · Clinical Toxicology

Device Facts

• Record ID: K152269
• Device Name: Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)
• Applicant: Healgen Scientific,, LLC
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Sep 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

Healgen Amphetamine Test is an immunochromatographic assay for the qualitative determination of Amphetamine in human urine at a Cut-Off concentration of 500 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use. Healgen Cocaine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 150 ng/mL. The test is available in a Strip format, a Dip Card format and a Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use. Healgen Methamphetamine Test is an immunochromatographic assay for the qualitative determination of Methamphetamine in human urine at a Cut-Off concentration of 500 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for prescription and for over-the-counter use.

Device Story

Lateral flow immunochromatographic assays for qualitative detection of drugs of abuse (Amphetamine, Benzoylecgonine, Methamphetamine) in human urine. Input: urine specimen; capillary action moves specimen across test strip. Principle: competitive binding; target drug in urine competes with immobilized drug-conjugate for limited antibody-coated particle binding sites. Output: visual colored line in test region indicates negative result (drug below cut-off); absence of line indicates positive result (drug above cut-off). Control line confirms proper test performance. Used in point-of-care or home settings by lay users or clinicians. Results provide preliminary screening; require GC/MS confirmation for clinical decision-making. Benefits: rapid, accessible drug screening.

Clinical Evidence

No clinical studies performed. Evidence consists of bench testing (precision, cut-off verification, interference, specificity) and a lay-user study. Lay-user study included 560 participants per drug type (1680 total) across three sites, comparing device results to GC/MS. Results showed high concordance with GC/MS across all formats and concentrations.

Technological Characteristics

Lateral flow chromatographic immunoassay. Components: test device (strip, cassette, cup, or dip card) and package insert. Detection principle: competitive binding using monoclonal mouse antibodies. No energy source required. Storage: 4-30°C. No software or electronic components.

Indications for Use

Indicated for qualitative detection of Amphetamine (500 ng/mL), Benzoylecgonine (150 ng/mL), and Methamphetamine (500 ng/mL) in human urine. Intended for prescription and over-the-counter use as a preliminary screening tool. Not for definitive diagnosis; requires GC/MS confirmation.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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) #: k152269

This 510(k) was reviewed under 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.