Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)

K150096 · Healgen Scientific,, LLC · LAF · Mar 4, 2015 · Clinical Toxicology

Device Facts

• Record ID: K150096
• Device Name: Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
• Applicant: Healgen Scientific,, LLC
• Product Code: LAF · Clinical Toxicology
• Decision Date: Mar 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Indications for Use

Healgen MDMA (Ecstasy) Test is an immunochromatographic assay for the qualitative determination of Methylenedioxymethamphetamine 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. Healgen Phencyclidine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a Cut-Off concentration of 25 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 MDMA or Phencyclidine in human urine; competitive binding principle using monoclonal mouse antibodies; visual colored line output indicates presence/absence of drug relative to cut-off; used in point-of-care or home settings by lay users or clinicians; provides preliminary results requiring GC/MS confirmation; aids in drug abuse screening; results interpreted visually by user.

Clinical Evidence

Bench testing included precision, interference, specificity, and cut-off verification. Method comparison study (n=80 per format) compared device results to GC/MS. Lay-user study (n=1112) evaluated performance across diverse demographics; results showed high concordance with GC/MS at concentrations near cut-off. No clinical studies required.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding; monoclonal mouse antibody; formats: strip, cassette, dip card, cup; storage 4-30°C; shelf life 24 months; no electronic components; no software.

Indications for Use

Indicated for qualitative detection of MDMA (500 ng/mL) or Phencyclidine (25 ng/mL) in human urine. Intended for prescription and over-the-counter use by adults for preliminary drug screening.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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) #: k150096

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.