First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test

K150162 · W.H.P.M., Inc. · LAF · Feb 26, 2015 · Clinical Toxicology

Device Facts

• Record ID: K150162
• Device Name: First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
• Applicant: W.H.P.M., Inc.
• Product Code: LAF · Clinical Toxicology
• Decision Date: Feb 26, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Indications for Use

First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Oxazepam , Methamphetamine , and Morphine in human urine at cut-off concentrations of 300 ng/mL, 1000 ng/mL, and 2000 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format. The tests may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for oxazepam in urine. The tests provide only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry 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. The tests are intended for over-the-counter and for prescription use.

Device Story

First Sign™ Drug of Abuse Tests are lateral flow immunochromatographic assays for qualitative detection of Oxazepam, Methamphetamine, and Morphine in human urine. Available in Cup or Dip Card formats. Principle: competitive binding; target drugs in urine compete with drug-conjugate for limited antibody binding sites on particles. If drug concentration is below cut-off, antibody-coated particles bind to immobilized drug-conjugate, forming a visible colored line (negative result). If drug concentration exceeds cut-off, binding sites are saturated, preventing line formation (positive result). Used by lay users (OTC) or clinicians (prescription) for preliminary screening. Results are visually interpreted by the user. Positive results require confirmatory testing via GC/MS. Benefits include rapid, point-of-care screening for drug presence.

Clinical Evidence

Bench testing only. Performance validated via precision studies (25 days, 3 operators), interference testing with physiological substances, and specificity/cross-reactivity analysis. Method comparison studies (n=80 per drug) compared device results to GC/MS. A lay-user study (n=280 per drug) confirmed performance across diverse demographics and verified readability of instructions (Flesch-Kincaid Grade Level 7).

Technological Characteristics

Lateral flow immunochromatographic assay. Materials include monoclonal mouse antibodies. Form factors: Cup and Dip Card. Energy source: none (capillary action). Connectivity: none. Sterilization: not specified. Software: none.

Indications for Use

Indicated for the qualitative detection of Oxazepam, Methamphetamine, and Morphine in human urine for over-the-counter and prescription use. Not intended to distinguish between prescription use and abuse of Oxazepam. Provides preliminary results only; requires confirmation by GC/MS.

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) #: k150162

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.