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

K151441 · W.H.P.M., Inc. · DJR · Jun 29, 2015 · Clinical Toxicology

Device Facts

• Record ID: K151441
• 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: DJR · Clinical Toxicology
• Decision Date: Jun 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Indications for Use

First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Methadone, Phencyclidine, and Oxycodone in human urine at cut-off concentrations of 300 ng/mL, 25 ng/mL, and 100 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 drugs Methadone and Oxycodone are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There are no uniformly recognized cutoff concentration levels for Methadone and Oxycodone 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 Methadone, Phencyclidine, and Oxycodone in human urine. Device formats include single-use Cups or Dip Cards. Principle of operation: competitive binding immunoassay; urine sample migrates via capillary action; drug in sample competes with immobilized drug-conjugate for limited antibody-coated particle binding sites. Absence of colored test line indicates drug concentration above cutoff; presence of line indicates concentration below cutoff. Control line confirms proper flow. Used in point-of-care or home settings by lay users or professionals. Results are visually interpreted by the user. Preliminary positive results require confirmation via Gas Chromatography/Mass Spectrometry (GC/MS). Device aids in identifying potential drug presence to inform clinical or personal decision-making.

Clinical Evidence

Bench testing only. Precision, interference, specificity, and method comparison studies performed. Method comparison against GC/MS using 80 clinical samples per drug/format showed high concordance. Lay-user study (n=280 per drug) confirmed ease of use and performance across diverse demographics (ages 21 to >50). No clinical studies required.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Materials: Test device, desiccant, aluminum pouch, urine cup. Form factor: Cup or Dip Card. Operating temperature: 4-30°C. No electronic components; non-networked. Qualitative visual readout.

Indications for Use

Indicated for qualitative detection of Methadone, Phencyclidine, and Oxycodone in human urine for OTC and prescription use. Intended for preliminary screening; not for distinguishing between prescription use and abuse. Confirmatory testing required.

Regulatory Classification

Identification

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Special Controls

*Classification.* Class II (special controls). A methadone 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)

{0}

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

510(k) #: k151441

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.