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

K142353 · W.H.P.M., Inc. · DIO · Oct 7, 2014 · Clinical Toxicology

Device Facts

• Record ID: K142353
• 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: DIO · Clinical Toxicology
• Decision Date: Oct 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Indications for Use

First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Amphetamine (d-amphetamine), Cocaine (Benzoylecgonine), and Marijuana (11-nor-A9-THC-9-COOH ) in human urine at cut-off concentrations of 1000 ng/mL, and 50 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format. The tests provide 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 iudgment should be exercised with any drug of abuse test result, particularly when the preliminary result is possive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

Device Story

Lateral flow immunochromatographic assay; detects Amphetamine, Cocaine, and Marijuana in human urine. Input: urine sample; Principle: competitive binding; target drugs compete with drug-conjugate for limited antibody binding sites. Output: visual colored line indicates negative result (drug below cut-off) or absence of line indicates positive result (drug above cut-off). Used in home or clinical settings; operated by lay users or healthcare professionals. Provides preliminary results; requires GC/MS confirmation. Benefits: rapid, qualitative screening for drug presence.

Clinical Evidence

Bench testing only. Precision studies (n=25 days, 2 runs/day) confirmed cut-off performance. Interference and specificity studies evaluated cross-reactivity with numerous compounds. Method comparison study (n=80 samples per drug) compared device results to GC/MS. Lay-user study (n=280 per drug) confirmed ease of use and performance across diverse demographics (ages 21 to >50).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Monoclonal mouse antibody-coated particles. Formats: Cup and Dip Card. Single-use. Stable at 4-30°C. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Amphetamine, Cocaine, and Marijuana in human urine. Intended for over-the-counter and prescription use by adults (age 21+).

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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) #: k142353

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.