First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test.

K152551 · W.H.P.M., Inc. · DJG · Nov 9, 2015 · Clinical Toxicology

Device Facts

• Record ID: K152551
• Device Name: First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test.
• Applicant: W.H.P.M., Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Nov 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

First Sign® Drug of Abuse Buprenorphine Cup Test First Sign® Drug of Abuse Buprenorphine Dip Card Test First Sign® Drug of Abuse Buprenorphine Tests are immunochromatographic assays for the qualitative determination of Buprenorphine, in human urine at cut-off concentration of 10 ng/mL. The tests are available in a Cup format and a Din Card format. The tests may yield preliminary positive results even when prescription drug Buprenorphine is ingescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Buprenorphine in urine. The tests provide only preliminary test results. A more specific alternative chemical method 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. First Sign® Drug of Abuse Butalbital Cup Test First Sign® Drug of Abuse Butalbital Dip Card Test First Sign® Drug of Abuse Butalbital Tests are immunochromatographic assays for the qualitative determination of Butalbital in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cup format and a Dip Card format. The tests may yield preliminary positive results even when prescription drug Butalbital 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 Butalbital in urine. The tests provide only preliminary test results. A more specific alternative chemical method 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. First Sign® Drug of Abuse Morphine Cup Test First Sign® Drug of Abuse Morphine Dip Card Test First Sign® Drug of Abuse Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 300 ng/mL. 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. 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

Lateral flow immunochromatographic assays for qualitative detection of Buprenorphine, Butalbital, or Morphine in human urine; available in cup or dip card formats. Principle: competitive binding; target drug in urine competes with drug-conjugate for limited antibody binding sites on particles. Absence of colored line at test region indicates presence of drug above cut-off; presence of line indicates drug below cut-off. Control line confirms proper flow. Used in point-of-care or home settings by lay users or professionals. Provides preliminary results; requires confirmation by GC/MS. Results assist clinical decision-making regarding drug use status.

Clinical Evidence

Bench testing only. Precision, cut-off verification, interference, and specificity studies performed. Method comparison against GC/MS conducted with 80 clinical samples per test. Lay-user study with 280 participants per test demonstrated high accuracy (95-100%) across various drug concentrations relative to GC/MS. No clinical studies required.

Technological Characteristics

Lateral flow chromatographic immunoassay; competitive binding principle. Monoclonal mouse antibodies. Formats: Cup or Dip Card. Stability: 24 months at 39-86°F. No electronic components or software algorithms.

Indications for Use

Indicated for qualitative detection of Buprenorphine (10 ng/mL), Butalbital (300 ng/mL), or Morphine (300 ng/mL) in human urine. Intended for over-the-counter and prescription use. Not intended to distinguish between prescription use and abuse.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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) #: k152251

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.