HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)

K141647 · Healgen Scientific,, LLC · DIO · Jul 17, 2014 · Clinical Toxicology

Device Facts

• Record ID: K141647
• Device Name: HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
• Applicant: Healgen Scientific,, LLC
• Product Code: DIO · Clinical Toxicology
• Decision Date: Jul 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Indications for Use

Healgen COC One Step Cocaine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 300 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 over-the-counter and for prescription use. Healgen MOP One Step Morphine Test is an immunochromatographic assay for the qualitative determination of morphine in human urine at a Cut-Off concentration of 300 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 over-the-counter and for prescription use.

Device Story

Lateral flow immunochromatographic assay for qualitative detection of Benzoylecgonine or morphine in human urine. Input: urine sample; process: competitive binding immunoassay where target drug competes with drug-conjugate for limited antibody binding sites; output: visual colored line (negative) or absence of line (positive) in test region. Used in point-of-care or home settings by lay users or clinicians. Provides preliminary screening results; positive results require confirmatory testing via GC/MS. Assists in clinical decision-making regarding drug abuse status.

Clinical Evidence

No clinical studies performed. Evidence based on bench testing: precision studies (25 days, 2 runs/day), analytical specificity/cross-reactivity, interference testing, and method comparison against GC/MS (80 samples per format). Lay-user study (n=140 per drug) confirmed ease of use and performance across diverse demographics (ages 21 to >50).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: Strip, Cassette, Dip Card, Cup. Single-use. Visual read. Stable at 4-30°C for 24 months. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Benzoylecgonine (cocaine metabolite) or morphine in human urine at 300 ng/mL cut-off. Intended for OTC and prescription use in adults and adolescents. Provides preliminary results; requires confirmatory testing (GC/MS).

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)

{0}

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

510(k) #: k141647

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.