FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

K142408 · Polymed Therapeutics, Inc. · LDJ · Sep 25, 2014 · Clinical Toxicology

Device Facts

• Record ID: K142408
• Device Name: FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
• Applicant: Polymed Therapeutics, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Sep 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Indications for Use

FaStep Marijuana Tests are immunochromatographic assays for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a cut-off concentration of 50ng/mL. The test is available in a Strip format, a Panel Dip format, a Ouick Cup format and a Turn-Key Split 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. FaStep Methamphetamine Tests are immunochromatographic assays for the qualitative determination of methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The test is available in a Strip format, a Panel Dip format, a Quick Cup format and a Turn-Key Split 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

FaStep Marijuana and Methamphetamine tests are lateral flow immunochromatographic assays for qualitative drug detection in human urine. Input: urine specimen; Principle: competitive binding using monoclonal antibody-dye conjugates and immobilized drug-protein conjugates on a membrane. If drug concentration is below cut-off, antibody binding sites remain available to bind immobilized drug-conjugate, producing a visible test line. If drug concentration exceeds cut-off, binding sites are saturated, preventing test line formation. Control line confirms proper flow. Used in point-of-care or home settings by lay users or clinicians. Output: visual qualitative result (positive/negative). Results are preliminary; require GC/MS confirmation. Benefits: rapid, accessible screening for drug presence to inform clinical or personal decision-making.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical bench testing (precision, cut-off verification, interference, specificity) and a lay-user study (n=147). Precision studies across 25 days showed consistent results. Lay-user study demonstrated high accuracy (90.5%-100%) across various concentrations compared to GC/MS, with all users reporting instructions were easy to follow (Flesch-Kincaid Grade Level 7).

Technological Characteristics

Lateral flow immunochromatographic assay. Components: monoclonal antibody-dye conjugate (gold chloride), fixed drug-protein conjugates, anti-mouse IgG polyclonal antibody on membranes. Configurations: Strip, Panel Dip, Quick Cup, Turn-Key Split Cup. Stability: 18 months at 4-30°C. Standalone, non-electronic, visual read-out.

Indications for Use

Indicated for qualitative detection of 11-nor-Δ9-THC-9-COOH (50 ng/mL cut-off) or methamphetamine (1000 ng/mL cut-off) in human urine. Intended for OTC and prescription use as a preliminary screening tool. Not for definitive diagnosis; requires GC/MS confirmation.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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) #: k142408

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.