Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC

K242498 · Aicheck Biotech, Inc. · NFT · Oct 1, 2024 · Clinical Toxicology

Device Facts

• Record ID: K242498
• Device Name: Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC
• Applicant: Aicheck Biotech, Inc.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Oct 1, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

Pocguide™ Multi-Drug Test Panel is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5dimethyl-3,3-diphenylpyrrolidine, Methylenedioxy-methamphetamine, Morphine, Mothadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: [Table of analytes and cutoffs]. The single or multi-test panels can consist of up to the above listed analytes in any combination. The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. For in vitro diagnostic use only. Pocguide™ Multi-Drug Test Panel OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencycline and Marijuana in human urine at the cutoff concentrations of: [Table of analytes and cutoffs]. The single or multi-test panels can consist of up to the above listed analytes in any combination. The tests provide only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. For over-the-counter (OTC) use. For in vitro diagnostic use only.

Device Story

Lateral flow immunochromatographic dipcard assay; detects drugs of abuse in human urine. Principle: competitive binding; drug in sample competes with drug-protein conjugate for limited antibody-dye binding sites. Sample wicks via capillary action; absence of colored test line indicates positive result (drug concentration at/above cutoff); presence of colored line indicates negative result. Control line confirms proper wicking. Used in clinical/OTC settings; operator immerses absorbent end of dipcard into urine. Results read visually by user/clinician. Preliminary positive results require confirmation via GC-MS or LC-MS. Benefits: rapid, qualitative screening for multiple drugs simultaneously.

Clinical Evidence

Bench testing only. Analytical performance: precision/reproducibility (3 lots, 25 days), cross-reactivity, and interference studies. Method comparison: 100 clinical samples per drug compared to LC-MS/MS. Lay-user study: 162 participants (Configuration 1) and 140 participants (Configuration 2) demonstrated ease of use and performance across various concentrations.

Technological Characteristics

Lateral flow immunochromatographic assay; dipcard format with integrated test strips. Qualitative detection. Materials: plastic dipcard, absorbent test strips, antibody-dye conjugates. No external energy source. Standalone device. Shelf life: 24 months at 4-30°C.

Indications for Use

Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana) in human urine. Intended for both professional (Rx) and over-the-counter (OTC) use. Provides preliminary results; requires confirmatory testing (GC-MS/LC-MS). Not intended to distinguish between prescription use and abuse.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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 MEMORANDUM

510(k) Number: K242498

This 510(k) was reviewed under the OHT7/OHT8 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.