PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup

K242077 · Aicheck Biotech, Inc. · NFT · Aug 14, 2024 · Clinical Toxicology

Device Facts

• Record ID: K242077
• Device Name: PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
• Applicant: Aicheck Biotech, Inc.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Aug 14, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

Pocguide™ Multi-Drug Test Cup OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. The single or multi-test cups can consist of up to the above listed analytes in any combination. For over-the-counter use. 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. Pocguide™ Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. The single or multi-test cups 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.

Device Story

Pocguide™ Multi-Drug Test Cup is a lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine. Device consists of a cup format containing test strips; user immerses the absorbent end into a urine sample. Principle of operation: competitive binding; drug in sample competes with drug-protein conjugate for limited antibody-dye binding sites. If drug is present at or above cutoff, it binds to antibody-dye, preventing binding to the test region (T), resulting in no colored line (positive). If drug is absent or below cutoff, antibody-dye binds to the test region, producing a colored line (negative). A control line (C) confirms proper wicking. Used in OTC or clinical settings; operated by lay users or professionals. Results are visual; preliminary only. Confirmatory testing (GC-MS/LC-MS) required for positive results. Benefits include rapid, simultaneous screening for multiple analytes to assist in identifying potential drug presence.

Clinical Evidence

Bench testing only. Performance validated via precision/reproducibility studies (25 days, 3 lots), analytical specificity/cross-reactivity, and interference testing (pH 4-9, specific gravity 1.000-1.035). Method comparison study performed with 80 clinical samples per drug against LC-MS/MS. Lay-person study (n=280) conducted at three sites confirmed ease of use and performance across diverse demographics.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Form factor: test cup. Materials: membrane pre-coated with drug-protein, antibody-dye conjugate. Connectivity: none (standalone). Sterilization: not stated. Software: none.

Indications for Use

Indicated for qualitative, simultaneous detection of Amphetamine, Buprenorphine, Butalbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, and Marijuana in human urine. Intended for OTC and professional use as a preliminary screening tool. 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 SUMMARY

510(k) Number: K242077

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.