# K242498: Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC

- Pathway: 510(k) (Traditional)
- Applicant: Aicheck Biotech, Inc.
- Decided: Oct 1, 2024 after 40 days
- Product code: NFT (Test, Amphetamine, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K945610 (1995). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202567: Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx, Guangzhou Wondfo Biotech Co., Ltd. (2020) Summary page 6.

## Indications for use
Pocguide Multi-Drug Test Panel OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, 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: Drug ( Identifier) Cut-off level Amphetamine (AMP) 1000 ng/mL or 500 ng/mL Buprenorphine (BUP) 10 ng/mL Secobarbital (BAR) 300 ng/mL Oxazepam (BZO) 300 ng/mL Benzoylecognine (COC) 300 ng/mL or 150 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL Methamphetamine (MET) 1000 ng/mL or 500 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Morphine (OPI2000/MOP300) 2000 ng/mL or 300 ng/mL Methadone (MTD) 300 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL Nortriptyline (TCA) 1000 ng/mL Marijuana (THC) 50 ng/mL 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 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 over-the-counter use. For in vitro diagnostic use only 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-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: Drug ( Identifier) Cut-off level Amphetamine (AMP) 1000 ng/mL or 500 ng/mL Buprenorphine (BUP) 10 ng/mL Secobarbital (BAR) 300 ng/mL Oxazepam (BZO) 300 ng/mL Benzoylecognine (COC) 300 ng/mL or 150 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL Methamphetamine (MET) 1000 ng/mL or 500 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Morphine (OPI2000/MOP300) 2000 ng/mL or 300 ng/mL Methadone (MTD) 300 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL Nortriptyline (TCA) 1000 ng/mL Marijuana (THC) 50 ng/mL 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

Source page: https://510kreport.com/device/K242498
Methodology: https://510kreport.com/methodology