# K242540: AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AllTest Biotech Co., Ltd.
- Decided: Sep 27, 2024 after 32 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: 10 generations back to K001178 (2000). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241428: AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup, Hangzhou AllTest Biotech Co., Ltd. (2024) Summary page 6.

## Indications for use
AllTest Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of: Drug (Identifier) Cut-off level Amphetamine (AMP) 500 ng/mL Buprenorphine (BUP) 10 ng/mL Secobarbital (BAR) 300 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COCQ) 150 ng/mL Methamphetamine (MET) 500 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Morphine (MOP/OPI) 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 Fentanyl(FYL) 1 ng/mL AllTest Multi-Drug Urine Test Panel can be a single drug test panel or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. 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 preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. AllTest Multi-Drug Rapid Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of: Drug (Identifier) Calibrator Cut-off (hg/mL) Amphetamine (AMP) d-Amphetamine 500 Buprenorphine (BUP) Buprenorphine 10 Secobarbital (BAR) Secobarbital 300 Oxazepam (BZO) Oxazepam 300 Cocaine (COC) Benzoylecgonine 150 Methamphetamine (MET) d-Methamphetamine 500 Methylenedioxymethamphetamine (MDMA) d,I-Methylenedioxymethamphetamine 500 Morphine (MOP/OPI) Morphine 300 Methadone (MTD) Methadone 300 Oxycodone (OXY) Oxycodone 100 Phencyclidine (PCP) Phencyclidine 25 Nortriptyline (TCA) Nortriptyline 1000 Marijuana (THC) 11-nor-A9-THC-9 COOH 50 Fentanyl(FYL) Fentanyl 1 AllTest Multi-Drug Rapid Urine Test Panel can be a single drug test panel or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. 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 preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Source page: https://510kreport.com/device/K242540
Methodology: https://510kreport.com/methodology