# K230238: BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Bioeasy Biotechnology Co., Ltd.
- Decided: Mar 31, 2023 after 60 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201630: AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests, Assure Tech. (Hangzhou) Co, Ltd. (2021) Summary page 8.

## Indications for use
BIOEASY™ U-Catch MAX Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Marijuana 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 (COC) — 150 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) — 300 ng/mL Methamphetamine (MET) — 500 ng/mL Methylenedioxymethamphetamine (MDMA) — 500 ng/mL Morphine (MOP 300) — 300 ng/mL Methadone (MTD) — 300 ng/mL Oxycodone (OXY) — 100 ng/mL Phencyclidine (PCP) — 25 ng/mL d-Propoxyphene (PPX) — 300 ng/mL Nortriptyline (TCA) — 1000 ng/mL Marijuana (THC) — 50 ng/mL BIOEASY™ U-Catch MAX Multi-Drug Test Cup offers any combinations 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 Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, d-Propoxyphene, and Oxycodone 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. BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline Cannabinoids and 6-Acetylmorphine 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 (COC) — 150 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) — 300 ng/mL Methamphetamine (MET) — 500 ng/mL Methylenedioxymethamphetamine (MDMA) — 500 ng/mL Morphine (MOP 300) — 300 ng/mL Methadone (MTD) — 300 ng/mL Oxycodone (OXY) — 100 ng/mL Phencyclidine (PCP) — 25 ng/mL d-Propoxyphene (PPX) — 300 ng/mL Nortriptyline (TCA) — 1000 ng/mL Cannabinoids (THC) — 50 ng/mL 6-Acetylmorphine — 10 ng/mL BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, d-Propoxyphene, and Oxycodone 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/K230238
Methodology: https://510kreport.com/methodology