# K232659: Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Decheng Biotechnology Co., Ltd.
- Decided: Dec 13, 2023 after 104 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.
6 later devices descend from it; 3 cite it directly.
0 of 37 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.

## Most influential descendants
- K240686: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (2024), 3 descendants of its own
- K253567: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (2025), 0 descendants of its own
- K250803: Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup (2025), 0 descendants of its own
- K250067: Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (2025), 0 descendants of its own
- K243365: Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup (2024), 0 descendants of its own

## Indications for use
Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table. Drug (Identifier) — Cut-off level (ng/mL) Amphetamine (AMP) — 1000 or 500 Secobarbital (BAR) — 300 Buprenorphine (BUP) — 10 Oxazepam (BZO) — 300 Cocaine (COC) — 300 or 150 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) — 300 Methylenedioxymethamphetamine (MDMA) — 500 Methamphetamine (MET) — 1000 or 500 Morphine (MOP300/OPI2000) — 2000 or 300 Methadone (MTD) — 300 Oxycodone (OXY) — 100 Phencyclidine (PCP) — 25 Propoxyphene (PPX) — 300 Nortriptyline (TCA) — 1000 Cannabinoids (THC) — 50 6-Monoacetylmorphine (6-MAM) — 10 Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device . It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method. Dochek® Multi-Drug Urine Test Cup Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table. Drug (Identifier) — Cut-off level (ng/mL) Amphetamine (AMP) — 1000 or 500 Secobarbital (BAR) — 300 Buprenorphine (BUP) — 10 Oxazepam (BZO) — 300 Cocaine (COC) — 300 or 150 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) — 300 Methylenedioxymethamphetamine (MDMA) — 500 Methamphetamine (MET) — 1000 or 500 Morphine (MOP300/OPI2000) — 2000 or 300 Methadone (MTD) — 300 Oxycodone (OXY) — 100 Phencyclidine (PCP) — 25 Propoxyphene (PPX) — 300 Nortriptyline (TCA) — 1000 Cannabinoids (THC) — 50 6-Monoacetylmorphine (6-MAM) — 10 Dochek® Multi-Drug Urine Test Cup Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device . It is intended for prescription use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.

Source page: https://510kreport.com/device/K232659
Methodology: https://510kreport.com/methodology