# K201630: AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests

- Pathway: 510(k) (Traditional)
- Applicant: Assure Tech. (Hangzhou) Co, Ltd.
- Decided: Aug 12, 2021 after 422 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: 7 generations back to K945610 (1995). 29 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181768: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests, Assure Tech. (Hangzhou) Co, Ltd. (2018) Summary page 6.
- K182123: ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card, Advin Biotech, Inc. (2019) Summary page 6.

## Most influential descendants
- K232659: Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup (2023), 6 descendants of its own
- 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

## Indications for use
AssureTech DOA Dipstick Screen Panel Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: Drug(Identifier) — Cut-off level 6-Monoacetylmorphine — 10 ng/mL Amphetamine — 500 ng/mL Oxazepam — 300 ng/mL Cocaine — 150 ng/mL Marijuana — 20 ng/mL Methamphetamine — 500 ng/mL Morphine — 300 ng/mL Oxycodone — 100 ng/mL Secobarbital — 300 ng/mL Buprenorphine — 10 ng/mL Methylenedioxy-methamphetamine — 500 ng/mL Phencyclidine — 25 ng/mL Methadone — 300 ng/mL EDDP — 300 ng/mL Nortriptyline — 1000 ng/mL d-Propoxyphene — 300 ng/mL Configuration of the AssureTech DOA Dipstick Screen Panel Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. AssureTech DOA Integrated Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: Drug(Identifier) — Cut-off level 6-Monoacetylmorphine — 10 ng/mL Amphetamine — 500 ng/mL Oxazepam — 300 ng/mL Cocaine — 150 ng/mL Marijuana — 20 ng/mL Methamphetamine — 500 ng/mL Morphine — 300 ng/mL Oxycodone — 100 ng/mL Secobarbital — 300 ng/mL Buprenorphine — 10 ng/mL Methylenedioxy-methamphetamine — 500 ng/mL Phencyclidine — 25 ng/mL Methadone — 300 ng/mL EDDP — 300 ng/mL Nortriptyline — 1000 ng/mL d-Propoxyphene — 300 ng/mL Configuration of the AssureTech DOA Integrated Cup Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K201630
Methodology: https://510kreport.com/methodology