# K232228: Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Accurature Diagnostics Co., Ltd.
- Decided: Feb 23, 2024 after 211 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)
- K153050: Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard, Co-Innovation Biotech Co., Ltd. (2016) Summary page 8.

## Indications for use
Accurature Multi-drug Urine Test Cup and Accurature Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of: Drug Abbreviation Cut-off Amphetamine AMP 1000ng/mL Secobarbital BAR 300 ng/mL Buprenorphine BUP 10 ng/mL Opzaepam BZO 300 ng/mL Cocaine COC 300 ng/mL Methylenedioxy-methamphetamine MDMA 500 ng/mL Methamphetamine MET 1000ng/mL Morphine MOR 300 ng/mL Methadone MTD 300 ng/mL Oxycodone OXY 100 ng/mL Phencyclidine PCP 25 ng/mL Marijuana THC 50 ng/mL Configuration of the Accurature Multi-drug Urine Test Cup and Accurature Urine Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam Secobarbital 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 over-the-counter use. Multi-drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of: Drug Abbreviation Cut-off Amphetamine AMP 1000ng/mL Secobarbital BAR 300 ng/mL Buprenorphine BUP 10 ng/mL Opzaepam BZO 300 ng/mL Cocaine COC 300 ng/mL Methylenedioxy-methamphetamine MDMA 500 ng/mL Methamphetamine MET 1000ng/mL Morphine MOR 300 ng/mL Methadone MTD 300 ng/mL Oxycodone OXY 100 ng/mL Phencyclidine PCP 25 ng/mL Marijuana THC 50 ng/mL Configuration of the Multi-drug Urine Test Cup and Multi-drug Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam Secobarbital 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 prescription use only.

Source page: https://510kreport.com/device/K232228
Methodology: https://510kreport.com/methodology