# K082977: Bionexia Opticup Multi-Strip Doa Dipstick Test Integrated Cup

- Pathway: 510(k) (Special)
- Applicant: Mk Bio, Inc.
- Decided: Aug 20, 2009 after 318 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945610 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061005: Accustep Doa Single and Multi-Strip Screen Panels, Applied Dna Technologies, Inc. (2006) Summary page 3.

## Indications for use
The Bionexia OptiCup is a rapid chromatographic immuneassay for the qualitative and simultaneous detection of elevated levels of Marijuana, Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline in human urine at or above the following concentrations: Marijuana 50 ng/mL Cocaine 300 ng/mL Phencyclidine 25 ng/mL Morphine 2,000 ng/mL Methamphetamine 1,000 ng/mL Methadone 300 ng/mL Amphetamine 1,000 ng/mL Barbiturates 300 ng/mL Benzodiazepines 300 ng/mL Nortriptyline 1,000 ng/mL The test strips with an integrated cup is intended for healthcare professionals only. It is not intended for over the counter sale to non-professionals.

Source page: https://510kreport.com/device/K082977
Methodology: https://510kreport.com/methodology