# K080467: Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar, Bzo, Coc, Met, MTD, Mor, PCP, Tca, THC,

- Pathway: 510(k) (Traditional)
- Applicant: Applied Dna Technologies, Inc.
- Decided: Nov 25, 2008 after 278 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: 2 generations back to K000273 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022589: Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test Device, ACON Laboratories, Inc. (2002) Summary page 2.
- K013380: Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test Device, ACON Laboratories, Inc. (2001) Summary page 2.

## Indications for use
The Applied DNA Technologies BionexiaTM DOA Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to thirteen of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows: Analyte — Abbreviation — Calibrator — Cutoff Concentration Amphetamine — AMP — Amphetamine — 1000 ng/mi Barbiturate — BAR — Secobarbital — 300 ng/ml Benzodiazepines — BZO — Oxazepam — 300 ng/mi Cocaine — COC — Benzoylecgonine — 300 ng/ml Marijuana — THC — 11-nor-A9 -THC9-COOH — 50 ng/ml Methamphetamine — MET — Methamphetamine — 1000 ng/mi Methadone — MTD — Methadone — 300 ng/ml Morphine — MOR — Morphine — 2000 ng/ml Morphine — MOR — Morphine — 300 ng/ml Phencyclidine — PCP — Phencyclidine — 25 ng/mi Nortriptyline — NOR — Nortriptyline — 1000 ng/ml Ecstasy — MDMA — 3,4-Methylenediioxy-MET — 500 ng/ml Buprenorphine — BUP — BUP-3-D-Glucuronide — 10 ng/ml EDDP — EDDP — 2-ethylidene-1,5-dimethyl- 3,3-diphenylpyrrolidine — 100 ng/mi For health care professionals use including professionals at point of care sites (POC) to assist in the determination of drug compliance. This assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Source page: https://510kreport.com/device/K080467
Methodology: https://510kreport.com/methodology