# K061005: Accustep Doa Single and Multi-Strip Screen Panels

- Pathway: 510(k) (Traditional)
- Applicant: Applied Dna Technologies, Inc.
- Decided: Oct 4, 2006 after 176 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945610 (1995). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023946: Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug Multi-Line Screen Test Device, ACON Laboratories, Inc. (2003) Summary page 2.
- K020313: Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug Multi-Line Screen Test Device, Acon Laboratories Co. (2002) Summary page 2.

## Most influential descendants
- K082977: Bionexia Opticup Multi-Strip Doa Dipstick Test Integrated Cup (2009), 0 descendants of its own

## Indications for use
The Applied DNA Technologies ACCUSTEP DOA Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to ten 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/ml Barbiturate BAR Secobarbital 300 ng/ml Benzodiazepines BZO Oxazepam 300 ng/ml Cocaine COC Benzoylecgonine 300 ng/ml Marijuana THC i1-nor-A9 -THC9-COOH 50 ng/ml Methamphetamine MET Methamphetamine 1000 ng/ml Methadone MTD Methadone 300 nglml Morphine MOR Morphine 2000 ng/ml Phencyclidine PCP Phencyclidine 25 ng/ml Nortriptyline NOR Nortriptyline 1000 ng/ml These test kits are intended for health care professional use only. 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/K061005
Methodology: https://510kreport.com/methodology