# K041743: Acon Tri-Fect Drug Screen Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Sep 9, 2004 after 73 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: 2 generations back to K945610 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011673: Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test Device, ACON Laboratories, Inc. (2001) Summary page 3.
- K012824: Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test Device, ACON Laboratories, Inc. (2001) Summary page 3.
- K012300: Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step Benzodiazepines Test Device, ACON Laboratories, Inc. (2001) Summary page 3.
- K010841: Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test Device, ACON Laboratories, Inc. (2001) Summary page 3.
- K003557: Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana Test Device (Urine), ACON Laboratories, Inc. (2001) Summary page 3.
- K022589: Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test Device, ACON Laboratories, Inc. (2002) Summary page 3.
- K013380: Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test Device, ACON Laboratories, Inc. (2001) Summary page 3.
- K033047: Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test Device, ACON Laboratories, Inc. (2004) Summary page 3.
- K011730: Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test Device, ACON Laboratories, Inc. (2001) Summary page 3.
- K040445: Acon PPX One Step Propoxyphene Test Strip and Acon PPX Step Propoxyphene Test Device, ACON Laboratories, Inc. (2004) Summary page 3.
- K021526: Acon Tca One Step Tricyclic Antidepressant Test Strip and Device, ACON Laboratories, Inc. (2002) Summary page 3.

## Indications for use
The ACON TRI-fect Drug Screen Test Device is a rapid chromatographic immunoassay for the qualitative and simultaneous detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in urine. The designated cut-off concentrations for these drugs are as follows: Amphetamine 1,000 ng/mL, Barbiturates 300 ng/mL, Benzodiazepines 300 ng/mL, Cocaine 300 ng/mL, Marijuana 50 ng/mL, Methylenedioxymethamphetamine 500 ng/mL, Opiates 300 ng/mL, Oxycodone 100 ng/mL, Phencyclidine 25 ng/mL, Propoxyphene 300 ng/mL and Tricyclic Antidepressants 1,000 ng/mL. They are intended for healthcare professionals including professionals at point-of-care sites. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is 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 used.

Source page: https://510kreport.com/device/K041743
Methodology: https://510kreport.com/methodology