# K031759: Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card

- Pathway: 510(k) (Special)
- Applicant: ACON Laboratories, Inc.
- Decided: Aug 4, 2003 after 59 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: 1 (0 Class I)
- 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.
83 later devices descend from it; 3 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 4.
- 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 4.

## Most influential descendants
- K061718: Innovacon Spectrum II Test Card (2006), 80 descendants of its own
- K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (2013), 55 descendants of its own
- K140748: One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard (2014), 16 descendants of its own
- K182701: Wondfo T-Cup Multi-Drug Urine Test Cup (2018), 13 descendants of its own
- K142800: Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard (2014), 13 descendants of its own

## Recalls of this device
- Feb 12, 2007 · Not classified · Z-0733-2007: The product may produce a faint line which could be interpreted as a false negative test result .

## Indications for use
The ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card with three types of Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup) are rapid chromatographic immunoassays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic Antidepressants and Methylenedioxymethamphetamine in human urine at the cutoff concentrations of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 1,000 ng/mL for Amphetamine, 2,000 or 300 ng/mL for Opiates (OPI2000 or MOP300), 25 ng/mL for Phencyclidine, 300 ng/mL for Benzodiazepine, 300 ng/mL for Methadone, 300 ng/mL for Barbiturate, 1,000 ng/mL for Tricyclic Antidepressants, and 500 ng/mL for Methylenedioxymethamphetamine These assay systems can only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, especially when preliminary positive results are indicated. They are only intended for healthcare professionals including professionals at point of care sites.

Source page: https://510kreport.com/device/K031759
Methodology: https://510kreport.com/methodology