# K012595: Acon MTD One Step Methadone Test Strip and Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Oct 15, 2001 after 66 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991080 (1999). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991080: Accusign MTD, Biosign MTD, Princeton BioMeditech Corp. (1999) Summary page 2.

## Most influential descendants
- K092048: One Step Eddp (Methadone Metabolite) Test Strip (2010), 0 descendants of its own
- K052197: First Sign Drug of Abuse Urine Screening Test (2006), 0 descendants of its own

## Indications for use
The ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are rapid chromatographic immunoassays for the qualitative detection of Methadone in human urine at a cut-off concentration of 300 ng/mL. They are intended for healthcare professionals and professional point-of-care use.

Source page: https://510kreport.com/device/K012595
Methodology: https://510kreport.com/methodology