# K991080: Accusign MTD, Biosign MTD

- Pathway: 510(k) (Special)
- Applicant: Princeton BioMeditech Corp.
- Decided: Apr 15, 1999 after 20 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
No predicates in its family tree.
3 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K012595: Acon MTD One Step Methadone Test Strip and Test Device (2001), 2 descendants of its own
- 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
Immunoassay for the qualitative detection of methadone in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drug.

Source page: https://510kreport.com/device/K991080
Methodology: https://510kreport.com/methodology