# K981771: Accusign Mop, Biosign Mop, Staus DS Mop

- Pathway: 510(k) (Traditional)
- Applicant: Princeton BioMeditech Corp.
- Decided: Jun 12, 1998 after 24 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K014193: Lifesign Doa 4 (THC/Opi/Coc/Met) (2002), 1 descendant of its own
- K023837: Lifesign Home Drug Test (Ecstasy/Met), Status Stik Met & Mdma, Accusign Stik Met & Mdma, Accustik Met & Mdma (2003), 0 descendants of its own

## Indications for use
Immunoassay for the qualitative detection of opiates in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs

Source page: https://510kreport.com/device/K981771
Methodology: https://510kreport.com/methodology