# K882496: Abuscreen (R) Ontrak (TM) for Morphine

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Sep 2, 1988 after 77 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.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K973075: Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik for Morphine, Ontrak Teststik for PCP, on (1997), 9 descendants of its own
- K994164: Ontrak Teststik 2 for Cocaine/THC, Cat. 1118579 (2000), 6 descendants of its own
- K033902: Ontrak Testcup II and Onsite Cupkit (2004), 5 descendants of its own
- K060896: Modification to Ontrak Testcup II and Onsite Cupkit (2006), 4 descendants of its own
- K153192: Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests (2016), 2 descendants of its own

Source page: https://510kreport.com/device/K882496
Methodology: https://510kreport.com/methodology