# K001421: Ontrak Testcup 501, Model 3016633

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 12, 2000 after 68 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- 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
- K232736: Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test (2023), 1 descendant of its own
- K252684: Labcorp Fentanyl Urine Visual Test (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K001421
Methodology: https://510kreport.com/methodology