# K990337: Ontrak Testcup-5 M2K

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Feb 23, 1999 after 20 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
Longest line of descent: 1 generation back to K964355 (1996). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964355: Ontrak Testcup 5 (Modification), Roche Diagnostic Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K994017: Ontrak Testcup 5 M2K, Cat. 11 1850 1 (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
- 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

## Indications for use
OnTrak TesTcup® 5 M2K is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup 5 M2K simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcup-5 M2K cutoff levels are based on the Federal Mandatory Guidelines. The OnTrak TesTcup 5 M2K profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL). OnTrak TesTcup 5 M2K provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

Source page: https://510kreport.com/device/K990337
Methodology: https://510kreport.com/methodology