# K994164: Ontrak Teststik 2 for Cocaine/THC, Cat. 1118579

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 13, 2000 after 126 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K881817 (1988). 6 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973075: Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik for Morphine, Ontrak Teststik for PCP, on, Roche Diagnostic Systems, Inc. (1997) Summary page 1.

## 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

## Indications for use
OnTrak TesTstik 2 for Cocaine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite and cannabinoids in urine. The OnTrak TesTstik 2 for Cocaine/THC cutoff levels (300 ng/ml for cocaine and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 2 for Cocaine/THC is not intended for over-the-counter sale. OnTrak TesTstik provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmation method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K994164
Methodology: https://510kreport.com/methodology