# K994165: Ontrak Teststik 3 for Cocaine/Morphine/THC,Cat. 1118595

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 7, 2000 after 120 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- 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.
No later device cites it as a predicate yet.
0 of 7 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.

## Indications for use
OnTrak TesTstik 3 for Cocaine/Morphine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite, morphine, and cannabinoids in urine. The OnTrak TesTstik 3 for Cacaine/Marphine/THC cutaff levels (300 ng/m! for cocaine and morphinc and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 3 for Cocaine/Morphine/THC is not intended for over-the-counter sale. OnTrak Tes'T'stik 3 for Cocaine/Morphine/THC 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 applicd to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K994165
Methodology: https://510kreport.com/methodology