# K973075: Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik for Morphine, Ontrak Teststik for PCP, on

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Oct 9, 1997 after 52 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 K881817 (1988). 5 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881817: Abuscreen (R) Ontrak (TM) for Amphetamines, Roche Diagnostic Systems, Inc. (1988) Summary page 3.
- K881815: Abuscreen (R) Ontrak (TM) for Cocaine, Roche Diagnostic Systems, Inc. (1988) Summary page 3.
- K882496: Abuscreen (R) Ontrak (TM) for Morphine, Roche Diagnostic Systems, Inc. (1988) Summary page 3.
- K895906: Abuscreen Ontrak for Phencyclidine (PCP), Roche Diagnostic Systems, Inc. (1990) Summary page 3.
- K904856: Abuscreen Ontrak for THC, Roche Diagnostic Systems, Inc. (1990) Summary page 3.

## Most influential descendants
- 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
- 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
1. The ONTRAK TESTSTIK for Amphetamines is an in vitro diagnostic test intended for professional use for the qualitative detection of amphetamines in urine at or above a cutoff concentration of 1000 ng/mL. 2. The ONTRAK TESTSTIK for Cocaine is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite in urine at or above a cutoff concentration of 300 ng/mL. 3. The ONTRAK TESTSTIK for Morphine is an in vitro diagnostic test intended for professional use for the qualitative detection of morphine in urine at or above a cutoff concentration of 300 ng/mL 4. The ONTRAK TESTSTIK for PCP is an in vitro diagnostic test intended for professional use for the qualitative detection of phencyclidine in urine at or above a cutoff concentration of 25 ng/mL. 5. The ONTRAK TESTSTIK for THC is an ir vitro diagnostic test intended for professional use for the qualitative detection of cannabinoids in urine at or above a cutoff concentration of 50 ng/mL.

Source page: https://510kreport.com/device/K973075
Methodology: https://510kreport.com/methodology