# K983174: Ontrak Teststik for Barbiturates, Ontrak Teststik for Benzodiazepines

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Nov 18, 1998 after 69 days
- Product code: JXM (Enzyme Immunoassay, Benzodiazepine)
- Device class: 2
- Regulation: 21 CFR 862.3170
- 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 K881816 (1988). 2 ancestors in all.
6 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)
- K881816: Abuscreen (R) Ontrak (TM) for Barbiturates, Roche Diagnostic Systems, Inc. (1988) Summary page 3.
- K910590: Abuscreen Ontrak for Benzodiazepine, Roche Diagnostic Systems, Inc. (1991) Summary page 3.

## 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
1. The ONTRAK TESTSTIK for Barbiturates is an in vitro diagnostic test intended for professional use for the qualitative detection of barbiturates in urine at or above a cutoff concentration of 200 ng/mL. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose. 2. The ONTRAK TESTSTIK for Benzodiazepines is an in vitro diagnostic test intended for professional use for the qualitative detection of benzodiazepines in urine at or above a cutoff concentration of 200 ng/mL. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose.

Source page: https://510kreport.com/device/K983174
Methodology: https://510kreport.com/methodology