# K983388: Ontrak Testcup-ER

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Nov 18, 1998 after 54 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: 1 generation back to K881816 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 2.
- K910590: Abuscreen Ontrak for Benzodiazepine, Roche Diagnostic Systems, Inc. (1991) Summary page 2.

## Indications for use
The ONTRAK TESTCUP -er is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. ONTRAK TESTCUP-er simultaneously tests for the presence of multiple drugs or drug metabolites. The ONTRAK TESTCUP - er profile consists of amphetamines (1000 ng/mL cutoff), cocaine metabolite (300 ng/mL cutoff), barbiturates (200 ng/mL cutoff), benzodiazepines (200 ng/mL), and morphine (300 ng/mL cutoff). Measurements obtained by this device are used in the diagnosis and treatment of amphetamine, cocaine, barbiturate, benzodiazepine, and morphine use or overdose.

Source page: https://510kreport.com/device/K983388
Methodology: https://510kreport.com/methodology