# K983387: Ontrak Testcup and Teststik Controls

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Oct 9, 1998 after 14 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K990377: Ontrak Testcup M2K and Ontrak Teststik Positive Control, Model 11 18544, Ontrak Testcup M2K and Ontrak Teststick Negativ (1999), 0 descendants of its own

## Indications for use
The ONTRAK TESTcup and TESTSTIK Controls are in vitro diagnostic devices intended for use as quality control samples for use with the ONTRAK TESTCUP and TESTSTIK systems for amphetamine, cocaine, cannabinoids (THC), morphine, phencyclidine (PCP), and barbiturates.

Source page: https://510kreport.com/device/K983387
Methodology: https://510kreport.com/methodology