# K990377: Ontrak Testcup M2K and Ontrak Teststik Positive Control, Model 11 18544, Ontrak Testcup M2K and Ontrak Teststick Negativ

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Feb 26, 1999 after 18 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
Longest line of descent: 1 generation back to K983387 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983387: Ontrak Testcup and Teststik Controls, Roche Diagnostic Systems, Inc. (1998) Summary page 2.
- (no number) Synchron Systems DAT Low Urine Control II: named in the summary without a submission number
- (no number) Synchron Systems DAT High Urine Control II: named in the summary without a submission number

## Indications for use
The Roche Diagnostics Corporation OnTrak TesTcup M2K/OnTrak TesTstik Controls are quality control samples for use with the OnTrak TesTcup M2K and OnTrak TesTstik systems for amphetamine, barbiturates, benzodiazepines, cocaine, morphine 2000 (M2K), phencyclidine (PCP) and THC.

Source page: https://510kreport.com/device/K990377
Methodology: https://510kreport.com/methodology