# K990409: Ontrak Teststik for Morphine 2000 (M2K)

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 15, 1999 after 65 days
- Product code: DMY (Gas Chromatography, Morphine)
- Device class: 2
- Regulation: 21 CFR 862.3640
- 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 K962411 (1996). 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)
- K962411: Ontrak Testcup Amphetamines, Roche Diagnostic Systems, Inc. (1996) Summary page 1.

## Indications for use
The Roche Diagnostics Corporation OnTrak TesTstik™ for Morphine 2000 (M2K) is an in vitro test intended for professional use for the qualitative detection of morphine in urine at or above a cutoff concentration of 2000 ng/mL OnTrak TesTstik provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

Source page: https://510kreport.com/device/K990409
Methodology: https://510kreport.com/methodology