510(k) · Cleared
ClearedOntrak Teststik for Morphine 2000 (M2K)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DMY Gas Chromatography, Morphine
Cleared on Apr 15, 1999 as substantially equivalent to K962411 (Roche Diagnostic Systems, Inc., 1996) after a 65-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Apr 15, 1999
- Review
- 65 days
- Class
- Class II
- Product code
- DMY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962411 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK962411 Ontrak Testcup AmphetaminesRoche Diagnostic Systems, Inc. · 1996
- This deviceK990409 Ontrak Teststik for Morphine 2000 (M2K)Roche Diagnostics Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962411 | Ontrak Testcup Amphetamines | Roche Diagnostic Systems, Inc. | 1996 | — |
| 0 (this device) | K990409 | Ontrak Teststik for Morphine 2000 (M2K) | Roche Diagnostics Corp. | 1999 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DMY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962411 | Ontrak Testcup AmphetaminesSummary page 1…lass CFR Classification OnTrak TesTcup® Morphine test system I 862.3640 M2K We claim substantial equivalence to the currently marketed Roche Diagnostics OnTrak TesTcup (K962411). 510(k) Summary, Continued 4) Device Description 5. Technology Characteristics 6. Substantial Equivalence Th… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All DMY devicesDMY Gas Chromatography, Morphine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DMY
FDA has decided no DMY device since 2007.
Median 510(k) review, days · DMY
Too few DMY 510(k)s in any year since 2007 to give a median.
Recalls per year · DMY
No recall names DMY since 2007.
Adverse event reports per year · DMY
No MAUDE report names DMY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990409 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990409: Ontrak Teststik for Morphine 2000 (M2K).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990409
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026