510(k) · Cleared
ClearedOntrak Testcup M2K and Ontrak Teststik Positive Control, Model 11 18544, Ontrak Testcup M2K and Ontrak Teststick Negativ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DIF Drug Mixture Control Materials
Cleared on Feb 26, 1999 as substantially equivalent to K983387 (Roche Diagnostic Systems, Inc., 1998) after an 18-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Feb 26, 1999
- Review
- 18 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983387 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK983387 Ontrak Testcup and Teststik ControlsRoche Diagnostic Systems, Inc. · 1998
- This deviceK990377 Ontrak Testcup M2K and Ontrak Teststik Positive Control, Model 11…Roche Diagnostics Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983387 | Ontrak Testcup and Teststik Controls | Roche Diagnostic Systems, Inc. | 1998 | — |
| 0 (this device) | K990377 | Ontrak Testcup M2K and Ontrak Teststik Positive Control, Model 11 18544… | 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 DIF? 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? (3)
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 |
|---|---|---|---|
| * | K983387 | Ontrak Testcup and Teststik ControlsSummary page 2…s well as the Synchron Systems DAT Low Urine Control II and DAT High Urine Control 11 The OnTrak TesTcup and TesTstik Control was previously cleared on October 9, 1998 (K983387). This Premarket Notification [510(k)] is being submitted to the agency due to the Department of Health and Human Services Subst… | 1998 |
| * | — | Synchron Systems DAT Low Urine Control II Named without a submission number | |
| * | — | Synchron Systems DAT High Urine Control II Named without a submission number |
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 DIF devicesDIF Drug Mixture Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIF
35in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIF
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIF
1in 2016
MAUDE reports naming product code DIF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 3 | 35 | 0 | 3 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 5 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 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 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.
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/K990377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990377: Ontrak Testcup M2K and Ontrak Teststik Positive Control, Model 11 18544, Ontrak Testcup M2K and Ontrak Teststick Negativ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990377
Report an extraction error
Are you the manufacturer?
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