510(k) · Cleared
ClearedOntrak Testcup M2K, Model Cat. 11 1849 8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Apr 15, 1999 as substantially equivalent to K974840 (Roche Diagnostic Systems, Inc., 1998) after a 65-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Apr 15, 1999
- Review
- 65 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935550 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK935550 Abuscreen Online Negative Cal/Control Cal Pack and Mil Calibration…Roche Diagnostic Systems, Inc. · 1994
- 1 generation backK974840 Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates…Roche Diagnostic Systems, Inc. · 1998
- This deviceK990399 Ontrak Testcup M2K, Model Cat. 11 1849 8Roche Diagnostics Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935550 | Abuscreen Online Negative Cal/Control Cal Pack and Mil Calibration Pack | Roche Diagnostic Systems, Inc. | 1994 | — |
| −1 | K974840 | Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration… | Roche Diagnostic Systems, Inc. | 1998 | — |
| 0 (this device) | K990399 | Ontrak Testcup M2K, Model Cat. 11 1849 8 | Roche Diagnostics Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
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 DKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K974840 | Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration Pack…Summary page 1…on 1 Class Predicate Date Predicate Name ! Name i Classification | Device Name | Predicate 510(k) | Name Cleared Number OnTrak Morphine I 862.3640 | Abuscreen 04/24/98 | K974840 TesTstik for | test system Online II for Morphine Opiates 2000 (M2K) 300/2000 3) Predicate We claim substantial equivalence to th… | 1998 |
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K974840.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | 0 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
OnTrak TesTcup® M2K is an in vitro test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup M2K simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcup M2K cutoff levels are based on the Federal Mandatory Guidelines.
The OnTrak TesTcup M2K profile (cutoff) consists of d,l-amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL) and morphine (2000 ng/mL).
OnTrak TesTcup M2K 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/K990399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990399: Ontrak Testcup M2K, Model Cat. 11 1849 8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990399
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