510(k) · Cleared
ClearedOntrak Testcup-5 M2K
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 Feb 23, 1999 as substantially equivalent to K964355 (Roche Diagnostic Systems, Inc., 1996) after a 20-day review. Its family tree reaches back 1 generation to 1996. 7 later devices descend from it.
- Decided
- Feb 23, 1999
- Review
- 20 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964355 (1996). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK964355 Ontrak Testcup 5 (Modification)Roche Diagnostic Systems, Inc. · 1996
- This deviceK990337 Ontrak Testcup-5 M2KRoche Diagnostics Corp. · 1999
- Descendant · cites it directly · 6 of its ownK994017 Ontrak Testcup 5 M2K, Cat. 11 1850 1Roche Diagnostics Corp. · 2000
- Descendant · 2 generations on · 5 of its ownK033902 Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2004
- Descendant · 3 generations on · 4 of its ownK060896 Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2006
- Descendant · 4 generations on · 2 of its ownK153192 Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue…Chemtron Biotech, Inc. · 2016
- Descendant · 5 generations on · 1 of its ownK232736 Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug…Chemtron Biotech, Inc. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K994017Ontrak Testcup 5 M2K, Cat. 11 1850 1Roche Diagnostics Corp. · 2000 · cites it directly6descendants
- K033902Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2004 · 2 generations on5descendants
- K060896Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2006 · 3 generations on4descendants
- K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc. · 2016 · 4 generations on2descendants
- K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc. · 2023 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964355 | Ontrak Testcup 5 (Modification) | Roche Diagnostic Systems, Inc. | 1996 | — |
| 0 (this device) | K990337 | Ontrak Testcup-5 M2K | Roche Diagnostics Corp. | 1999 | — |
| +1 | K994017 | Ontrak Testcup 5 M2K, Cat. 11 1850 1 | Roche Diagnostics Corp. | 2000 | — |
| +2 | K033902 | Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2004 | — |
| +3 | K060896 | Modification to Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2006 | — |
| +4 | K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug… | Chemtron Biotech, Inc. | 2016 | — |
| +5 | K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen… | Chemtron Biotech, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K964355 | Ontrak Testcup 5 (Modification)Summary page 1…OnTrak TesTcup®S5 Morphine test system I 862.3640 M2K 3) Predicate We claim substantial equivalence to the currently marketed Roche device Diagnostics OnTrak TesTcup 5 (K964355). 510(k) Summary, Continued 4) Device Description 5. Technology Characteristics The OnTrak TesTcup-5 M2K is an… | 1996 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994017 | Ontrak Testcup 5 M2K, Cat. 11 1850 1 | 2000 | 6 |
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?
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® 5 M2K is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup 5 M2K simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcup-5 M2K cutoff levels are based on the Federal Mandatory Guidelines.
The OnTrak TesTcup 5 M2K profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL).
OnTrak TesTcup 5 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/K990337 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990337: Ontrak Testcup-5 M2K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990337
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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