510(k) · Cleared
ClearedOntrak Testcup II and Onsite Cupkit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Jan 20, 2004 as substantially equivalent to K001421 (Roche Diagnostics Corp., 2000) and 3 other predicates after a 34-day review. Its family tree reaches back 3 generations to 1996. 5 later devices descend from it.
- Decided
- Jan 20, 2004
- Review
- 34 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K964355 (1996). 14 ancestors in all, the oldest K881816 (1988). 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK964355 Ontrak Testcup 5 (Modification)Roche Diagnostic Systems, Inc. · 1996
- 2 generations backK990337 Ontrak Testcup-5 M2KRoche Diagnostics Corp. · 1999
- 1 generation backK994017 Ontrak Testcup 5 M2K, Cat. 11 1850 1Roche Diagnostics Corp. · 2000
- This deviceK033902 Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK060896 Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK153192 Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue…Chemtron Biotech, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK232736 Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug…Chemtron Biotech, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK252684 Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK143599 Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests…Chemtron Biotech, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K060896Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2006 · cites it directly4descendants
- K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc. · 2016 · 2 generations on2descendants
- K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc. · 2023 · 3 generations on1descendant
- K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026 · 4 generations on0descendants
- K143599Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000Chemtron Biotech, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964355 | Ontrak Testcup 5 (Modification) | Roche Diagnostic Systems, Inc. | 1996 | — |
| −2 | K990337 | Ontrak Testcup-5 M2K | Roche Diagnostics Corp. | 1999 | — |
| −1 | K994017 | Ontrak Testcup 5 M2K, Cat. 11 1850 1 | Roche Diagnostics Corp. | 2000 | — |
| 0 (this device) | K033902 | Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2004 | — |
| +1 | K060896 | Modification to Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2006 | — |
| +2 | K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug… | Chemtron Biotech, Inc. | 2016 | — |
| +3 | K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen… | Chemtron Biotech, Inc. | 2023 | — |
| +4 | K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | 2026 | — |
| +2 | K143599 | Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 | Chemtron Biotech, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 4 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K001421 | Ontrak Testcup 501, Model 3016633 | 2000 |
| * | K994017 | Ontrak Testcup 5 M2K, Cat. 11 1850 1Summary page 1…im substantial equivalence to these currently marketed devices: Device OnTrak TesTcupS 501, KOO01421, 7/12/2000 OnTrak TesTcup 5 M2K, K994017, 1/27/2000 OnTrak TesTstik BNZ, K983 174, 11/18/98 OnTrak TesTstikg 2 COC/THC, K994 164, 4/13… | 2000 |
| * | K983174 | Ontrak Teststik for Barbiturates, Ontrak Teststik for BenzodiazepinesSummary page 1…ices: Device OnTrak TesTcupS 501, KOO01421, 7/12/2000 OnTrak TesTcup 5 M2K, K994017, 1/27/2000 OnTrak TesTstik BNZ, K983 174, 11/18/98 OnTrak TesTstikg 2 COC/THC, K994 164, 4/13/2000 4) Device The OnTrak TesTcup II and OnSite… | 1998 |
| * | K994164 | Ontrak Teststik 2 for Cocaine/THC, Cat. 1118579Summary page 1…2/2000 OnTrak TesTcup 5 M2K, K994017, 1/27/2000 OnTrak TesTstik BNZ, K983 174, 11/18/98 OnTrak TesTstikg 2 COC/THC, K994 164, 4/13/2000 4) Device The OnTrak TesTcup II and OnSite Cupkit assays contained in this submission Description are… | 2000 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060896 | Modification to Ontrak Testcup II and Onsite Cupkit | 2006 | 4 |
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 8 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K060896 (Varian, Inc., 2006) has gone furthest, with 4 descendants of its own.
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?
TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for the qualitative detection of drugs or drug metabolites in urine at or above the stated cutoff concentrations.
Cutoff Concentrations:
Amphetamines: 1000 ng/mL Morphine: 300 ng/mL
Benzodiazepines: 200 ng/mL Morphine (M2K): 2000 ng/mL
Cocaine metabolite: 300 ng/mL Phencyclidine (PCP): 25 ng/mL
Methamphetamine: 500 ng/mL Tetrahydrocannabinols (THC): 50 ng/mL
TesTcup II and CupKit products provide 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/K033902 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033902: Ontrak Testcup II and Onsite Cupkit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033902
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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