510(k) · Cleared
ClearedVarian, Inc. Ontrak Testcup and Ontrak Teststik
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 6, 2004 after a 46-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 6, 2004
- Review
- 46 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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 and OnTrak TesTstik products, as listed below, are in vitro diagnostic tests intended for professional use for the qualitative detection of drugs in urine at or above the stated cutoff concentrations. OnTrak TesTcup Products: OnTrak TesTcup 4; OnTrak TesTcup 5; OnTrak TesTcup 5 M2K; OnTrak TesTcup 501; OnTrak TesTcup PRO-5. OnTrak TesTstik Products: OnTrak TesTstik AMP; OnTrak TesTstik BAR; OnTrak TesTstik BNZ; OnTrak TesTstik COC; OnTrak…
Read the full statement (150 words)
OnTrak TesTcup and OnTrak TesTstik products, as listed below, are in vitro diagnostic tests intended for professional use for the qualitative detection of drugs in urine at or above the stated cutoff concentrations.
OnTrak TesTcup Products: OnTrak TesTcup 4; OnTrak TesTcup 5; OnTrak TesTcup 5 M2K; OnTrak TesTcup 501; OnTrak TesTcup PRO-5.
OnTrak TesTstik Products: OnTrak TesTstik AMP; OnTrak TesTstik BAR; OnTrak TesTstik BNZ; OnTrak TesTstik COC; OnTrak TesTstik MET; OnTrak TesTstik MOR; OnTrak TesTstik PCP; OnTrak TesTstik THC; OnTrak TesTstik 2 COC/THC; OnTrak TesTstik 3 COC/MOR/THC.
Cutoff Concentrations:
Amphetamines 1000 ng/mL
Barbiturates 200 ng/mL
Benzodiazepines 100 ng/mL
Cocaine metabolite 300 ng/mL
Methamphetamine 500 ng/mL
Morphine 300 ng/mL
Morphine (M2K) 2000 ng/mL
Phencyclidine (PCP) 25 ng/mL
Tetrahydrocannabinols (THC) 50 ng/mL
OnTrak TesTcup and OnTrak TesTstik 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 as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033659: Varian, Inc. Ontrak Testcup and Ontrak Teststik.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033659
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)
- Page last updated Nov 3, 2026