510(k) · Cleared
ClearedModification to Ontrak Testcup II and Onsite Cupkit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian, Inc. · DJC Thin Layer Chromatography, Methamphetamine
Cleared on Jun 9, 2006 as substantially equivalent to K033902 (Varian, Inc., 2004) after a 67-day review. Its family tree reaches back 4 generations to 1996. 4 later devices descend from it.
- Decided
- Jun 9, 2006
- Review
- 67 days
- Class
- Class II
- Product code
- DJC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K964355 (1996). 15 ancestors in all, the oldest K881816 (1988). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK964355 Ontrak Testcup 5 (Modification)Roche Diagnostic Systems, Inc. · 1996
- 3 generations backK990337 Ontrak Testcup-5 M2KRoche Diagnostics Corp. · 1999
- 2 generations backK994017 Ontrak Testcup 5 M2K, Cat. 11 1850 1Roche Diagnostics Corp. · 2000
- 1 generation backK033902 Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2004
- This deviceK060896 Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK153192 Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue…Chemtron Biotech, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK232736 Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug…Chemtron Biotech, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK252684 Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK143599 Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests…Chemtron Biotech, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc. · 2016 · cites it directly2descendants
- K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc. · 2023 · 2 generations on1descendant
- K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026 · 3 generations on0descendants
- K143599Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000Chemtron Biotech, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964355 | Ontrak Testcup 5 (Modification) | Roche Diagnostic Systems, Inc. | 1996 | — |
| −3 | K990337 | Ontrak Testcup-5 M2K | Roche Diagnostics Corp. | 1999 | — |
| −2 | K994017 | Ontrak Testcup 5 M2K, Cat. 11 1850 1 | Roche Diagnostics Corp. | 2000 | — |
| −1 | K033902 | Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2004 | — |
| 0 (this device) | K060896 | Modification to Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2006 | — |
| +1 | K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug… | Chemtron Biotech, Inc. | 2016 | — |
| +2 | K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen… | Chemtron Biotech, Inc. | 2023 | — |
| +3 | K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | 2026 | — |
| +1 | 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 |
|---|---|---|
| 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 DJC? 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 DJC device
- #1 K253705 Healgen® Accurate Oral Fluid Drug Testscore 12.2 · 5 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K033902 | Ontrak Testcup II and Onsite CupkitSummary page 1…862.3610 3) Predicate We claim substantial equivalence to these legally marketed devices: Device OnTrak TesTcup® II and OnSite CupKit TM , K033902, 01/20/2004 4) Device The OnTrak TesTcup II and OnSite Cupkit assays contained in this Description submission are i… | 2004 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K153192 (Chemtron Biotech, Inc., 2016) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DJC devicesDJC Thin Layer Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJC
258in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJC
No recall names DJC since 2007.
Adverse event reports per year · DJC
2in 2018
MAUDE reports naming product code DJC, 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 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 3 | 258 | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 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 drug or drug metabolite 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: 50 ng/mL
Methamphetamine: 300 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 as stated in the FDA summary.
https://510kreport.com/device/K060896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060896: Modification to 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/K060896
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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