510(k) · Cleared
ClearedOntrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik for Morphine, Ontrak Teststik for PCP, on
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Oct 9, 1997 as substantially equivalent to K881817 (Roche Diagnostic Systems, Inc., 1988) and 4 other predicates after a 52-day review. Its family tree reaches back 1 generation to 1988. 9 later devices descend from it.
- Decided
- Oct 9, 1997
- Review
- 52 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K881817 (1988). 5 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK881817 Abuscreen (R) Ontrak (TM) for AmphetaminesRoche Diagnostic Systems, Inc. · 1988
- This deviceK973075 Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine…Roche Diagnostic Systems, Inc. · 1997
- Descendant · cites it directly · 6 of its ownK994164 Ontrak Teststik 2 for Cocaine/THC, Cat. 1118579Roche 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 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K994164Ontrak Teststik 2 for Cocaine/THC, Cat. 1118579Roche 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 | K881817 | Abuscreen (R) Ontrak (TM) for Amphetamines | Roche Diagnostic Systems, Inc. | 1988 | — |
| 0 (this device) | K973075 | Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik… | Roche Diagnostic Systems, Inc. | 1997 | — |
| +1 | K994164 | Ontrak Teststik 2 for Cocaine/THC, Cat. 1118579 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K881817 | Abuscreen (R) Ontrak (TM) for AmphetaminesSummary page 3…alence. Table 2 Proprietary Name Predicate Product Name K number |Date of substantial equivalence ONTRAK TESTSTIK for... Amphetamines Abuscreen ONTRAK for Amphetamines |K881817/A {7/29/88 Cocaine Abuscreen ONTRAK for Cocaine K881815 |7/29/88 Morphine Abuscreen ONTRAK for Morphine K882496 9/2/88 PCP Abuscr… | 1988 |
| * | K881815 | Abuscreen (R) Ontrak (TM) for CocaineSummary page 3…K number |Date of substantial equivalence ONTRAK TESTSTIK for... Amphetamines Abuscreen ONTRAK for Amphetamines |K881817/A {7/29/88 Cocaine Abuscreen ONTRAK for Cocaine K881815 |7/29/88 Morphine Abuscreen ONTRAK for Morphine K882496 9/2/88 PCP Abuscreen ONTRAK for PCP K895906 |1/26/90 THC Abuscreen ONTRAK… | 1988 |
| * | K882496 | Abuscreen (R) Ontrak (TM) for MorphineSummary page 3…IK for... Amphetamines Abuscreen ONTRAK for Amphetamines |K881817/A {7/29/88 Cocaine Abuscreen ONTRAK for Cocaine K881815 |7/29/88 Morphine Abuscreen ONTRAK for Morphine K882496 9/2/88 PCP Abuscreen ONTRAK for PCP K895906 |1/26/90 THC Abuscreen ONTRAK for THC K904856 |12/13/90 Description of the Device/S… | 1988 |
| * | K895906 | Abuscreen Ontrak for Phencyclidine (PCP)Summary page 3…Amphetamines |K881817/A {7/29/88 Cocaine Abuscreen ONTRAK for Cocaine K881815 |7/29/88 Morphine Abuscreen ONTRAK for Morphine K882496 9/2/88 PCP Abuscreen ONTRAK for PCP K895906 |1/26/90 THC Abuscreen ONTRAK for THC K904856 |12/13/90 Description of the Device/Statement of Intended Use: The 5 ONTRAK TEST… | 1990 |
| * | K904856 | Abuscreen Ontrak for THCSummary page 3…reen ONTRAK for Cocaine K881815 |7/29/88 Morphine Abuscreen ONTRAK for Morphine K882496 9/2/88 PCP Abuscreen ONTRAK for PCP K895906 |1/26/90 THC Abuscreen ONTRAK for THC K904856 |12/13/90 Description of the Device/Statement of Intended Use: The 5 ONTRAK TESTSTIK Assays contained in this submission are i… | 1990 |
What descends from it? (9)
3 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?
- None of the 5 ancestors has a recall.
- Of its descendants, K994164 (Roche Diagnostics Corp., 2000) has gone furthest, with 6 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?
1. The ONTRAK TESTSTIK for Amphetamines is an in vitro diagnostic test intended for professional use for the qualitative detection of amphetamines in urine at or above a cutoff concentration of 1000 ng/mL. 2. The ONTRAK TESTSTIK for Cocaine is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite in urine at or above a cutoff concentration of 300 ng/mL. 3. The ONTRAK TESTSTIK for Morphine is an in…
Read the full statement (166 words)
1. The ONTRAK TESTSTIK for Amphetamines is an in vitro diagnostic test intended for professional use for the qualitative detection of amphetamines in urine at or above a cutoff concentration of 1000 ng/mL.
2. The ONTRAK TESTSTIK for Cocaine is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite in urine at or above a cutoff concentration of 300 ng/mL.
3. The ONTRAK TESTSTIK for Morphine is an in vitro diagnostic test intended for professional use for the qualitative detection of morphine in urine at or above a cutoff concentration of 300 ng/mL
4. The ONTRAK TESTSTIK for PCP is an in vitro diagnostic test intended for professional use for the qualitative detection of phencyclidine in urine at or above a cutoff concentration of 25 ng/mL.
5. The ONTRAK TESTSTIK for THC is an ir vitro diagnostic test intended for professional use for the qualitative detection of cannabinoids in urine at or above a cutoff concentration of 50 ng/mL.
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/K973075 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973075: Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik for Morphine, Ontrak Teststik for PCP, on.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973075
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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