510(k) · Cleared
ClearedOntrak Teststik 2 for Cocaine/THC, Cat. 1118579
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Apr 13, 2000 as substantially equivalent to K973075 (Roche Diagnostic Systems, Inc., 1997) after a 126-day review. Its family tree reaches back 2 generations to 1988. 6 later devices descend from it.
- Decided
- Apr 13, 2000
- Review
- 126 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K881817 (1988). 6 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK881817 Abuscreen (R) Ontrak (TM) for AmphetaminesRoche Diagnostic Systems, Inc. · 1988
- 1 generation backK973075 Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine…Roche Diagnostic Systems, Inc. · 1997
- This deviceK994164 Ontrak Teststik 2 for Cocaine/THC, Cat. 1118579Roche Diagnostics Corp. · 2000
- Descendant · cites it directly · 5 of its ownK033902 Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2004
- Descendant · 2 generations on · 4 of its ownK060896 Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2006
- Descendant · 3 generations on · 2 of its ownK153192 Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue…Chemtron Biotech, Inc. · 2016
- Descendant · 4 generations on · 1 of its ownK232736 Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug…Chemtron Biotech, Inc. · 2023
- Descendant · 5 generations on · 0 of its ownK252684 Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K033902Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2004 · cites it directly5descendants
- K060896Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2006 · 2 generations on4descendants
- K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc. · 2016 · 3 generations on2descendants
- K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc. · 2023 · 4 generations on1descendant
- K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881817 | Abuscreen (R) Ontrak (TM) for Amphetamines | Roche Diagnostic Systems, Inc. | 1988 | — |
| −1 | K973075 | Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik… | Roche Diagnostic Systems, Inc. | 1997 | — |
| 0 (this device) | K994164 | Ontrak Teststik 2 for Cocaine/THC, Cat. 1118579 | Roche Diagnostics Corp. | 2000 | — |
| +1 | K033902 | Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2004 | — |
| +2 | K060896 | Modification to Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2006 | — |
| +3 | K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug… | Chemtron Biotech, Inc. | 2016 | — |
| +4 | K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen… | Chemtron Biotech, Inc. | 2023 | — |
| +5 | K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | 2026 | — |
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 |
|---|---|---|
| 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 LDJ? 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 LDJ device
- #1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 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 |
|---|---|---|---|
| * | K973075 | Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik for…Summary page 1…on | Product CFR Predicate Date Predicate Name Code | Classification Device Predicate 510(k) Name Name Cleared Number OnTrak Cocaine Test 91DIO 862.3250 OnTrak 10/9/97 | K973075 TesTstik™ 2 for | System TesTstik for Cocaine/ THC Cocaine OnTrak Cannabinoid 91LDJ 862.3870 OnTrak 10/9/97 | K973075 TesTstik™ 2… | 1997 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033902 | Ontrak Testcup II and Onsite Cupkit | 2004 | 5 |
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 12 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K033902 (Varian, Inc., 2004) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K973075.
How does its category compare?
All LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, 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 | 2 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
OnTrak TesTstik 2 for Cocaine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite and cannabinoids in urine. The OnTrak TesTstik 2 for Cocaine/THC cutoff levels (300 ng/ml for cocaine and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 2 for Cocaine/THC is not intended for over-the-counter sale. OnTrak TesTstik provides only a preliminary analytical test…
Read the full statement (118 words)
OnTrak TesTstik 2 for Cocaine/THC is an in vitro diagnostic test intended for professional use for the
qualitative detection of cocaine metabolite and cannabinoids in urine. The OnTrak TesTstik 2 for
Cocaine/THC cutoff levels (300 ng/ml for cocaine and 50 ng/ml for THC) are based on the Federal
Mandatory Guidelines. OnTrak TesTstik 2 for Cocaine/THC is not intended for over-the-counter sale.
OnTrak TesTstik provides only a preliminary analytical test result. A more specific alternate chemical
method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass
spectrometry (GC/MS) is the preferred confirmation method. Clinical consideration and professional
judgment should be applied to any drug of abuse test result, particularly when preliminary positive results
are used.
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/K994164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994164: Ontrak Teststik 2 for Cocaine/THC, Cat. 1118579.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994164
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026