510(k) · Cleared
ClearedOntrak Teststik 3 for Cocaine/Morphine/THC,Cat. 1118595
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Apr 7, 2000 as substantially equivalent to K973075 (Roche Diagnostic Systems, Inc., 1997) after a 120-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Apr 7, 2000
- Review
- 120 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K881817 (1988). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK994165 Ontrak Teststik 3 for Cocaine/Morphine/THC,Cat. 1118595Roche Diagnostics Corp. · 2000
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) | K994165 | Ontrak Teststik 3 for Cocaine/Morphine/THC,Cat. 1118595 | Roche Diagnostics Corp. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1990 | 2 | 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 DIO? 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 DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.1 · 2 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…ct CFR 1, Predicate Date Predicate Name Code Classification Device Name Predicate 510(k) - Name Cleared Number OnTrak TesTstik Cocaine Test 91DIO 862.3250 OnTrak 10/9/97 K973075 3 for Cocaine/ System TesTstik for Morphine/THC _ . Cocaine 3 ] OnTrak TesTstik Morphine Test 91DJJ 862.3640 © OnTrak 10/9/97 K97… | 1997 |
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.
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.
- 2 other devices also cite its predicate K973075.
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, 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 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
OnTrak TesTstik 3 for Cocaine/Morphine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite, morphine, and cannabinoids in urine. The OnTrak TesTstik 3 for Cacaine/Marphine/THC cutaff levels (300 ng/m! for cocaine and morphinc and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 3 for Cocaine/Morphine/THC is not intended for over-the-counter sale. OnTrak…
Read the full statement (124 words)
OnTrak TesTstik 3 for Cocaine/Morphine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite, morphine, and cannabinoids in urine. The OnTrak TesTstik 3 for Cacaine/Marphine/THC cutaff levels (300 ng/m! for cocaine and morphinc and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 3 for Cocaine/Morphine/THC is not intended for over-the-counter sale.
OnTrak Tes'T'stik 3 for Cocaine/Morphine/THC 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 applicd 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/K994165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994165: Ontrak Teststik 3 for Cocaine/Morphine/THC,Cat. 1118595.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994165
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