510(k) · Cleared
ClearedOntrak Testcup 5 M2K, Cat. 11 1850 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LCM Enzyme Immunoassay, Phencyclidine
Cleared on Jan 27, 2000 as substantially equivalent to K990337 (Roche Diagnostics Corp., 1999) after a 62-day review. Its family tree reaches back 2 generations to 1996. 6 later devices descend from it.
- Decided
- Jan 27, 2000
- Review
- 62 days
- Class
- Class U
- Product code
- LCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964355 (1996). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK964355 Ontrak Testcup 5 (Modification)Roche Diagnostic Systems, Inc. · 1996
- 1 generation backK990337 Ontrak Testcup-5 M2KRoche Diagnostics Corp. · 1999
- This deviceK994017 Ontrak Testcup 5 M2K, Cat. 11 1850 1Roche 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 | K964355 | Ontrak Testcup 5 (Modification) | Roche Diagnostic Systems, Inc. | 1996 | — |
| −1 | K990337 | Ontrak Testcup-5 M2K | Roche Diagnostics Corp. | 1999 | — |
| 0 (this device) | K994017 | Ontrak Testcup 5 M2K, Cat. 11 1850 1 | 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 | — |
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 LCM? 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 LCM device
- #1 K212952 Psychemedics Homogeneous Enzyme Immunoassay…score 3.5 · 2 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 |
|---|---|---|---|
| * | K990337 | Ontrak Testcup-5 M2KSummary page 1…ak TesTcup-5 | Enzyme 91LCM Unassigned M2K Immunoassay, Phencyclidine We claim substantial equivalence to the currently marketed Roche Diagnostics OnTrak TesTcup-5 M2K (K990337). 24 510(k) Summary, Continued 4) Device Description S. Technology Characteristics The OnTrak TesTcup-5 M2K i… | 1999 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K033902 (Varian, Inc., 2004) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LCM devicesLCM Enzyme Immunoassay, Phencyclidine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCM
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LCM
Too few LCM 510(k)s in any year since 2007 to give a median.
Recalls per year · LCM
No recall names LCM since 2007.
Adverse event reports per year · LCM
2in 2019
MAUDE reports naming product code LCM, 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 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
OnTrak TesTcup®5 M2K is an in vitro test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup-5 M2K simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcup-5 M2K profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL). OnTrak TesTcup-5 M2K provides only a preliminary…
Read the full statement (118 words)
OnTrak TesTcup®5 M2K is an in vitro test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup-5 M2K simultaneously tests for the presence of multiple drugs or drug metabolites.
The OnTrak TesTcup-5 M2K profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL).
OnTrak TesTcup-5 M2K 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 abuse 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/K994017 · printed Nov 5, 2026
Cite this page
510(k) Report. “K994017: Ontrak Testcup 5 M2K, Cat. 11 1850 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994017
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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