510(k) · Cleared
ClearedLabcorp Fentanyl Urine Visual Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtox Diagnostics, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Jan 29, 2026 as substantially equivalent to K232736 (Chemtron Biotech, Inc., 2023) after a 157-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Jan 29, 2026
- Review
- 157 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K964355 (1996). 46 ancestors in all, the oldest K881816 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK964355 Ontrak Testcup 5 (Modification)Roche Diagnostic Systems, Inc. · 1996
- 6 generations backK990337 Ontrak Testcup-5 M2KRoche Diagnostics Corp. · 1999
- 5 generations backK994017 Ontrak Testcup 5 M2K, Cat. 11 1850 1Roche Diagnostics Corp. · 2000
- 4 generations backK033902 Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2004
- 3 generations backK060896 Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc. · 2006
- 2 generations backK153192 Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue…Chemtron Biotech, Inc. · 2016
- 1 generation backK232736 Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug…Chemtron Biotech, Inc. · 2023
- This deviceK252684 Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K964355 | Ontrak Testcup 5 (Modification) | Roche Diagnostic Systems, Inc. | 1996 | — |
| −6 | K990337 | Ontrak Testcup-5 M2K | Roche Diagnostics Corp. | 1999 | — |
| −5 | K994017 | Ontrak Testcup 5 M2K, Cat. 11 1850 1 | Roche Diagnostics Corp. | 2000 | — |
| −4 | K033902 | Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2004 | — |
| −3 | K060896 | Modification to Ontrak Testcup II and Onsite Cupkit | Varian, Inc. | 2006 | — |
| −2 | K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug… | Chemtron Biotech, Inc. | 2016 | — |
| −1 | K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen… | Chemtron Biotech, Inc. | 2023 | — |
| 0 (this device) | K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 4 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2012 | 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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 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? (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 |
|---|---|---|---|
| * | K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Summary page 5…lass II 862.3650, Opiate Test System (Fentanyl) Clinical Toxicology Predicate Devices Chemtron Biotech, Inc., Chemtrue® Drug Screen Fentanyl Test (K232736) Reference Method: Fentanyl Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS… | 2023 |
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 30 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 46 ancestors have a recall of any class.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
The Labcorp Fentanyl Urine Visual Test is a lateral flow competitive immunoassay for the rapid qualitative detection of norfentanyl (fentanyl metabolite) in human urine at a cutoff of 5 ng/mL. It is intended for prescription use. For in vitro diagnostic use only. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result.…
Read the full statement (103 words)
The Labcorp Fentanyl Urine Visual Test is a lateral flow competitive immunoassay for the rapid qualitative detection of
norfentanyl (fentanyl metabolite) in human urine at a cutoff of 5 ng/mL. It is intended for prescription use. For in vitro
diagnostic use only.
This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug
test result, particularly in evaluating a preliminary positive result. To confirm preliminary positive results, a more specific
analytical method must be used. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography Tandem
Mass Spectrometry (LC-MS/MS), and High Performance Liquid Chromatography (HPLC) are the preferred confirmatory
methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252684 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252684: Labcorp Fentanyl Urine Visual Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252684
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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