510(k) · Cleared
ClearedHealgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healgen Scientific,, LLC · JXM Enzyme Immunoassay, Benzodiazepine
Cleared on May 13, 2015 as substantially equivalent to K142280 (Healgen Scientific,, LLC, 2014) and 3 other predicates after a 90-day review. Its family tree reaches back 3 generations to 2005.
- Decided
- May 13, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K050186 (2005). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK050186 Ameditech Immutest Multi-Drug Screen Panel IiiAmeditech, Inc. · 2005 · Recalled
- 2 generations backK052115 First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc)…First Check Diagnostics, LLC · 2005 · Recalled
- 1 generation backK140546 Healgen THC One Step Marijuana Test , Healgen Mamp One Step…Healgen Scientific,, LLC · 2014 · Recalled
- This deviceK150356 Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip…Healgen Scientific,, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K050186 | Ameditech Immutest Multi-Drug Screen Panel Iii | Ameditech, Inc. | 2005 | 3 |
| −2 | K052115 | First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine… | First Check Diagnostics, LLC | 2005 | 86 |
| −1 | K140546 | Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine Test | Healgen Scientific,, LLC | 2014 | 2 |
| 0 (this device) | K150356 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 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 JXM? 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 JXM device
- #1 K243498 Alinity c Benzodiazepines Reagent Kitscore 8.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K142280 | Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip…Summary page 5…colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region. 6. Predicate Devices: K142280; Healgen Oxazepam and Morphine Tests (Strip, Cassette, Dip Card, Cup) K143187; Healgen Amphetamine and Oxycodone Tests (Strip,… | 2014 |
| * | K143187 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test…Summary page 5…ontrol, a color line will always appear at the control region. 6. Predicate Devices: K142280; Healgen Oxazepam and Morphine Tests (Strip, Cassette, Dip Card, Cup) K143187; Healgen Amphetamine and Oxycodone Tests (Strip, Cassette, Dip Card, Cup) K141647; Healgen Cocaine and Morphine Tests (Strip,… | 2015 |
| * | K141647 | Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip (Cassette, Cup, Dip Card)Summary page 5…K142280; Healgen Oxazepam and Morphine Tests (Strip, Cassette, Dip Card, Cup) K143187; Healgen Amphetamine and Oxycodone Tests (Strip, Cassette, Dip Card, Cup) K141647; Healgen Cocaine and Morphine Tests (Strip, Cassette, Dip Card, Cup) K140546; Healgen Marijuana and Methamphetamine Tests (Str… | 2014 |
| * | K140546 | Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine TestSummary page 5…) K143187; Healgen Amphetamine and Oxycodone Tests (Strip, Cassette, Dip Card, Cup) K141647; Healgen Cocaine and Morphine Tests (Strip, Cassette, Dip Card, Cup) K140546; Healgen Marijuana and Methamphetamine Tests (Strip, Cassette, Dip Card, Cup) 7. Intended Use / Indications for Use Healgen M… | 2014 |
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 10 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 3 of the 6 ancestors have a recall of any class.
- 3 other devices also cite its predicate K142280.
How does its category compare?
All JXM devicesJXM Enzyme Immunoassay, Benzodiazepine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JXM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JXM
Too few JXM 510(k)s in any year since 2007 to give a median.
Recalls per year · JXM
79in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXM
6in 2025
MAUDE reports naming product code JXM, 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 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 79 | 5 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine and Oxycodone in human urine at the cutoff concentrations of: Drug(Identifier) Cut-off level Amphetamine(AMP) 1000 ng/mL Oxazepam (OXA) 300 ng/mL Cocaine (COC) 300 ng/mL Cannabinoids (THC) 50…
Read the full statement (185 words)
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine and Oxycodone in human urine at the cutoff concentrations of:
Drug(Identifier) Cut-off level
Amphetamine(AMP) 1000 ng/mL
Oxazepam (OXA) 300 ng/mL
Cocaine (COC) 300 ng/mL
Cannabinoids (THC) 50 ng/mL
Methamphetamine (MET) 1000 ng/mL
Morphine (MOR) 2000 ng/mL
Oxycodone (OXY) 100 ng/mL
Configuration of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs oxazepam and oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
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/K150356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150356: Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150356
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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