# K150356: Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card

- Pathway: 510(k) (Special)
- Applicant: Healgen Scientific,, LLC
- Decided: May 13, 2015 after 90 days
- Product code: JXM (Enzyme Immunoassay, Benzodiazepine)
- Device class: 2
- Regulation: 21 CFR 862.3170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K050186 (2005). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142280: Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card), Healgen Scientific,, LLC (2014) Summary page 5.
- K143187: Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card), Healgen Scientific,, LLC (2015) Summary page 5.
- K141647: Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip (Cassette, Cup, Dip Card), Healgen Scientific,, LLC (2014) Summary page 5.
- K140546: Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine Test, Healgen Scientific,, LLC (2014) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K150356
Methodology: https://510kreport.com/methodology