# K153597: Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card

- Pathway: 510(k) (Special)
- Applicant: Healgen Scientific,, LLC
- Decided: May 23, 2016 after 159 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: 8 generations back to K945610 (1995). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 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 6.
- K143187: Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card), Healgen Scientific,, LLC (2015) Summary page 6.
- K141647: Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip (Cassette, Cup, Dip Card), Healgen Scientific,, LLC (2014) Summary page 6.
- K140546: Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine Test, Healgen Scientific,, LLC (2014) Summary page 6.
- K150791: Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card), Healgen Scientific,, LLC (2015) Summary page 6.
- K150096: Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card), Healgen Scientific,, LLC (2015) Summary page 6.
- K151348: Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card), Healgen Scientific,, LLC (2015) Summary page 6.

## Indications for use
The 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, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, EDDP, Nortriptyline and Methadone in human urine at the cutoff concentrations of: Drug (identifier) Cut-off level Amphetamine 1000 ng/mL Oxazepam 300 ng/mL Cocaine 300 ng/mL Cannabinoids 50 ng/mL Methamphetamine 1000 ng/mL Morphine 300 or 2000 ng/mL Oxycodone 100 ng/mL Secobarbital 300 ng/mL Buprenorphine 10 ng/mL Methylenedioxymethamphetamine 500 ng/mL Phencyclidine 25 ng/mL Methadone 300 ng/mL EDDP 300 ng/mL Nortriptyline 1000 ng/mL Configurations 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 up to a maximum of 14 analytes. Only one cutoff concentration will be included per analyte per device. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized drug levels for Buprenorphine, Oxazepam, Secobarbital, Nortriptyline or Oxycodone in urine. 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/K153597
Methodology: https://510kreport.com/methodology