# K141647: Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip (Cassette, Cup, Dip Card)

- Pathway: 510(k) (Traditional)
- Applicant: Healgen Scientific,, LLC
- Decided: Jul 17, 2014 after 28 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K050186 (2005). 2 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052115: First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy, First Check Diagnostics, LLC (2005) Summary page 3.

## Most influential descendants
- K163704: Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card (2017), 0 descendants of its own
- K153597: Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (2016), 0 descendants of its own
- K151642: Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (2015), 0 descendants of its own
- K150356: Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (2015), 0 descendants of its own

## Indications for use
Healgen COC One Step Cocaine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. 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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use. Healgen MOP One Step Morphine Test is an immunochromatographic assay for the qualitative determination of morphine in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. 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 is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Source page: https://510kreport.com/device/K141647
Methodology: https://510kreport.com/methodology