# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Healgen Scientific,, LLC
- Decided: Apr 24, 2015 after 30 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- 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 K091588 (2009). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132812: Ucp Multi-Drug Test Key Cups, Ucp Biosciences, Inc. (2014) Summary page 5.

## 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

## Indications for use
Healgen Secobarbital Test is an immunochromatographic assay for the qualitative determination of Secobarbital 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 may yield preliminary positive results even when the prescription drug Secobarbital is ingested, at prescribed doses: it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Secobarbital in urine. 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 prescription and for over-the-counter use. Healgen Buprenorphine Test is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at a Cut-Off concentration of 10 ng/mL.. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test may yield preliminary positive results even when the prescription drug Buprenorphine is ingested, at prescribed doses: it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Buprenorphine in urine. 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 prescription and for over-the-counter use. Healgen Methadone Test is an immunochromatographic assay for the qualitative determination of Methadone 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 prescription and for over-the-counter use.

Source page: https://510kreport.com/device/K150791
Methodology: https://510kreport.com/methodology