510(k) · Cleared
ClearedHealgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healgen Scientific,, LLC · DIS Enzyme Immunoassay, Barbiturate
Cleared on Apr 24, 2015 as substantially equivalent to K132812 (Ucp Biosciences, Inc., 2014) after a 30-day review. Its family tree reaches back 3 generations to 2009. 3 later devices descend from it.
- Decided
- Apr 24, 2015
- Review
- 30 days
- Class
- Class II
- Product code
- DIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K091588 (2009). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK091588 Ucp Home Drug Screening TestsUcp Biosciences, Inc. · 2009
- 2 generations backK130463 Ucp Home Drug Screening Test; Cards, CupsUcp Biosciences, Inc. · 2013
- 1 generation backK132812 Ucp Multi-Drug Test Key CupsUcp Biosciences, Inc. · 2014
- This deviceK150791 Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen…Healgen Scientific,, LLC · 2015
- Descendant · cites it directly · 0 of its ownK163704 Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip…Healgen Scientific,, LLC · 2017
- Descendant · cites it directly · 0 of its ownK153597 Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip…Healgen Scientific,, LLC · 2016
- Descendant · cites it directly · 0 of its ownK151642 Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip…Healgen Scientific,, LLC · 2015
Most influential descendants
Showing 3 of 3 · See all- K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC · 2017 · cites it directly0descendants
- K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC · 2016 · cites it directly0descendants
- K151642Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K091588 | Ucp Home Drug Screening Tests | Ucp Biosciences, Inc. | 2009 | — |
| −2 | K130463 | Ucp Home Drug Screening Test; Cards, Cups | Ucp Biosciences, Inc. | 2013 | — |
| −1 | K132812 | Ucp Multi-Drug Test Key Cups | Ucp Biosciences, Inc. | 2014 | — |
| 0 (this device) | K150791 | Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen… | Healgen Scientific,, LLC | 2015 | — |
| +1 | K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2017 | — |
| +1 | K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2016 | — |
| +1 | K151642 | Heagen 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 |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 DIS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K132812 | Ucp Multi-Drug Test Key CupsSummary page 5…Methadone Test System Toxicology DJG 21 CFR, 862.3650 Opiate Test System Toxicology 5. Predicate Devices: k132812 UCP Multi-Drug Test Key Cups 6. Intended Use / Indications for Use Healgen Secobarbital Test is an immunochromatographic a… | 2014 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K163704 (Healgen Scientific,, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132812.
How does its category compare?
All DIS devicesDIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DIS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIS
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIS
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIS
1in 2018
MAUDE reports naming product code DIS, 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 | 3 | 331 | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 29 | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (415 words)
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.
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/K150791 · printed Nov 5, 2026
Cite this page
510(k) Report. “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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150791
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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