510(k) · Cleared
ClearedAT Home Drug Test Models, 9308T and 9308X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phamatech, Inc. · DIS Enzyme Immunoassay, Barbiturate
Cleared on Dec 7, 2007 after a 338-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 7, 2007
- Review
- 338 days
- Class
- Class II
- Product code
- DIS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK070009 AT Home Drug Test Models, 9308T and 9308XPhamatech, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK103295 Quickscreen Cocaine 150 Screening TestPhamatech, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK153192 Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue…Chemtron Biotech, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK232736 Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug…Chemtron Biotech, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK252684 Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK181945 QuickScreen Pro Multi Drug Screening Test, Model 9395ZPhamatech, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K103295Quickscreen Cocaine 150 Screening TestPhamatech, Inc. · 2012 · cites it directly3descendants
- K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc. · 2016 · 2 generations on2descendants
- K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc. · 2023 · 3 generations on1descendant
- K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc. · 2026 · 4 generations on0descendants
- K181945QuickScreen Pro Multi Drug Screening Test, Model 9395ZPhamatech, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070009 | AT Home Drug Test Models, 9308T and 9308X | Phamatech, Inc. | 2007 | — |
| +1 | K103295 | Quickscreen Cocaine 150 Screening Test | Phamatech, Inc. | 2012 | — |
| +2 | K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug… | Chemtron Biotech, Inc. | 2016 | — |
| +3 | K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen… | Chemtron Biotech, Inc. | 2023 | — |
| +4 | K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | 2026 | — |
| +1 | K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395Z | Phamatech, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 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?
- Of its descendants, K103295 (Phamatech, Inc., 2012) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DIS devicesDIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 | — |
https://510kreport.com/device/K070009 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070009: AT Home Drug Test Models, 9308T and 9308X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070009
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026