510(k) · Cleared
ClearedMission Saliva Alcohol Test Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Cleared on Aug 6, 2010 as substantially equivalent to K894001 (Enzymatics C/O Burditt,Bowles,Radzius & Ruberry, 1990) after a 231-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Aug 6, 2010
- Review
- 231 days
- Class
- Class II
- Product code
- DIC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894001 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK894001 Saliva Alcohol TestEnzymatics C/O Burditt,Bowles,Radzius & Ruberry · 1990
- This deviceK093879 Mission Saliva Alcohol Test StripACON Laboratories, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK121247 Alco-ScreenChematics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK111206 Teco Diagnostics Saliva Alcohol TestTeco Diagnostics · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894001 | Saliva Alcohol Test | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | 1990 | — |
| 0 (this device) | K093879 | Mission Saliva Alcohol Test Strip | ACON Laboratories, Inc. | 2010 | — |
| +1 | K121247 | Alco-Screen | Chematics, Inc. | 2013 | — |
| +1 | K111206 | Teco Diagnostics Saliva Alcohol Test | Teco Diagnostics | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 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 DIC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DIC device
- #1 K250609 Sober Self-Testscore 10.3 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K894001 | Saliva Alcohol TestSummary page 2…ase, specific reagent Medical Specialty: Toxicology Predicate Device: QED Al 5O Saliva Alcohol Test Orasure Technologies Inc., Bethlehem, PA 18018 5 10O(k) Number: K894001 Description: The Mission Saliva Alcohol Test Strip is a screening test used to semi-quantitatively measure alcohol in human s… | 1990 |
What descends from it? (2)
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?
How does its category compare?
All DIC devicesDIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DIC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DIC
Too few DIC 510(k)s in any year since 2007 to give a median.
Recalls per year · DIC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIC
3in 2025
MAUDE reports naming product code DIC, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 1 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Mission Saliva Alcohol Test Strip is a screening test used to semi-quantitatively measure alcohol in human saliva. The test strip indicates relative Blood Alcohol Concentration at 0.0%, 0.02%, 0.04%, 0.08%, and 0.30% cut-off levels. Results are used in the diagnosis of alcohol intoxication. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093879 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093879: Mission Saliva Alcohol Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093879
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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