510(k) · Cleared
ClearedEthanol-L3K Assay, Catalogue Number 273-30, 273-17
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Chemicals, Ltd. · DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Cleared on Jan 18, 2000 after a 61-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 18, 2000
- Review
- 61 days
- Class
- Class II
- Product code
- DIC
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
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.
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?
For the quantitative determination of ethanol in serum. For IN VITRO diagnostic use. Ethanol (ethyl alcohol) is the most common toxic substance involved in medical-legal cases. Ethanol consumption is often a factor in all types of accidents and ethanol poisoning can be fatal. Ethanol testing of comatose patients aids in the differential diagnosis of the cause of the coma. (1) Early methods for ethanol analysis depended on separation of the ethanol from…
Read the full statement (153 words)
For the quantitative determination of ethanol in serum. For IN VITRO diagnostic use.
Ethanol (ethyl alcohol) is the most common toxic substance involved in medical-legal cases. Ethanol consumption is often a factor in all types of accidents and ethanol poisoning can be fatal. Ethanol testing of comatose patients aids in the differential diagnosis of the cause of the coma. (1)
Early methods for ethanol analysis depended on separation of the ethanol from the specimen. The method described here is an enzymatic procedure which does not require separation and is rapid and easily automated. This method is based on the first enzymatic method described by Bonnichsen and Theorelle (2) and later modified by other authors. (3) However, the current method is unique in that an aldehyde trap is no longer necessary in order to drive the reaction to completion. This is accomplished by the use of a co-factor with a high oxidizing potential. (4)
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993920: Ethanol-L3K Assay, Catalogue Number 273-30, 273-17.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993920
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026