510(k) · Cleared
Recalled · Class II · 2020Etoh Flex Reagent Cartridge (DF22)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Cleared on Aug 24, 2007 as substantially equivalent to K904302 (E.I. Dupont DE Nemours & Co., Inc., 1990) and 1 other predicate after a 52-day review. Its family tree reaches back 1 generation to 1990. It has been recalled once.
- Decided
- Aug 24, 2007
- Review
- 52 days
- Class
- Class II
- Product code
- DIC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904302 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK904302 Dupont Dimension (R) Ethyl Alcohol (Alc) MethodE.I. Dupont DE Nemours & Co., Inc. · 1990
- This deviceK071811 Etoh Flex Reagent Cartridge (DF22)Dade Behring, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904302 | Dupont Dimension (R) Ethyl Alcohol (Alc) Method | E.I. Dupont DE Nemours & Co., Inc. | 1990 | — |
| 0 (this device) | K071811 | Etoh Flex Reagent Cartridge (DF22) | Dade Behring, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K904302 | Dupont Dimension (R) Ethyl Alcohol (Alc) MethodSummary page 1…The Dimension® ETOH Flex® reagent cartridge is substantially equivalent to the Dimension® ALC Flex® reagent cartridge (K904302) and to the Syva® Emit® II Plus Ethyl Alcohol Assay (K010960). H. Device Description:… | 1990 |
| * | K010960 | Emit II Plus Ethyl Alcohol Assay, Model OSR9K229Summary page 1…equivalent to the Dimension® ALC Flex® reagent cartridge (K904302) and to the Syva® Emit® II Plus Ethyl Alcohol Assay (K010960). H. Device Description: The Dimension® ETOH Flex® reagent cartridge is a prepackaged in… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2020 | Class II | Z-1599-2020 | Under Investigation by firm | The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K904302.
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. 2007, 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 ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl
alcohol in human serum, plasma and urine. Ethyl alcohol test results may be used in the
diagnosis and treatment of alcohol intoxication and poisoning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071811: Etoh Flex Reagent Cartridge (DF22).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071811
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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