510(k) · Cleared
Recalled · Class III · 2019Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Cleared on Oct 3, 2003 as substantially equivalent to K923783 (Diagnostic Reagents, Inc., 1993) and 1 other predicate after a 53-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Oct 3, 2003
- Review
- 53 days
- Class
- Class II
- Product code
- DIC
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K903152 (1990). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK903152 Emit Ethyl Alcohol Calibrators and ControlsSyva Co. · 1990
- This deviceK032461 Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221Lin-Zhi International, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK181553 Immunalysis Ethyl Alcohol Enzyme AssayImmunalysis Corporation · 2018
Most influential descendants
Showing 1 of 1 · See all- K181553Immunalysis Ethyl Alcohol Enzyme AssayImmunalysis Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903152 | Emit Ethyl Alcohol Calibrators and Controls | Syva Co. | 1990 | — |
| 0 (this device) | K032461 | Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221 | Lin-Zhi International, Inc. | 2003 | — |
| +1 | K181553 | Immunalysis Ethyl Alcohol Enzyme Assay | Immunalysis Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K923783 | Ethyl Alcohol AssaySummary page 1…nternational, Inc.’s Ethyl Alcohol Enzymatic Assay is substantially equivalent to the Ethyl Alcohol Assay (By DRVMicrogenics Corp.), cleared under premarket notification K923783. LZI’s Ethyl Alcohol Enzymatic Assay is identical or similar to its predicate in terms of intended use, method principle, device… | 1993 |
| * | K903152 | Emit Ethyl Alcohol Calibrators and ControlsSummary page 4…s and Controls are substantially equivalent to EMIT Ethyl Alcohol Calibrators and Controls ( S p a Co., now Dade Behring Limited), cleared under premarket notifications (K903 152). Device Description Ethyl Alcohol Calibrators and Controls are aqueous phosphate buffer-based liquid, and ready to use. These C… | 1990 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181553 | Immunalysis Ethyl Alcohol Enzyme Assay | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2019 | Class III | Z-1253-2019 | Nonconforming Material/Component | Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the end of shelf life. |
| Jan 16, 2019 | Class III | Z-1252-2019 | Nonconforming Material/Component | |
| Jan 11, 2019 | Class III | Z-1256-2019 | Material/Component Contamination | Shelf life of the product may be reduced due to degradation of the assay. |
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.
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 Ethyl Alcohol Enzymatic Assay is a homogeneous enzymatic assay with 0 and 100 mg/dL (0.1%) alcohol calibrators. The assay is intended for use in the quantitative analyses of ethyl alcohol in human urine, serum or plasma. The assay is designed for professional use with a number of automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning. The Ethyl Alcohol…
Read the full statement (129 words)
The Ethyl Alcohol Enzymatic Assay is a homogeneous enzymatic assay with 0 and 100 mg/dL (0.1%) alcohol calibrators. The assay is intended for use in the quantitative analyses of ethyl alcohol in human urine, serum or plasma. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.
The Ethyl Alcohol Calibrators are intended for in vitro diagnostic use for the calibration of the Ethyl Alcohol Enzymatic Assay to determine the ethyl alcohol concentration in human urine, serum or plasma.
The Ethyl Alcohol Controls are intended for in vitro diagnostic use for the validation of the Ethyl Alcohol Enzymatic Assay to determine ethyl human urine, serum or plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032461: Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032461
Report an extraction error
Are you the manufacturer?
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