# K032461: Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Oct 3, 2003 after 53 days
- Product code: DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method)
- Device class: 2
- Regulation: 21 CFR 862.3040
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903152 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923783: Ethyl Alcohol Assay, Diagnostic Reagents, Inc. (1993) Summary page 1.
- K903152: Emit Ethyl Alcohol Calibrators and Controls, Syva Co. (1990) Summary page 4.

## Most influential descendants
- K181553: Immunalysis Ethyl Alcohol Enzyme Assay (2018), 0 descendants of its own

## Recalls of this device
- Jan 16, 2019 · Class III · Z-1253-2019: 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: 
- Jan 11, 2019 · Class III · Z-1256-2019: Shelf life of the product may be reduced due to degradation of the assay.

## Indications for use
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.

Source page: https://510kreport.com/device/K032461
Methodology: https://510kreport.com/methodology