Alcohol Test System FDA 510k Process
An Alcohol test system (IVD) refers to an In Vitro Diagnostic (IVD) medical device used to measure alcohol (ethanol) levels in biological samples, typically breath, saliva, blood, urine, or saliva. These systems are commonly used in medical, forensic, workplace, and personal testing settings.
Intended Use of Alcohol Test System
An alcohol test system is a device intended to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Alcohol Test System
Alcohol Test System Device Code and Regulation Number
| # | Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | DIC | Alcohol Dehydrogenase, Specific Reagent for Ethanol Enzyme Method | Alcohol Test System | 862.3040 | 2 |
| 2 | DML | NAD-NADH, a specific reagent for the alcohol enzyme method | |||
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (DIC)
Intended use: Assay is an in vitro diagnostic device for the quantitative analysis of ethyl alcohol (ethanol) in human saliva, urine, serum or plasma with automated clinical chemistry analyzers. The measurement of ethanol is used for the 2 diagnosis and treatment of alcohol intoxication and poisoning. This assay is calibrated against ethyl alcohol. This device is intended for prescription use only.
Device Description: It is based on the oxidation of ethyl alcohol to acetaldehyde by alcohol dehydrogenase (ADH) and nicotinamide adenine dinucleotide (NAD) reduced to NADH resulting in an absorbance change measured spectrophotometrically at 340nm. The concentration of ethanol in the sample is directly proportional to the ADH activity.
NAD-NADH, Specific Reagent for Alcohol Enzyme Method (DML)
Intended use: Ethyl alcohol assay is used to quantitatively analyse ethyl alcohol (ethanol) in human serum, plasma, or urine.
Device Description: A NAD-NADH-specific reagent for an alcohol enzyme method is an In Vitro Diagnostic (IVD) device used for the quantitative determination of alcohol (such as ethanol, methanol, or isopropanol) in biological samples. This enzymatic method relies on the oxidation of alcohol and the conversion of NAD⁺ (oxidized form) to NADH (reduced form), which is measured spectrophotometrically at 340 nm.
Performance Testing (Analytical) for Alcohol Test System
- Limit of Blank (LoB)/Limit of Detection (LoD)
- Limit of Quantitation (LoQ)
- Linearity/Recovery
- Precision
- Analytical specificity
- Analytical sensitivity
- Cross-Reactivity
- Within-run study
- correlation
- Interference
- Calibration Stability
- Method Comparison
The same is applicable for CE Marking under IVDR also.
Clinical Testing
Not Applicable for 510k submission and IVDR CE Marking