On*site Alcohol
510(k) K923337
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK923337 | Date12 Jan 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DML
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3040
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The On-Site Alcohol is a specific reagent for the enzyme method used in the quantitative determination of alcohol (ethanol) levels in biological samples. Classified as a Nad-Nadh device under the Specific Reagent for Alcohol Enzyme Method nomenclature, it is designed for clinical toxicology applications, enabling rapid and accurate detection of alcohol in patient specimens.
This device is supplied as a single-use reagent intended for use in clinical laboratories or toxicology testing settings. It is not sterile and is classified under FDA regulation 862.3040 as a Class II device, with clearance via a Traditional 510(k) pathway. Storage and handling follow standard laboratory protocols for enzyme-based reagents, and its use is authorized under the DML product code for diagnostic reagents.
Other devices from Toxi-Lab, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the On-Site Alcohol reagent used for?
The On-Site Alcohol reagent is specifically designed for the enzyme method used in quantitative alcohol (ethanol) testing in biological samples. It is intended for clinical toxicology applications, enabling laboratories to rapidly and accurately measure alcohol levels in patient specimens, which is critical for diagnosing alcohol intoxication or monitoring withdrawal cases.
Is the On-Site Alcohol reagent sterile?
No, the On-Site Alcohol reagent is not sterile. It is supplied as a single-use reagent intended for use in clinical laboratories or toxicology testing settings, where standard laboratory protocols for non-sterile enzyme-based reagents apply. Sterility is not required for this type of diagnostic reagent under FDA regulations.
How is the On-Site Alcohol reagent supplied and stored?
The On-Site Alcohol reagent is supplied as a single-use reagent, meaning each unit is intended for one-time use in testing. Storage should follow standard laboratory protocols for enzyme-based reagents, which typically involve keeping the reagent in a cool, dry place away from direct sunlight and extreme temperatures. Always refer to the manufacturer’s instructions for specific storage guidelines.
What regulatory pathway was used for FDA clearance of the On-Site Alcohol reagent?
The On-Site Alcohol reagent received FDA clearance through the Traditional 510(k) pathway, which demonstrates that it is substantially equivalent to a legally marketed predicate device. This clearance was granted under the DML product code for diagnostic reagents and is classified as a Class II device under FDA regulation 862.3040, indicating moderate regulatory oversight due to its role in clinical toxicology.
Can the On-Site Alcohol reagent be reused?
No, the On-Site Alcohol reagent is explicitly designed for single-use only. Reusing it could compromise accuracy, reliability, and potentially introduce contamination or cross-sample errors, which are critical concerns in clinical toxicology testing. Always adhere to the manufacturer’s instructions to ensure valid and safe results.