Roche Reagent for Ethanol

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K913125 ↗

FDA Product Code

DIC

Device Class

Class II

Regulation

21 CFR Part 862.3040

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What types of biological samples can this reagent measure ethanol in, and how is it used clinically?

  This reagent is designed for quantitative measurement of ethanol concentrations specifically in human serum, plasma, and urine samples. It uses the enzyme method with alcohol dehydrogenase, making it suitable for clinical toxicology applications, such as assessing alcohol intoxication or monitoring ethanol levels in patients.

• Is this reagent compatible with any specific laboratory equipment, and how is it supplied?

  The reagent is exclusively intended for use on Roche/Hitachi cobas c systems, including the cobas c 503 analyzer. It is supplied as a single-use diagnostic reagent, adhering to standard in vitro diagnostic reagent protocols for storage and handling.

• How should this reagent be stored, and is it intended for single-use only?

  While the exact storage instructions are not detailed here, this reagent follows standard in vitro diagnostic reagent protocols, which typically require refrigeration and protection from light. Yes, it is explicitly designed for single-use only, ensuring accuracy and preventing cross-contamination.

• What regulatory pathway was followed for this reagent’s clearance, and what does that mean for its use?

  This reagent received FDA clearance under a 510(k) submission (K913125), classified as substantially equivalent to a predicate device. This means it was reviewed for safety and performance against an existing, cleared device and is authorized for clinical toxicology use, specifically for measuring ethanol in serum, plasma, and urine.