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ONLINE DAT Benzodiazepines II

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221765

by Roche Diagnostics

Identifiers

510(k) Number
K221765 FDA 510(k)
FDA Product Code
JXM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3170 FDA 510(k)
Regulation Number
862.3170 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ONLINE DAT Benzodiazepines II is an enzyme immunoassay for the qualitative and semiquantitative detection of benzodiazepines in human serum, plasma, and urine. This in vitro diagnostic test identifies benzodiazepines at cutoff concentrations of 100 ng/mL, 200 ng/mL, and 300 ng/mL, providing preliminary analytical results for clinical toxicology assessment.

This device is designed for use on Roche/Hitachi cobas c systems and is intended for laboratory settings. Supplied as a single-use reagent, it requires no sterilization beyond manufacturer packaging. The test results are semiquantitative, enabling laboratories to evaluate assay performance as part of quality control. Authorized under FDA 510(k) clearance (K221765), it adheres to regulatory standards for Class II medical devices (862.3170)

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BNZ2, ONLINE DAT Benzodiazepines II - Roche Diagnostics USA, BNZ2, ONLINE DAT Benzodiazepines II - Roche Diagnostics USA, Roche Diagnostics Cobas® ONLINE DAT Benzodiazepines II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Roche Diagnostics

Sources (1)

  • FDA 510(k) K221765 24 fields · synced Sep 20, 2026