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Preciset Dat Plus Ii and Cfas Dat Qualitative Plus Calibrators

FDA 510(k)

Class II (US FDA 510(k))

510(k) K033306

by Roche Diagnostics Corp.

Identifiers

510(k) Number
K033306 FDA 510(k)
FDA Product Code
DKB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3200 FDA 510(k)
Regulation Number
862.3200 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Preciset Dat Plus Ii and Cfas Dat Qualitative Plus Calibrators are drug mixture calibrators designed for use on automated clinical chemistry analyzers. These products are indicated for the calibration of Roche drugs of abuse assays in human urine samples.

The Cfas Dat Qualitative Plus provides single-level calibration for a seven-drug mixture, while the Preciset Dat Plus Ii provides up to six concentration levels for quantitative calibration. These devices are intended for use in clinical laboratories by laboratory technicians and have received FDA 510(k) clearance.

Frequently asked questions

What are the Preciset DAT Plus II and CFAS DAT Qualitative Plus calibrators used for?

These calibrators are intended for use in clinical laboratories to calibrate Roche drugs of abuse assays. They are specifically designed to be used with automated clinical chemistry analyzers when testing human urine samples.

What is the difference between the two calibrator types?

The CFAS DAT Qualitative Plus provides a single-level calibration for a seven-drug mixture. In contrast, the Preciset DAT Plus II is designed for quantitative calibration and provides up to six different concentration levels.

Who is the intended user for these calibrators?

These devices are intended for use by laboratory technicians within a clinical laboratory setting to ensure the accuracy of drug testing procedures on automated analyzers.

What is the regulatory status of these calibrators?

These products have received FDA 510(k) clearance, which indicates that they have been reviewed and found to be substantially equivalent to legally marketed predicate devices for their intended use in clinical toxicology.

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: Preciset Dat Plus Ii and Cfas Dat Qualitative Plus Calibrators (K033306 ..., Preciset Dat Plus I, Preciset Dat Plus Ii and Cfas Dat Qualitative Plus ..., K033306 FDA 510(k) - PRECISET DAT PLUS II AND CFAS DAT QUALI...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA 510(k) K033306 24 fields · synced Sep 24, 2026