Preciset Dat Plus I, Preciset Dat Plus Ii And Cfas Dat Qualitative Plus Calibra…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060645 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)
Preciset DAT Plus I, Preciset DAT Plus II and CFAS DAT Qualitative Plus Calibrators are calibrators, drug mixture, designed for the qualitative calibration of Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. Preciset DAT Plus I consists of liquid, ready-to-use calibrators with 6 levels, Calibrators 1-6.
These calibrators are supplied as liquid, ready-to-use materials and are intended for use in clinical laboratory settings. They are classified as Class II devices under regulation number 862.3200 with product code DKB and were cleared via the FDA 510(k) process under K060645.
Frequently asked questions
What is the intended use of Preciset DAT Plus I, II and CFAS DAT Qualitative Plus Calibrators?
These calibrators are designed for the qualitative calibration of Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers, ensuring accurate test results by establishing a known reference point for the assay's qualitative readout.
How are Preciset DAT Plus calibrators supplied and prepared for use?
Preciset DAT Plus I consists of liquid, ready-to-use calibrators with six levels (Calibrators 1-6), requiring no preparation or reconstitution before use, which simplifies workflow and reduces the risk of preparation errors in the clinical laboratory.
Are Preciset DAT Plus calibrators intended for single-use or multiple uses?
As liquid, ready-to-use calibrators intended for qualitative calibration, these materials are designed for single-use per calibration event to prevent contamination and ensure consistent performance, though the number of uses per vial may depend on the laboratory's specific protocol and stability data.
What regulatory pathway was used for the clearance of Preciset DAT Plus calibrators?
Preciset DAT Plus I, II and CFAS DAT Qualitative Plus Calibrators were cleared via the FDA 510(k) process under submission number K060645, demonstrating substantial equivalence to a legally marketed predicate device for the same intended use.
What classification and product code apply to Preciset DAT Plus calibrators under FDA regulations?
These calibrators are classified as Class II medical devices under regulation number 862.3200 with product code DKB, which covers calibrators, drug mixture, for use in clinical toxicology testing systems.
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 I, Preciset Dat Plus Ii and Cfas Dat Qualitative Plus ..., PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS… - FDA.report, Preciset Dat Plus I, Preciset Dat Plus Ii and Cfas Dat Qualitative Plus ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060645 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K060645 24 fields · synced Sep 27, 2026