# K090939: Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical, Models 04590856 190, 04500873 190

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jun 18, 2009 after 76 days
- Product code: DKB (Calibrators, Drug Mixture)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K060429 (2006). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031775: Preciset Dat Plus I Calibrators, Roche Diagnostics Corp. (2003)
- K033306: Preciset Dat Plus II and Cfas Dat Qualitative Plus Calibrators, Roche Diagnostics Corp. (2003) Summary page 2.
- K080183: Control Set Dat I, Contrl Set Dat II, Control Set Dat Iii, Control Set Amphetamine 1000 and Control Set Amphetamine 500, Roche Diagnostics Corp. (2008) Summary page 2.

## Indications for use
The C.f.a.s. DAT Qualitative Plus Clinical calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. The Control Set DAT Clinical is for use as an assayed control in the Roche test system for qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K090939
Methodology: https://510kreport.com/methodology