# K060645: Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative Plus Calibrators

- Pathway: 510(k) (Abbreviated)
- Applicant: Roche Diagnostics Corp.
- Decided: May 30, 2006 after 81 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: 2 generations back to K951595 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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) Summary page 1.
- K033306: Preciset Dat Plus II and Cfas Dat Qualitative Plus Calibrators, Roche Diagnostics Corp. (2003) Summary page 1.

## Indications for use
The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K060645
Methodology: https://510kreport.com/methodology