# K033306: Preciset Dat Plus II and Cfas Dat Qualitative Plus Calibrators

- Pathway: 510(k) (Abbreviated)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 15, 2003 after 62 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: 1 generation back to K951595 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 1.

## Most influential descendants
- K090939: Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical, Models 04590856 190, 04500873 190 (2009), 0 descendants of its own
- K060645: Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative Plus Calibrators (2006), 0 descendants of its own

## Indications for use
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/K033306
Methodology: https://510kreport.com/methodology