# K021393: Preciset Dat Plus

- Pathway: 510(k) (Traditional)
- Applicant: Quantimetrix Corp.
- Decided: Jun 13, 2002 after 42 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Emit Calibrators/controls manufactured by Syva Company: named in the summary without a submission number

## Indications for use
The Preciset DAT Plus calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K021393
Methodology: https://510kreport.com/methodology