# K033246: Preciset Dat THC and Preciset Dat THC 20 Calibrators

- Pathway: 510(k) (Abbreviated)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 2, 2003 after 56 days
- Product code: DLJ (Calibrators, Drug Specific)
- 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 K961726 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961726: Abuscreen Online Cannabinoids Calibration Pack 20, Roche Diagnostic Systems, Inc. (1996) Summary page 1.

## Indications for use
The Preciset DAT THC calibrators are designed for the calibration of the Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers. The Preciset DAT THC 20 calibrators are designed for the calibration of the Roche assays for cannabinoids in human urine on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K033246
Methodology: https://510kreport.com/methodology