# K062162: Dimension Vista System Drugs of Abuse Calibrator (Udat Cal - KC510)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 14, 2006 after 48 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 K993755 (1999). 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)
- K993755: Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5, Syva Co. (1999) Summary page 2.

## Indications for use
The UDAT CAL is an in vitro diagnostic product for the calibration of Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Methaqualone (MTQ), Opiates (OPI), Phencyclidine (PCP), Propoxyphene (PRX), and Cannabinoids (THU) methods on the Dimension Vista TM System.

Source page: https://510kreport.com/device/K062162
Methodology: https://510kreport.com/methodology