# K062191: Dimension Vista System Drugs of Abuse Positive and Negative Controls, Models KC515 and KC516

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 21, 2006 after 21 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- 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 K950138 (1995). 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)
- K950138: Drugs of Abuse Controls, E.I. Dupont DE Nemours & Co., Inc. (1995) Summary page 3.

## Indications for use
The Dimension VistaTM System Drugs of Abuse Positive Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension Vista TM System. The Dimension VistaTM System Drugs of Abuse Negative Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METIL), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension VistaTM System.

Source page: https://510kreport.com/device/K062191
Methodology: https://510kreport.com/methodology