# K062121: Dimension Vista System Drug 2 Calibrator (Drug 2 Cal - KC420)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 25, 2006 after 31 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: 4 generations back to K891093 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033809: Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49D, Dade Behring, Inc. (2004) Summary page 2.

## Indications for use
The DRUG 2 CAL is an in vitro diagnostic product for the calibration of acetaminophen (ACTM), carbamazepine (CRBM), digitoxin (DGTX), gentamicin (GENT), lidocaine (LIDO), N-acetylprocainamide (NAPA), procainamide (PROC), tobramycin (TOBR), valproic acid (VALP), and vancomycin (VANC) methods on the Dimension VistaTM System.

Source page: https://510kreport.com/device/K062121
Methodology: https://510kreport.com/methodology