# K090900: Advia Chemistry Drug Calibrator II, Model 10376771

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jun 1, 2009 after 61 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 1.

## Indications for use
The ADVIA Chemistry TDM DRUG Calibrator II is for in vitro diagnostic use in the calibration of Carbamazepine_2 (CARB_2), Gentamicin_2 (GENT 2), Tobramycin_2 (TOBR 2), Valproic Acid 2 (VPA 2), and Vancomycin_2 (VANC 2) methods on the ADVIA Chemistry Systems.

Source page: https://510kreport.com/device/K090900
Methodology: https://510kreport.com/methodology