# K093732: Advia Chemistry Drug Calibrator I Model 10376770

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Mar 22, 2010 after 108 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011035 (2001). 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)
- K011035: Dimension Drug Calibrator, Model DC22B, Dade Behring, Inc. (2001) Summary page 1.

## Recalls of this device
- Jan 19, 2015 · Class II · Z-1321-2015: Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 (PHNY_2) and Phenobarbital 2 (PHNB_2) assays which 

## Indications for use
For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PH-NY_2), and Th'leophylline_2 (THEo_2) methods on the ADVIA Chemistry Systems

Source page: https://510kreport.com/device/K093732
Methodology: https://510kreport.com/methodology