# K072204: Advia Chemistry Microalbumin Calibrators, _2 Calibrators

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Medical Solutions Diagnostics
- Decided: Oct 5, 2007 after 58 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K042243 (2004). 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)
- K042243: Microalbumin Multi-Calibrator Set, Diagnostic Chemicals, Ltd. (2004) Summary page 1.

## Indications for use
The ADVIA® Chemistry Microalbumin Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the ADVIA Chemistry Microalbumin method (this method is used for in vitro quantitation of albumin in urine). The ADVIA® Chemistry Microalbumin_2 Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the ADVIA Chemistry Microalbumin_2 method (this method is used for in vitro quantitation of albumin in urine).

Source page: https://510kreport.com/device/K072204
Methodology: https://510kreport.com/methodology