# K103701: Advia Chemistry Liquid Specific Protein Calibrators

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Feb 18, 2011 after 60 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 K031608 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031608: Randox Liquid Protein Calibrator, Randox Laboratories, Ltd. (2003) Summary page 1.
- K061056: Randox Liquid Protein Calibrator, Randox Laboratories, Ltd. (2006) Summary page 1.

## Indications for use
The ADVIA Chemistry Liquid Protein Calibrator is for in vitro diagnostic use in the calibration of AD VIA® Chemistry systems for the Alpha-Acid-G lycoprote in (AAG), Alpha-i -Antitrypsin (AAT), Ahti-streptolysin-0_2 (ASO -2), Complement 03 (C3), Complement 04 (04), Haptoglobin (HAPT), Immunoglobulin A-2 (IGA-2), Immunoglobulin G-2 (IGG&2), Immunoglobulin M-2 (IGM-2), Prealbumin (PREALB), Rheumatoid Factor (RF), Transferrin (TRF) methods

Source page: https://510kreport.com/device/K103701
Methodology: https://510kreport.com/methodology