# K083386: Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N 02189915 (70 ML Fill)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Apr 2, 2009 after 136 days
- Product code: CJY (Azo Dye, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- 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 K991576 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991576: Additional Assays for the Bayer Advia 1650 Chemistry System, Bayer Corp. (1999) Summary page 1.

## Most influential descendants
- K182042: Randox Calcium (Ca) (2018), 0 descendants of its own

## Recalls of this device
- Feb 9, 2022 · Class II · Z-0928-2022: Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.

## Indications for use
For in vitro diagnostic use in the quantitative determination of calcium in human serum, plasma, and urine on the ADVIA Chemistry systems. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal failure, and tetany

Source page: https://510kreport.com/device/K083386
Methodology: https://510kreport.com/methodology