# K182042: Randox Calcium (Ca)

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Oct 23, 2018 after 85 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: 2 generations back to K991576 (1999). 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)
- K083386: Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N 02189915 (70 ML Fill), Siemens Healthcare Diagnostics (2009) Summary page 5.

## Recalls of this device
- Dec 4, 2018 · Class II · Z-0840-2019: Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results ma

## Indications for use
The Randox Calcium (Ca) device is intended for the quantitative in vitro determination of calcium concentration in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.

Source page: https://510kreport.com/device/K182042
Methodology: https://510kreport.com/methodology