# K974607: Randox Calcium

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Feb 2, 1998 after 54 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Dec 4, 2018 · Class II · Z-0839-2019: 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 Laboratories Limited Calcium Test Kit is an in vitro diagnostic reagent for the quantitative determination of calcium in human serum. This method is based on the interaction of calcium with Arsenazo III to form a coloured complex which can be measured at 650nm. The intensity of the final colour is directly proportional to the calcium concentration. Measurements of calcium are used in the diagnosis and treatment of parathyroid disease, malignant diseases with and without bone involvement, chronic renal failure and a variety of bone diseases. This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K974607
Methodology: https://510kreport.com/methodology