# K984494: Randox Albumin

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Mar 23, 1999 after 96 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- Recalls of this device: none
- 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.

## Indications for use
The Randox Albumin Test Kit is an in vitro diagnostic test reagent for the quantitative determination of albumin in serum. The method is based on the reaction of serum albumin with the indicator Bromocresol Green (BCG), to give a coloured complex which can be detected at 578nm. Measurement of albumin may be used in the treatment and diagnosis of hypoalbuminaemia due to liver disease, kidney disease, malnutrition or malabsorption and burns or dermatitis. This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K984494
Methodology: https://510kreport.com/methodology