# K203530: Albumin BCP2

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Ireland Diagnostics Division
- Decided: Mar 18, 2022 after 471 days
- Product code: CJW (Bromcresol Purple 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
Longest line of descent: 2 generations back to K844426 (1985). 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)
- K981814: ALBP, Abbott Laboratories (1998) Summary page 5.

## Indications for use
The Albumin BCP2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System. The Albumin BCP2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Source page: https://510kreport.com/device/K203530
Methodology: https://510kreport.com/methodology