# K981457: ALBP

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Mfg., Inc.
- Decided: May 27, 1998 after 34 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: 1 generation back to K844426 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844426: Albumin BCP, Boehringer Mannheim Corp. (1985) Summary page 1.

## Indications for use
The Albumin BCP assay is used for the quantitation of albumin in human serum. Albumin BCP measurements are used in the diagnosis and treatment of kidney disease and liver disease.

Source page: https://510kreport.com/device/K981457
Methodology: https://510kreport.com/methodology