# K981814: ALBP

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jul 22, 1998 after 61 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K203530: Albumin BCP2 (2022), 0 descendants of its own

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

Source page: https://510kreport.com/device/K981814
Methodology: https://510kreport.com/methodology