# K981758: ALBG

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 12, 1998 after 24 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K811194 (1981). 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)
- K811194: Hitachi 705 Automatic Blood Chemistry, Boehringer Mannheim Corp. (1981) Summary page 1.

## Most influential descendants
- K203248: Albumin BCG2 (2021), 0 descendants of its own

## Recalls of this device
- Mar 10, 2010 · Not classified · Z-1434-2012: Observed particulate matter in some reagent cartridges.

## Indications for use
The Albumin BCG assay is used for the quantitation of albumin in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Source page: https://510kreport.com/device/K981758
Methodology: https://510kreport.com/methodology