# K031857: Advia Chemistry Alpha-1 Antitrypsin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Sep 4, 2003 after 80 days
- Product code: DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5130
- 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. The FDA summary names its predicate without a number.
- (no number) Roche Alpha-1-antitrypsin: named in the summary without a submission number

## Indications for use
The Buyer ADVIA Chemistry Alpha-1-antitrypsin method is an in vitro diagnostic device intended to quantitatively measure alpha-1-antitrypsin levels in human serum and plasma. Such measurements are used in the diagnosis of juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

Source page: https://510kreport.com/device/K031857
Methodology: https://510kreport.com/methodology