# K993444: K-Assay Alpha-1 at

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Nov 24, 1999 after 43 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The K-ASSAY Alpha-1 AT Assay is intended to be used for the quantitative determination of Alpha-1-Antitrypsin in human serum by immunoturbidimetric assay. Measurement of Alpha-1-Antitrypsin aids in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, Alpha-1-Antitrypsin deficiency has been associated with pulmonary emphysema. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K993444
Methodology: https://510kreport.com/methodology