# K011663: Minineph a-1 Antitrypsin Antiserum, High and Low Serum Controls

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Jul 30, 2001 after 62 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
This assay is designed for the in vitro meagurement of human a-1 antitrypsin in serum using the Minineph®, as an aid in the diagnosis of several conditions, including juvenile and adult cirrhosis of the liver. In addition, a-1 antitrypsin deficiency has been associated with pulmonary emphysema.

Source page: https://510kreport.com/device/K011663
Methodology: https://510kreport.com/methodology