# K123256: Human Alpha-1 Antitrypsin Kit Spaplus

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Jul 3, 2013 after 258 days
- Product code: DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5130
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Aug 23, 2017 · Class II · Z-0002-2018: The high control for the kit is recovering low and may be out of range for assigned values.

## Indications for use
The Human al-antitrypsin Kit for use on SPAPLUS is designed for the quantitative in vitro determination of al-antitrypsin in human serum using the SPApius turbidimetric analyzer. The measurement of al-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, al-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K123256
Methodology: https://510kreport.com/methodology