HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS— 510(k) K123256

Clearance details

Applicant

The Binding Site Group , Ltd.

Product code

Code DEM

Device class

Class 2

Regulation

21 CFR 866.5130

Advisory panel

Immunology

Date received

2012-10-18

Decision date

2013-07-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Birmingham, GB

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• Z-0002-2018 — Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Ltd., Birmingham, UK. Product is designed for the quantitative in-vitro determination of Alpha-1-antitrypsin in human serum using the SPAPLUS turbidimetric analyser. The measurement of Alpha-1-antitrypsin aids in the diagnosis of several conditions including adult cirrhosis of the liver. In addition, Alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema. This test should be used in conjunction with other laboratory and clinical findings.Class II·Terminated·The Binding Site Group, Ltd.·20170823

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123256.