Cleared Traditional

HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS

K123256 · The Binding Site Group , Ltd. · Immunology
Jul 2013
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K123256 is an FDA 510(k) clearance for the HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS, a Alpha-1-antitrypsin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEM), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on July 3, 2013, 258 days after receiving the submission on October 18, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5130.

Submission Details

510(k) Number K123256 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2012
Decision Date July 03, 2013
Days to Decision 258 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DEM — Alpha-1-antitrypsin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5130

Similar Devices — DEM Alpha-1-antitrypsin, Antigen, Antiserum, Control

All 29
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
K063610 · Dade Behring, Inc. · Jan 2007
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
K053072 · Dade Behring, Inc. · Mar 2006
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III
K052819 · Ortho-Clinical Diagnostics, Inc. · Dec 2005
QUANTIA A1-AT
K050596 · Biokit, S.A. · May 2005
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
K031857 · Bayer Diagnostics Corp. · Sep 2003
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
K011663 · The Binding Site, Ltd. · Jul 2001