Cleared Traditional

K123256 - HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS

K123256 is an FDA 510(k) clearance for HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS, manufactured by The Binding Site Group , Ltd.. The device is a Class 2 Immunology device with product code DEM cleared through the Traditional 510(k) pathway after a 258-day FDA review.

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

K123256 is an FDA 510(k) clearance for the HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS. Classified as Alpha-1-antitrypsin, Antigen, Antiserum, Control (product code DEM), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on July 3, 2013 after a review of 258 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5130 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all The Binding Site Group , Ltd. devices

FDA 510(k) Submission Details - K123256

510(k) Number K123256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 105d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEM Device Classification - Class 2, Special Controls

Product Code DEM Alpha-1-antitrypsin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DEM Alpha-1-antitrypsin, Antigen, Antiserum, Control

All 25
Devices cleared under the same product code (DEM) and FDA review panel - the closest regulatory comparables to K123256.
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