Cleared Traditional

K050596 - QUANTIA A1-AT

K050596 is an FDA 510(k) clearance for QUANTIA A1-AT, manufactured by Biokit, S.A.. The device is a Class 2 Immunology device with product code DEM cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K050596 · Biokit, S.A. · Immunology device
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May 2005
Decision
66d
Days
Class 2
Risk

K050596 is an FDA 510(k) clearance for the QUANTIA A1-AT. Classified as Alpha-1-antitrypsin, Antigen, Antiserum, Control (product code DEM), Class II - Special Controls.

Submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on May 13, 2005 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biokit, S.A. devices

FDA 510(k) Submission Details - K050596

510(k) Number K050596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2005
Decision Date May 13, 2005
Days to Decision 66 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 105d · This submission: 66d
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 K050596.
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
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
K-ASSAY ALPHA-1 AT
K993444 · Kamiya Biomedical Co. · Nov 1999