Cleared Traditional

K031857 - ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY

K031857 is an FDA 510(k) clearance for ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY, manufactured by Bayer Diagnostics Corp.. The device is a Class 2 Chemistry device with product code DEM cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K031857 · Bayer Diagnostics Corp. · Chemistry device
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Sep 2003
Decision
80d
Days
Class 2
Risk

K031857 is an FDA 510(k) clearance for the ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY. Classified as Alpha-1-antitrypsin, Antigen, Antiserum, Control (product code DEM), Class II - Special Controls.

Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on September 4, 2003 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5130 - the FDA in vitro diagnostics and chemistry 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 Bayer Diagnostics Corp. devices

FDA 510(k) Submission Details - K031857

510(k) Number K031857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2003
Decision Date September 04, 2003
Days to Decision 80 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 88d · This submission: 80d
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 Chemistry 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 K031857.
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
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
TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY
K972640 · Boehringer Mannheim Corp. · Jan 1998