Cleared Traditional

K052819 - VITROS CHEMISTRY PRODUCTS AAT REAGENT

K052819 is the FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS AAT REAGENT by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Immunology device (product code DEM) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K052819 · Ortho-Clinical Diagnostics, Inc. · Immunology device
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Dec 2005
Decision
80d
Days
Class 2
Risk

K052819 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE .... Classified as Alpha-1-antitrypsin, Antigen, Antiserum, Control (product code DEM), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 23, 2005 after a review of 80 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 Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K052819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2005
Decision Date December 23, 2005
Days to Decision 80 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
24d faster than avg
Panel avg: 104d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (DEM) and FDA review panel - the closest regulatory comparables to K052819.
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
K123256 · The Binding Site Group , Ltd. · Jul 2013
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
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