Cleared Traditional

K920005 - IL TEST ALPHA-1-ANTITRYPSIN (AAT)

K920005 is an FDA 510(k) clearance for IL TEST ALPHA-1-ANTITRYPSIN (AAT), manufactured by Instrumentation Laboratory CO. The device is a Class 2 Immunology device with product code DEM cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K920005 · Instrumentation Laboratory CO · Immunology device
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Optimized for regulatory review, auditing and printing
Jul 1992
Decision
209d
Days
Class 2
Risk

K920005 is an FDA 510(k) clearance for the IL TEST ALPHA-1-ANTITRYPSIN (AAT). Classified as Alpha-1-antitrypsin, Antigen, Antiserum, Control (product code DEM), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on July 29, 1992 after a review of 209 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.

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FDA 510(k) Submission Details - K920005

510(k) Number K920005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1992
Decision Date July 29, 1992
Days to Decision 209 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
104d slower than avg
Panel avg: 105d · This submission: 209d
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 K920005.
N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT
K965100 · Crestat Diagnostics, Inc. · Jul 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
K964766 · Beckman Instruments, Inc. · Apr 1997
VENTANA NEGATIVE CONTROL REAGENT
K931979 · Ventana Medical Systems, Inc. · Mar 1994
ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT
K913666 · The Binding Site, Ltd. · Dec 1991
SPQ(TM) ANTIBODY REAGENT SET II FOR AAT
K890415 · Atlantic Antibodies · Feb 1989
ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM
K882446 · Technicon Instruments Corp. · Jul 1988