Cleared Traditional

K913666 - ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT

K913666 is an FDA 510(k) clearance for ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TE..., manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with product code DEM cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K913666 · The Binding Site, Ltd. · Immunology device
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Dec 1991
Decision
112d
Days
Class 2
Risk

K913666 is an FDA 510(k) clearance for the ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT. Classified as Alpha-1-antitrypsin, Antigen, Antiserum, Control (product code DEM), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 112 days - within the typical 510(k) review window.

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, Ltd. devices

FDA 510(k) Submission Details - K913666

510(k) Number K913666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date December 09, 1991
Days to Decision 112 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
7d slower than avg
Panel avg: 105d · This submission: 112d
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 K913666.
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
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K875281 · Kallestad Diag, A Div. of Erbamont, Inc. · Feb 1988