Cleared Traditional

K053073 - N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN

K053073 is an FDA 510(k) clearance for N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN, manufactured by Dade Behring, Inc.. The device is a Class 2 Immunology device with product code DEB cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K053073 · Dade Behring, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Mar 2006
Decision
147d
Days
Class 2
Risk

K053073 is an FDA 510(k) clearance for the N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN. Classified as Alpha-2-macroglobulin, Antigen, Antiserum, Control (product code DEB), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on March 28, 2006 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5620 - 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K053073

510(k) Number K053073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2005
Decision Date March 28, 2006
Days to Decision 147 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
42d slower than avg
Panel avg: 105d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEB Device Classification - Class 2, Special Controls

Product Code DEB Alpha-2-macroglobulin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5620
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 - DEB Alpha-2-macroglobulin, Antigen, Antiserum, Control

All 11
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