Cleared Traditional

K053073 - N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN

K053073 is the FDA 510(k) clearance for N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN by Dade Behring, Inc.. It is a Class 2 Immunology device (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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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

Submission Details

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
43d slower than avg
Panel avg: 104d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (DEB) and FDA review panel - the closest regulatory comparables to K053073.
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K896483 · Kallestad Diag, A Div. of Erbamont, Inc. · Dec 1989
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K812493 · Dako Corp. · Sep 1981
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K791340 · Beckman Instruments, Inc. · Aug 1979