Cleared Traditional

K140664 - HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ...

K140664 is the FDA 510(k) clearance for HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ... by The Binding Site Group , Ltd.. It is a Class 2 Immunology device (product code DEB) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K140664 · The Binding Site Group , Ltd. · Immunology device
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Apr 2014
Decision
29d
Days
Class 2
Risk

K140664 is an FDA 510(k) clearance for the HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS. Classified as Alpha-2-macroglobulin, Antigen, Antiserum, Control (product code DEB), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on April 16, 2014 after a review of 29 days - a notably fast clearance cycle.

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: 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 The Binding Site Group , Ltd. devices

Submission Details

510(k) Number K140664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2014
Decision Date April 16, 2014
Days to Decision 29 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
75d faster than avg
Panel avg: 104d · This submission: 29d
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 9
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