Cleared Traditional

K120236 - TRANSFERRIN KIT FOR USE ON THE SPAPLUS

K120236 is the FDA 510(k) clearance for TRANSFERRIN KIT FOR USE ON THE SPAPLUS by The Binding Site Group , Ltd.. It is a Class 2 Immunology device (product code DDG) cleared through the Traditional 510(k) pathway after a 384-day FDA review.

K120236 · The Binding Site Group , Ltd. · Immunology device
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Feb 2013
Decision
384d
Days
Class 2
Risk

K120236 is an FDA 510(k) clearance for the TRANSFERRIN KIT FOR USE ON THE SPAPLUS. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on February 13, 2013 after a review of 384 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5880 - 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. Elevated predicate reliance profile. 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 Group , Ltd. devices

Submission Details

510(k) Number K120236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2012
Decision Date February 13, 2013
Days to Decision 384 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
280d slower than avg
Panel avg: 104d · This submission: 384d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDG Transferrin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5880
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 - DDG Transferrin, Antigen, Antiserum, Control

All 37
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