Cleared Traditional

K100588 - HUMAN IGA2 KIT FOR USE ON THE SPAPLUS

K100588 is the FDA 510(k) clearance for HUMAN IGA2 KIT FOR USE ON THE SPAPLUS by The Binding Site Group , Ltd.. It is a Class 2 Immunology device (product code CFN) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K100588 · The Binding Site Group , Ltd. · Immunology device
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Aug 2010
Decision
167d
Days
Class 2
Risk

K100588 is an FDA 510(k) clearance for the HUMAN IGA2 KIT FOR USE ON THE SPAPLUS. Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Los Angeles, US). The FDA issued a Cleared decision on August 16, 2010 after a review of 167 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Group , Ltd. devices

Submission Details

510(k) Number K100588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2010
Decision Date August 16, 2010
Days to Decision 167 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
63d slower than avg
Panel avg: 104d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFN Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CFN Method, Nephelometric, Immunoglobulins (g, A, M)

All 51
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