Cleared Traditional

K082129 - HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082129 · The Binding Site, Ltd. · Immunology device
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Feb 2009
Decision
196d
Days
Class 2
Risk

K082129 is an FDA 510(k) clearance for the HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER. Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on February 10, 2009 after a review of 196 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.

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Submission Details

510(k) Number K082129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2008
Decision Date February 10, 2009
Days to Decision 196 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 104d · This submission: 196d
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.