Cleared Traditional

K042579 - BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT (FDA 510(k) Clearance)

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

K042579 · The Binding Site · Immunology device
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Jul 2005
Decision
309d
Days
Class 2
Risk

K042579 is an FDA 510(k) clearance for the BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT. Classified as Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) (product code NBT), Class II - Special Controls.

Submitted by The Binding Site (Santa Monica, US). The FDA issued a Cleared decision on July 28, 2005 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5785 - 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.

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Submission Details

510(k) Number K042579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2004
Decision Date July 28, 2005
Days to Decision 309 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 104d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBT Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5785
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.