Cleared Traditional

K042579 - BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT

K042579 is an FDA 510(k) clearance for BINDAZYME HUMAN ASCA IGG AND IGA EIA DI..., manufactured by The Binding Site. The device is a Class 2 Immunology device with product code NBT cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K042579 · The Binding Site · Immunology device
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Optimized for regulatory review, auditing and printing
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.

View all The Binding Site devices

FDA 510(k) Submission Details - K042579

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.

NBT Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NBT Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)

Devices cleared under the same product code (NBT) and FDA review panel - the closest regulatory comparables to K042579.
TECHLAB ASCA-CHEK
K051927 · Techlab, Inc. · Apr 2006
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
K032850 · Immco Diagnostics, Inc. · Mar 2004
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
K032860 · Immco Diagnostics, Inc. · Mar 2004
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
K000733 · Inova Diagnostics, Inc. · May 2001
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
DEN000007 · Inova Diagnostics, Inc. · Aug 2000