Cleared Traditional

K032850 - IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ...

K032850 is an FDA 510(k) clearance for IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ..., manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code NBT cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K032850 · Immco Diagnostics, Inc. · Immunology device
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Mar 2004
Decision
188d
Days
Class 2
Risk

K032850 is an FDA 510(k) clearance for the IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG). Classified as Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) (product code NBT), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on March 18, 2004 after a review of 188 days - an extended review cycle.

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. 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 Immco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K032850

510(k) Number K032850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2003
Decision Date March 18, 2004
Days to Decision 188 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
84d slower than avg
Panel avg: 104d · This submission: 188d
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 K032850.
TECHLAB ASCA-CHEK
K051927 · Techlab, Inc. · Apr 2006
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