Cleared Traditional

K243776 - Anti-Neutrophil Cytoplasmic Antibodies ...

Also marketed or referenced as:
Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)

K243776 is an FDA 510(k) clearance for Anti-Neutrophil Cytoplasmic Antibodies ..., manufactured by Zeus Scientific. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K243776 · Zeus Scientific · Immunology device
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May 2025
Decision
149d
Days
Class 2
Risk

K243776 is an FDA 510(k) clearance for the Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed). Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Zeus Scientific (Branchburg, US). The FDA issued a Cleared decision on May 7, 2025 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 Zeus Scientific devices

FDA 510(k) Submission Details - K243776

510(k) Number K243776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2024
Decision Date May 07, 2025
Days to Decision 149 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
45d slower than avg
Panel avg: 104d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOB Device Classification - Class 2, Special Controls

Product Code MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)

All 41
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