Cleared Traditional

K964446 - MYELOPEROXIDASE ELISA TEST SYSTEM

K964446 is an FDA 510(k) clearance for MYELOPEROXIDASE ELISA TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K964446 · Zeus Scientific, Inc. · Immunology device
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Apr 1997
Decision
155d
Days
Class 2
Risk

K964446 is an FDA 510(k) clearance for the MYELOPEROXIDASE ELISA TEST SYSTEM. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on April 10, 1997 after a review of 155 days - an extended review cycle.

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, Inc. devices

FDA 510(k) Submission Details - K964446

510(k) Number K964446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1996
Decision Date April 10, 1997
Days to Decision 155 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
51d slower than avg
Panel avg: 104d · This submission: 155d
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
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K964446.
PR 3 ANTIBODY KIT
K973823 · Hemagen Diagnostics, Inc. · Nov 1997
VIRGO PANCO KIT
K973824 · Hemagen Diagnostics, Inc. · Nov 1997
ANCA COMBI DIAGNOSTIC TEST KIT
K965133 · The Binding Site, Ltd. · May 1997
PROTEINASE-3 IGG ELISA TEST SYSTEM
K964448 · Zeus Scientific, Inc. · Apr 1997
ANCA SCREEN ELISA TEST SYSTEM
K964449 · Zeus Scientific, Inc. · Apr 1997
NOVA LITE ANCA
K961340 · Inova Diagnostics, Inc. · Jul 1996