Cleared Traditional

K962360 - IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES

K962360 is an FDA 510(k) clearance for IFA KIT FOR THE DETECTION OF C-ANCA ANT..., manufactured by Scimedx Corp.. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K962360 · Scimedx Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
103d
Days
Class 2
Risk

K962360 is an FDA 510(k) clearance for the IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Scimedx Corp. (Denvill, US). The FDA issued a Cleared decision on September 30, 1996 after a review of 103 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 Scimedx Corp. devices

FDA 510(k) Submission Details - K962360

510(k) Number K962360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1996
Decision Date September 30, 1996
Days to Decision 103 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
2d faster than avg
Panel avg: 105d · This submission: 103d
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 59
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K962360.
MYELOPEROXIDASE ELISA TEST SYSTEM
K964446 · Zeus Scientific, Inc. · Apr 1997
PROTEINASE-3 IGG ELISA TEST SYSTEM
K964448 · Zeus Scientific, Inc. · Apr 1997
ANCA SCREEN ELISA TEST SYSTEM
K964449 · Zeus Scientific, Inc. · Apr 1997
PR-3 ELISA TEST SYSTEM
K961764 · Immunoprobe, Inc. · Aug 1996
MPO ELISA TEST SYSTEM
K961765 · Immunoprobe, Inc. · Aug 1996
NOVA LITE ANCA
K961340 · Inova Diagnostics, Inc. · Jul 1996