Cleared Traditional

K013283 - RELISA PR3-ANCA TEST SYSTEM FOR ANTIBOD...

K013283 is the FDA 510(k) clearance for RELISA PR3-ANCA TEST SYSTEM FOR ANTIBOD... by Immuno Concepts, Inc.. It is a Class 2 Immunology device (product code MOB) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K013283 · Immuno Concepts, Inc. · Immunology device
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Nov 2001
Decision
43d
Days
Class 2
Risk

K013283 is an FDA 510(k) clearance for the RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Immuno Concepts, Inc. (Dallas, US). The FDA issued a Cleared decision on November 14, 2001 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Immuno Concepts, Inc. devices

Submission Details

510(k) Number K013283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2001
Decision Date November 14, 2001
Days to Decision 43 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 104d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 35
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