Cleared Traditional

K010289 - SCIMEDX PHASE II MPO IGG ANTIBODY EIA

K010289 is an FDA 510(k) clearance for SCIMEDX PHASE II MPO IGG ANTIBODY EIA, 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 35-day FDA review.

K010289 · Scimedx Corp. · Immunology device
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Mar 2001
Decision
35d
Days
Class 2
Risk

K010289 is an FDA 510(k) clearance for the SCIMEDX PHASE II MPO IGG ANTIBODY EIA. 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 March 7, 2001 after a review of 35 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 Scimedx Corp. devices

FDA 510(k) Submission Details - K010289

510(k) Number K010289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2001
Decision Date March 07, 2001
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 105d · This submission: 35d
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 60
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K010289.
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
K040111 · Zeus Scientific, Inc. · Apr 2004
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
K013283 · Immuno Concepts, Inc. · Nov 2001
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
K013285 · Immuno Concepts, Inc. · Nov 2001
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
K002215 · Cogent Diagnotics , Ltd. · Sep 2000
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
K001127 · The Binding Site, Ltd. · Aug 2000
AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
K990796 · Cogent Diagnotics , Ltd. · Apr 1999