Cleared Traditional

EUROIMMUN IFA Granulocyte Mosaic? EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic? EUROPattern

K172582 · Euroimmun Us, Inc. · Immunology
May 2018
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K172582 is an FDA 510(k) clearance for the EUROIMMUN IFA Granulocyte Mosaic? EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic? EUROPattern, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Euroimmun Us, Inc. (Mountain Lakes, US). The FDA issued a Cleared decision on May 24, 2018, 269 days after receiving the submission on August 28, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K172582 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2017
Decision Date May 24, 2018
Days to Decision 269 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

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

Similar Devices — MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)

All 73
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
K243776 · Zeus Scientific · May 2025
AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
K172461 · Aesku.Diagnostics GmbH & Co. KG · Mar 2018
EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
K173792 · Phadia AB · Mar 2018
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
K161258 · Inova Diagnostics, Inc. · Feb 2017
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
K140225 · Phadia US, Inc. · Oct 2014
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
K112545 · Inova Diagnostics, Inc. · Jul 2012