Cleared Traditional

ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO

K140225 · Phadia US, Inc. · Immunology
Oct 2014
Decision
271d
Days
Class 2
Risk

About This 510(k) Submission

K140225 is an FDA 510(k) clearance for the ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Phadia US, Inc. (Freiburg Im Breisgau, DE). The FDA issued a Cleared decision on October 27, 2014, 271 days after receiving the submission on January 29, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K140225 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2014
Decision Date October 27, 2014
Days to Decision 271 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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
EUROIMMUN IFA Granulocyte Mosaic? EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic? EUROPattern
K172582 · Euroimmun Us, Inc. · May 2018
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
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
K112545 · Inova Diagnostics, Inc. · Jul 2012