ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.— 510(k) K153551

Substantially Equivalent

Axis-Shield Diagnostics Limited

FDA 510(k) clearance K153551 for ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials., Substantially Equivalent on 2016-08-04. Applicant: Axis-Shield Diagnostics Limited. Device class: 2.

Clearance details

Applicant: Axis-Shield Diagnostics Limited
Product code: Code NHX
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 2015-12-11
Decision date: 2016-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHX

K143754 — QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP32015-09-21
K121576 — IMMULITE 2000 ANTI-CCP IGG ASSAY2013-04-04
K112810 — MULTI-ANALYTE DETECTION SYSTEMS2011-10-26
K110296 — AXIS-SHIELD ANTI-CCP2011-08-18
K093908 — CCPOINT2010-12-01

More clearances from Axis-Shield Diagnostics Limited

Recalls naming K153551

K-number listed on FDA's recall record

Z-2754-2019 — Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments. [Note: the Atellica IM anti-CCP IgG (aCCP) assay was introduced for sale through the Replacement Reagent Policy.]Class II·Terminated·Siemens Healthcare Diagnostics, Inc·20190814

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153551.

Data sourced from openFDA. This site is unofficial and independent of the FDA.