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anti-neutrophil cytoplasmic antibodies ethanol-fixed anti-neutrophil cytoplasmic antibodies formalin-fixed
Zeus Scientific
Summary: The device detects anti-neutrophil cytoplasmic antibodies (ANCA) using ethanol and formalin-fixed samples. Primarily used in diagnosing autoimmune vasculitides. Key evidence highlights its diagnostic importance in differentiating vasculitis types.
FDA Clearance Information
Pathway
510K
Number
K243776 ↗
Decision Date
May 7, 2025
Product Code
MOB
Device Class
Class 2
Evidence
419 studies
The device was cleared by the FDA through the 510k pathway on May 7, 2025. Manufactured by Zeus Scientific, it is classified as a Class 2 device under product code MOB.
What It Is
This device is used to detect anti-neutrophil cytoplasmic antibodies (ANCA) in patient samples. It employs both ethanol-fixed and formalin-fixed methods to identify antibodies associated with autoimmune vasculitides, aiding in the diagnosis and differentiation of conditions like granulomatosis with polyangiitis.
Clinical Applications
Commonly used in clinical settings to diagnose and monitor autoimmune vasculitides such as granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis, and microscopic polyangiitis. It provides critical information for distinguishing between these conditions.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and retrospective analyses, conducted between 2019 and 2025. These studies focus on the diagnostic utility and technological advancements in ANCA detection.
Reported Outcomes
Published studies report the device's efficacy in accurately detecting ANCA, which is crucial for diagnosing vasculitides. The use of both ethanol and formalin fixation methods enhances diagnostic precision, particularly in distinguishing between different types of vasculitis.
Safety Profile
Reported complications include potential false positives or negatives due to sample handling or fixation methods. However, no significant adverse events directly related to the device's use have been documented in the available literature.
Evidence Limitations
Current evidence is limited by the variability in study designs and the lack of large-scale, multicenter trials. Further research is needed to standardize testing protocols and confirm findings across diverse populations.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for anti-neutrophil cytoplasmic antibodies?
The device is indicated for diagnosing autoimmune vasculitides, including granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis, and microscopic polyangiitis.
What outcomes have been reported in clinical studies?
Studies report effective ANCA detection, aiding in the differentiation of vasculitis types, with improved diagnostic accuracy using both ethanol and formalin fixation methods.
What complications have been reported?
Reported complications include potential false results due to sample handling, but no significant adverse events related to the device itself have been noted.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.