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immuglo anti-neutrophil cytoplasmic antibody anca test sytem
Immco Diagnostics
Summary: The Immuglo ANCA Test System is a diagnostic tool used to detect anti-neutrophil cytoplasmic antibodies, aiding in the diagnosis of autoimmune vasculitis. It is primarily used by rheumatologists and clinical laboratories.
FDA Clearance Information
Pathway
510K
Number
K982898 ↗
Decision Date
November 30, 1998
Product Code
MOB
Device Class
Class 2
Evidence
419 studies
The Immuglo ANCA Test System was cleared through the FDA 510k pathway on November 30, 1998. Manufactured by Immco Diagnostics, it is classified as a Class 2 device under product code MOB.
What It Is
The Immuglo ANCA Test System is a diagnostic assay designed to detect anti-neutrophil cytoplasmic antibodies (ANCA) in patient samples. These antibodies are often present in autoimmune conditions such as granulomatosis with polyangiitis and microscopic polyangiitis. The test utilizes immunofluorescence techniques to visualize the presence of these antibodies, providing clinicians with critical information for diagnosis and management.
Clinical Applications
This test is commonly used in rheumatology and nephrology settings to diagnose and monitor autoimmune vasculitis. It is particularly useful in evaluating patients presenting with symptoms like unexplained renal impairment, respiratory issues, or systemic inflammation. The test is typically performed in specialized clinical laboratories equipped to handle immunofluorescence assays.
Indications for Use
The FDA-cleared indications for the Immuglo ANCA Test System include aiding in the diagnosis of autoimmune vasculitis conditions, such as granulomatosis with polyangiitis. It is indicated for patients who present with symptoms suggestive of these conditions.
Practical Considerations
Clinicians should ensure samples are collected and handled according to laboratory standards to maintain test accuracy. The test requires specific laboratory equipment and trained personnel to interpret the immunofluorescence patterns accurately. Compatibility with other diagnostic assays should be considered when integrating into a diagnostic workflow.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
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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
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PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
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PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
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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
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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
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PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
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PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
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PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
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PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
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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
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PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
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PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
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PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
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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 is the Immuglo ANCA Test System used for?
It is used to detect anti-neutrophil cytoplasmic antibodies, aiding in the diagnosis of autoimmune vasculitis.
What specialties typically use this device?
Rheumatology and nephrology specialties commonly use this test in clinical laboratory settings.
What are the FDA-cleared indications?
The test is indicated for diagnosing autoimmune vasculitis conditions like granulomatosis with polyangiitis.
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.