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This document outlines the Bi-Rad Laboratories submission for a Special 510(k) to modify the BioPlex 2200 ANA Screen with Medical Decision Support Software (MDSS), detailing its intended use, classification,
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How to fill out bioplex 2200 ana screen
How to fill out BioPlex 2200 ANA Screen with MDSS 510(k) Summary
01
Gather necessary materials: BioPlex 2200 ANA Screen kit, samples, and necessary reagents.
02
Prepare the samples according to the kit instructions, ensuring they are properly labeled.
03
An aliquot of the patient serum is drawn for analysis.
04
Set up the BioPlex 2200 instrument following the manufacturer's operational guidelines.
05
Calibrate the instrument if necessary, using the provided calibrators.
06
Load the prepared samples onto the instrument and select the appropriate test settings.
07
Run the BioPlex 2200 ANA Screen assay as per the manufacturer’s instructions.
08
Review the results after the analysis is complete and follow guidelines for interpretation.
09
Document and report the findings according to laboratory protocols.
Who needs BioPlex 2200 ANA Screen with MDSS 510(k) Summary?
01
Clinicians and healthcare providers looking to diagnose autoimmune diseases.
02
Laboratory professionals performing serological tests for autoimmune conditions.
03
Patients presenting symptoms suggestive of autoimmune disorders such as lupus or rheumatoid arthritis.
04
Researchers studying autoimmune mechanisms or conducting clinical trials related to autoimmune diseases.
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People Also Ask about
What test is performed on the BioPlex?
BioPlex is an automated, multiplex flow immunoassay that provides separate results for detection of -1 p24 Ag, -1 Ab (groups M and O), and -2 Ab [7]. Previous reports indicate that the overall sensitivity and specificity of the BioPlex assay are similar to other Ag/Ab assays [8–10].
What is an ANA multiplex test?
ANA Multiplex, with Reflex to dsDNA - This multiplex immunoassay detects common antinuclear antibodies (ANAs) that are associated with autoimmune diseases. With a reflex to double-stranded DNA (dsDNA), this test may aid in the evaluation of systemic lupus erythematosus (SLE).
How to interpret ANA screen results?
A negative interpretation means your child's blood had no detectable levels of ANAs. An autoimmune disorder is less likely. A positive interpretation means your child's blood had detectable levels of ANAs. An autoimmune disorder is possible, but more tests are necessary to confirm.
What is BioPlex CTD screen?
BioPlex 2200 ANA Screen with MDSS Panel Aids clinicians in precisely diagnosing connective tissue diseases including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome (SS), scleroderma (Systemic Sclerosis), dermatomyositis, polymyositis and CREST syndrome.
What is a CTD test?
AVISE CTD combines AVISE Lupus, a 10-marker diagnostic test designed to help rule-in or rule-out lupus, with an expanded connective tissue disease panel to aid in the differential diagnosis of other connective tissue diseases.
What is a Bioplex CTD screen?
This multiplex test panel detects and differentiates clinically relevant antinuclear antibodies used to aid in diagnosing connective tissue diseases (CTDs).
What is the ANA Bioplex blood test?
Anti-nuclear antibody (ANA) testing can be used for the assessment of systemic autoimmune disease/ connective tissue disease. Indicated in Systemic autoimmune disease/connective tissue disease.
What is a CTD screen test?
The CTD screen is a bead based fluoroenzymeimmunoassay containing the following recombinant antigens; dsDNA, Ro52, Ro60, SSB/La, Sm, U1RNP (RNP-70, A, C), Jo-1, Scl-70, CENP-B, Mi-2, RNA Pol III, PM-Scl, PCNA, Ribosomal P, and Fibrillarin. Clinical Indications. Suspected connective tissue disease.
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What is BioPlex 2200 ANA Screen with MDSS 510(k) Summary?
The BioPlex 2200 ANA Screen with MDSS 510(k) Summary is a document that outlines the characteristics and performance data of the BioPlex 2200 ANA Screening test, which is used to detect antinuclear antibodies in human serum.
Who is required to file BioPlex 2200 ANA Screen with MDSS 510(k) Summary?
Manufacturers of the BioPlex 2200 ANA Screen or any entity wishing to market this diagnostic test in the United States are required to file the 510(k) summary with the FDA.
How to fill out BioPlex 2200 ANA Screen with MDSS 510(k) Summary?
To fill out the BioPlex 2200 ANA Screen with MDSS 510(k) Summary, manufacturers must provide detailed information about the device, its intended use, performance data, labeling, and any relevant testing that supports its safety and efficacy.
What is the purpose of BioPlex 2200 ANA Screen with MDSS 510(k) Summary?
The purpose of the BioPlex 2200 ANA Screen with MDSS 510(k) Summary is to demonstrate to the FDA that the device is safe, effective, and substantially equivalent to other legally marketed devices for the same intended use.
What information must be reported on BioPlex 2200 ANA Screen with MDSS 510(k) Summary?
The information that must be reported includes device description, labeling, intended use, performance characteristics, clinical data, testing methods, and any adverse effects associated with the device.
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