Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody) 11854

GUDID 00855360006236

INTENDED USE An enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with β2-glycoprotein I (β2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). For In Vitro Diagnostic Use Only. SUMMARY AND EXPLANATION OF THE ASSAY The antiphospholipid syndrome (APS) is one of the most common causes of acquired hypercoagulability (thrombophilia) It is frequently diagnosed in the context of a systemic autoimmune disorder such as SLE (secondary APS), however, it may also occur in the absence of an obvious underlying disease (primary APS). Oxidative stress and oxLDL formation are common in patients with SLE and APS suggesting an important relationship between lipid peroxidation and clotting activation (hypercoagulability). The presence of circulating IgG anti-oxLDL-β2GPI antibodies seem to be etiologically important. PRINCIPLE OF THE TEST This test is an indirect ELISA detecting IgG anti-oxLDL-β2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL- β2GPI complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added. Following another wash, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgG anti-oxLDL-β2GPI antibody. Results are obtained by reading the OD of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-β2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean O.D.’s. Controls and patient results are determined from the calibration curve. Refer to product package insert.

CORGENIX MEDICAL CORPORATION

Oxidized low density lipoprotein-B2-glycoprotein I (OxLDL-B2GPI) complex antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00855360006236
• NIH Device Record Key: 2611afe2-115f-40d5-8020-415fffb22dc8
• Commercial Distribution Discontinuation: 2017-02-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody)
• Version Model Number: 11854
• Catalog Number: 11854
• Company DUNS: 619834542
• Company Name: CORGENIX MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-729-5661
• Email: technicalsupport@corgenix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855360006236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072032

FDA Product Code

• MSV: System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-08

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