REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit (96-Well) 026-001

GUDID 00855360006052

INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use. SUMMARY AND EXPLANATION OF THE IGA TEST Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgA labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, 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 IgA aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgA aCL concentration expressed in APL units. The O.D. values of the controls and patient samples are multiplied by the conversion factor to obtain IgA aCL values, expressed in APL units. Control and patient results are determined from the calibration curve. Refer to Package Insert.

CORGENIX MEDICAL CORPORATION

Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00855360006052
• NIH Device Record Key: d6457755-ee3f-4298-92e9-c210d5eae6c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit (96-Well)
• Version Model Number: 026-001
• Catalog Number: 026-001
• 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	00855360006052 [Primary]

FDA Product Code

• MID: System, Test, Anticardiolipin Immunological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-14

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