REAADS Monoclonal Free Protein S Antigen 051-001

GUDID 00855360006014

INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Free Protein S Antigen in citrated human plasma. For In Vitro Diagnostic Use. SUMMARY AND EXPLANATION OF THE PROTEIN S TEST Protein S is a vitamin K-dependent protein synthesized in the liver, vascular endothelium, and megakaryocytes, which plays an important physiologic role in the Protein C Anticoagulant System. This anticoagulant system is one of the major regulators of hemostasis by inhibiting clot formation and by promoting fibrinolysis. Protein S functions as a cofactor for activated Protein C on the vascular membrane to facilitate the degradation of clotting factors Va and VIIIa, down-regulating clot formation. In normal plasma approximately 40% of Protein S circulates as a free molecule, while 60% is complexed with C4b, a plasma protein of the classical complement pathway. Only Free Protein S is functionally active and able to bind to activated Protein C, while the complexed form of Protein S is not. Protein S deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. The prevalence of Protein S deficiency has been estimated to be less than 1 case per 300 in the general population. Two-thirds of patients with a congenital deficiency of Protein S (levels less than 50% of normal) may present with venous thrombosis in young adulthood. In young patients (<35 years) with a history of thrombosis, the prevalence may be as high as 15 to 18%. Acquired Protein S deficiency may be seen during pregnancy, oral contraceptive or oral anticoagulant therapy, liver disease, diabetes mellitus, postoperative complications, septicemia, and various inflammatory syndromes. A decreased Protein S activity in plasma may be the result of low concentrations or abnormal function of the Protein S molecule. Refer to Product Package Insert.

CORGENIX MEDICAL CORPORATION

Protein S IVD, kit, chromogenic

• Primary Device ID: 00855360006014
• NIH Device Record Key: b4dbc5be-c3ed-4118-aa13-e52753bee401
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REAADS Monoclonal Free Protein S Antigen
• Version Model Number: 051-001
• Catalog Number: 051-001
• 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	00855360006014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983914

FDA Product Code

• GGP: Test, Qualitative And Quantitative Factor Deficiency

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: 2016-07-14

Devices Manufactured by CORGENIX MEDICAL CORPORATION

• 00855360006007 - REAADS Protein S Antigen Test kit: 2018-07-06 INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Total and Free Protein S Antigen
• 00855360006014 - REAADS Monoclonal Free Protein S Antigen: 2018-07-06INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Free Protein S Antigen in citrated human plasma. For In Vitro Diagnostic Use. SUMMARY AND EXPLANATION OF THE PROTEIN S TEST Protein S is a vitamin K-dependent protein synthesized in the liver, vascular endothelium, and megakaryocytes, which plays an important physiologic role in the Protein C Anticoagulant System. This anticoagulant system is one of the major regulators of hemostasis by inhibiting clot formation and by promoting fibrinolysis. Protein S functions as a cofactor for activated Protein C on the vascular membrane to facilitate the degradation of clotting factors Va and VIIIa, down-regulating clot formation. In normal plasma approximately 40% of Protein S circulates as a free molecule, while 60% is complexed with C4b, a plasma protein of the classical complement pathway. Only Free Protein S is functionally active and able to bind to activated Protein C, while the complexed form of Protein S is not. Protein S deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. The prevalence of Protein S deficiency has been estimated to be less than 1 case per 300 in the general population. Two-thirds of patients with a congenital deficiency of Protein S (levels less than 50% of normal) may present with venous thrombosis in young adulthood. In young patients (
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