Immunoassay Control Set Access® IL-6 Positive Level / Negative Level 4 X 2.5 mL

Features

• The Access IL-6 Immunoassay is only for use under the Food and Drug Administration’s Emergency Use: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests
• This test has been authorized only to assist in identifying severe inflammatory response, when used as an aid in determining the risk of intubation with mechanical ventilation in confirmed COVID-19 patients
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner
• The Access IL-6 assay is an in vitro diagnostic test for the quantitative measurement of IL-6 (Interleukin 6) in human serum and plasma (heparin)
• Normal IL-6 results do not preclude development of a severe inflammatory response, and IL-6 should not be used as the sole basis for patient management decision
• Results must be combined with clinical observations, patient history, other laboratory parameters, and epidemiological information
• For use with Access Family of Immunoassay Systems: Access 2, UniCel DxC 600i, UniCel DxI 600, UniCel DxI 800, UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, UniCel DxC 660i

More Information

• Beckman ACCESS IL-6 Assay FDA EUA Letter
• Beckman ACCESS IL-6 Healthcare Providers Fact Sheet
• Beckman ACCESS IL-6 Patients Fact Sheet
• SDS