(72 days)
AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative Adelection of IgG antibodies against HEp-2 cells in human serum. Each well is coated with lysed HEp2 cells and specific antigens. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A(Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT).
The assay is a tool in the diagnosis of certain systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.
AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative Adelection of IgG antibodies against HEp-2 cells in human serum. Each well is coated with lysed HEp2 cells and specific antigens.
This document is a 510(k) clearance letter from the FDA for a medical device called AESKULISA ANA Hep-2. It does not contain the detailed study information required to fill out the table and answer the questions about acceptance criteria and device performance.
The provided text only includes:
- The device name: AESKULISA ANA Hep-2
- The regulation number and name: 21 CFR 866.5100, Antinuclear antibody immunological test systems
- The product code: LKJ
- The indications for use: combined qualitative detection of IgG antibodies against HEp-2 cells in human serum, collectively detecting total ANAs against various antigens, and serving as a tool in the diagnosis of certain systemic rheumatic diseases to be used with other tests and clinical findings.
To answer your questions, I would need a detailed study report, clinical trial results, or data from the 510(k) submission itself which would provide specific performance metrics, study designs, and ground truth methodologies. This information is not present in the provided FDA clearance letter.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).