(127 days)
AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa U1 snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm. Sm and SS-A 60 kDa. The assay is an aid in the differential J diagnosis of systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.
AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. The wells are coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is an aid in the differential diagnosis of systemic rheumatic diseases and should be used in coniunction with other serological tests and clinical findings.
AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human 70 kDa protein of the U1-snRNP complex for the semi-quantitative and qualitative detection of antibodies against the 70 kDa U1-RNP in human serum. The assay is an aid in the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
AESKULISA snRNP-C is a solid phase enzyme immunoassay for the qualitative and semi-quantitative detection of antibodies against the snRNP complex in human serum. The assay employs native human U1-snRNP complex purified from the cell-line HeLa. The U1-snRNP complex comprises of the Smith antigen (Sm) and RNPs, the 70kDa U1-specific protein plus protein A and C. The assay is an aid for the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
AESKULISA Sm is a solid phase enzyme immunoassay with purified native Smith antigen (Sm) from human eukaryotic cells (HeLa) for the qualitative and semiquantitative detection of antibodies against Sm in human serum. Anti-Sm antibodies recognize specific conformational epitopes only accessible on native human Sm. The assay is an aid in the differential diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
AESKULISA SS-A is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of antibodies against Ro/ SS-A in human serum. The assay employs human Ro/SS-A antigen composed of purified native 60kDa and recombinant human 52 kDa Ro/SS-A protein. Anti-SS-A antibodies preferentially react with the native 60kDa molecule where as most antibodies to the 52 kDa protein prefer the denatured molecule. The assay is an aid in the diagnosis of Sjögren's syndrome (SS) and systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant La-antigen/ SS-B for the qualitative and semi-quantitative detection of antibodies against La-antigen / SS-B in human serum. The assay is an aid in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 kDa fragment of DNA topoisomerase I for the qualitative and semi-quantitative detection of antibodies against Scl-70 (70 kDa scleroderma antigen) in human serum. The assay is an aid in the differential diagnosis of systemic sclerosis and should be used in conjunction with other serological tests and clinical findings.
AESKULISA CENP-B is a solid phase enzyme immunoassay employing purified recombinant human 80 kDa centromere protein B (Cenp-B) for the qualitative and semiquantitative detection of IgG antibodies against Cenp-B in human serum. The assay serves as an aid in the diagnosis of systemic sclerosis and CREST syndrome and should be used in conjunction with other serological tests and clinical findings.
AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histidyl-tRNA-synthetase (HRS) for the semi-quantitative and qualitative detection of antibodies against Jo-1 in human serum. The assay is an aid in the diagnosis of polymyositis and dermatomyositis and should be used in conjunction with other serological tests and clinical findings.
Solid phase enzyme immunoassay kits for the detection of IgG antibodies against various cellular and nuclear antigens in human serum. The specific antigens coated on the wells vary depending on the specific kit (e.g., AESKULISA ANA 8Pro, AESKULISA ENA 6Pro, etc.).
I am sorry, but without the actual study itself, I cannot provide an answer that includes the acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, details about MRMC studies, standalone performance, ground truth types, or training set information. The provided text only contains the FDA 510(k) clearance letters and "Indications For Use" for several AESKULISA test kits, which describe what the devices are intended to diagnose but do not include performance study results or acceptance criteria.
§ 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).