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AESKULISA ß2 Glyco-A is a solid phase enzyme immunoassay employing native ß2 glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against ß2 glycoprotein I in human serum. The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.

AESKULISA ß2 Glyco-GM is a solid phase enzyme immunoassay employing native ß2 glycoprotein I highly purified from human plasma for the separate semiquantitative and qualitative detection of IgG and/or IgM antibodies against β2 glycoprotein I in human serum. The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.

AESKULISA ß2 Glyco-Check is a solid phase enzyme immunoassay employing native ß2 glycoprotein 1 highly purified from human plasma for the combined semiquantitative and qualitative detection of IgA, IgG and IgM antibodies against ß2 glycoprotein I in human serum. The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.

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I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them in the format you requested. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device. It defines the intended use of the devices (AESKULISA® ß2-Glyco-A, AESKULISA® ß2-Glyco-GM, AESKULISA® ß2-Glyco-Check) for detecting antibodies related to antiphospholipid syndrome.

However, the letter does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample size for test sets or their data provenance.
3. Information on the number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Results of Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
6. Results of standalone algorithm performance studies.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. The sample size for the training set.
9. How ground truth for the training set was established.

This document serves as a regulatory clearance notice, not a detailed study report or clinical trial summary. To get the information you are looking for, you would typically need to consult the full 510(k) submission, the device's labeling, or peer-reviewed publications related to the device.

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AESKULISA tTg A is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of Ig A antibodies against tissue transglutaminase (tTG) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

AESKULISA tTg G is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of Ig G antibodies against tissue transglutaminase (tTG) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

AESKULISA tTg A is a solid phase enzyme immunoassay.
AESKULISA tTg G is a solid phase enzyme immunoassay.

This FDA Premarket Notification (510(k)) letter does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance as it focuses on the substantial equivalence determination for regulatory purposes.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for a specific study.
• Information on expert involvement, adjudication methods, or multi-reader multi-case studies.
• Results of standalone algorithm performance.

The provided document is a regulatory approval letter stating that the AESKULISA tTg A and G assays are substantially equivalent to legally marketed predicate devices, and outlines their intended use as aids in the diagnosis of celiac disease. It does not delve into the specifics of the performance studies that would have been submitted as part of the 510(k) application.

To get the information you are looking for, you would typically need to refer to the actual 510(k) submission document itself (which is usually a much larger technical file) or scientific publications related to the device's validation. This approval letter is merely the FDA's formal response to that submission.

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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.

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AESKULISA Cardiolipin-AGM is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the semiquantitative and qualitative detection of IgA, IgG and /or IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2-glycoprotein I which are only expressed when ß2glycoprotein I interacts with cardiolipin.

The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings.

AESKULISA Cardiolipin-A is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the semiquantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2-glycoprotein | which are only expressed when ß2-glycoprotein | interacts with cardiolipin.

The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings.

AESKULISA Cardiolipin-GM is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the semiquantitative and qualitative detection of IgG and /or IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2-glycoprotein I which are only expressed when ß2-glycoprotein I interacts with cardiolipin.

The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings.

AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the combined semiquantitative and qualitative detection of IgA, IgG and IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2-glycoprotein I which are only expressed when ß2glycoprotein I interacts with cardiolipin.

The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjuction with other serological tests and clinical findings.

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I am sorry, but based on the provided document, there is no information about acceptance criteria, a study proving device performance, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.

The document contains:

• A letter from the FDA to Aesku. Inc regarding their 510(k) premarket notification for AESKULISA® Cardiolipin.
• Indications for Use statements for several AESKULISA® Cardiolipin products (AGM, A, GM, Check).

These sections describe the device, its intended use (detection of IgA, IgG, and/or IgM antibodies against cardiolipin to aid in the diagnosis of SLE, primary and secondary APS), and the FDA's determination of substantial equivalence to previously marketed devices. However, they do not include any technical study details or performance metrics.

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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.

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