(14 days)
AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG artibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells and spectic 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 theumatic 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 detection of IgG artibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells and spectic antigens.
I am sorry, but the provided text does not contain the detailed information necessary to complete all sections of your request regarding the acceptance criteria and the study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for a device called "AESKULISA ANA-HEp2," and while it states the device has been found substantially equivalent to a predicate device, it does not include the specific study details you are asking for.
Here's a breakdown of what I can and cannot provide based on the given text:
Information I CAN extract:
- Device Name: AESKULISA ANA-Hep2
- Indication for Use: A solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against HEp2 cells in human serum. It collectively detects total ANAs against 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). It's a tool in the diagnosis of certain systemic rheumatic diseases and should be used with other serological tests and clinical findings.
- Regulatory Information: Class II device, Product Code LKJ.
Information NOT present in the provided text:
- A table of acceptance criteria and the reported device performance: This document does not detail specific acceptance criteria or the performance metrics (e.g., sensitivity, specificity, accuracy) from the study.
- Sample sizes used for the test set and data provenance: The document does not mention the sample size of any test set or the origin of the data.
- Number of experts used to establish the ground truth for the test set and their qualifications: There is no mention of experts or ground truth establishment.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable as this is not an AI-assisted device based on the description.
- Standalone (algorithm only) performance: Not applicable as this is an immunoassay, not an algorithm.
- Type of ground truth used: Not specified.
- Sample size for the training set: There is no mention of a training set as this is an immunoassay, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
Therefore, I cannot fulfill your request for the specific study details as they are not contained within the provided FDA 510(k) clearance letter. This type of information would typically be found in the 510(k) submission summary or the actual study report, neither of which is present here.
§ 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).