(57 days)
This assay is intended for the in-vitro measurement of specific IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other clinical findings.
Not Found
The provided text is an FDA 510(k) clearance letter for the BINDAZYME Anti-dsDNA EIA device. This document confirms the device's substantial equivalence to a predicate device and its clearance for marketing. However, this type of regulatory document does not contain the detailed study information, acceptance criteria, or performance data that you have requested.
Specifically, the letter states:
- "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
- The "Indications For Use" describes the device's intended purpose (in-vitro measurement of specific IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other clinical findings).
To answer your questions about acceptance criteria, study design, sample sizes, ground truth establishment, or human reader performance, one would need access to the actual 510(k) submission document or the underlying scientific studies conducted by The Binding Site. This information is typically not included in the public-facing FDA clearance letter.
Therefore, I cannot provide the requested information based on the text provided.
§ 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).