(87 days)
The contents of the Peliclass ™ subclass nephelometric Array® kit will allow quantitative determination of all four IgG subclasses in at least 25 samples with the Beckman Array ® Protein System. The determination of IgG subclasses is to be used in conjunction with other clinical findings to aid in the assessment of the humoral immune status.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device (Peliclass Human IGG Subclass Nephelometric Array Kit). It does not contain specific information about acceptance criteria or a study that proves the device meets those criteria in the way described in your request.
The letter confirms that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. This substantial equivalence is based on the information provided by the manufacturer in their 510(k) submission, which typically includes performance data. However, the letter itself does not detail that data.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not on a detailed scientific study report.
§ 866.5530 Immunoglobulin G (Fc fragment specific) immunological test system.
(a)
Identification. An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.