(131 days)
mis kit is intended for separation and/or quantitations of serum proteins and immunoglobulins using agarose gel electrophoresis. mese tests can be useful in diagnosing various disease states which typically exhibit abnormal patterns. Examples of such diseases are inflamatory response, rheumatic fever, liver disease, protein-loss disorders, plasma cell dyscrasias, genetic deficiencies and gammopathies responsible for multiple myeloma, collagen disorders and other chronic infections.
SPIFETM Electrophoresis System
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 those criteria, as requested. The document is an FDA 510(k) clearance letter for the SPIFE™ Electrophoresis System, which indicates that the device has been found substantially equivalent to a predicate device.
The letter does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets, nor data provenance.
- Information about experts, ground truth establishment, or adjudication methods.
- Details on multi-reader multi-case studies or standalone algorithm performance.
Therefore, I cannot fulfill your request based on the provided input.
§ 862.1630 Protein (fractionation) test system.
(a)
Identification. A protein (fractionation) test system is a device intended to measure protein fractions in blood, urine, cerebrospinal fluid, and other body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants of proteins produced in diseases with tissue destruction.(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 § 862.9.