(110 days)
ImmunoCAP Total IgE is an in vitro test system for the quantitative measurement of circulating total IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories. ImmunoCAP Total IgE is to be used with the instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000.
ImmunoCAP Total IgE Control LMH is used for monitoring ImmunoCAP Total IgE measurements performance in Phadia instruments.
ImmunoCAP Total IgE reagents and control are modular in concept and are available individually. For a complete listing of reagents needed to perform the ImmunoCAP Total IgE assay, please consult the ImmunoCAP Total IgE Directions for Use.
Phadia 100. Phadia 250. Phadia 2500 and Phadia 5000 instruments with associated software process all steps of the assay and calculate results automatically after the assay is completed.
Anti-IgE, covalently coupled to ImmunoCAP, reacts with the total IgE in the patient sample. After washing, enzyme labeled antibodies against IgE are added to form a complex. Following incubation, unbound enzyme-anti-IgE is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The fluorescence is directly proportional to the concentration of IgE in the sample. The higher the response, the more IgE is present in the sample. To evaluate the test results, the responses for the patient samples are transformed to concentrations with the use of a calibration curve.
This document is a 510(k) summary for the ImmunoCAP Total IgE System. The submission describes a change to the format of the Directions for Use, merging three existing documents into one, with minor editorial changes. The summary explicitly states that "The change does not affect the Intended Use / Indications for Use Statement and it does not affect the safety or effectiveness of the ImmunoCAP Total IgE system, as cleared under K964152."
Therefore, this 510(k) submission does not include any new studies or acceptance criteria to prove the device meets performance standards. It relies on the previously established substantial equivalence and performance data from the predicate device (K964152).
Given this, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the provided text, as no such information is presented in this specific submission.
If you have access to the original 510(k) (K964152) for the ImmunoCAP Total IgE, that document would contain the efficacy studies and acceptance criteria for the device itself.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).