(49 days)
Interlab Immunofixation Electrophoresis Test is for the qualitative in vitro diagnostic separation and identification of abnormal immunoglobulins (IgG, IgM, IgA) and kappa and lambda light chains in human serum and concentrated urine using cellulose acetate supported on Mylar® for the Microtech 672 PC and IFX 600 instruments. This test is useful as an aid in identifying suspected monoclonal gammopathies.
Not Found
I am sorry, but based on the provided text, I cannot extract any information regarding acceptance criteria or a study that proves the device meets those criteria.
The document is an FDA 510(k) clearance letter for the "InterLab Immunofixation Electrophoresis Test System." It primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines the regulatory requirements for marketing the device.
Here's why I cannot fulfill your request:
- No Acceptance Criteria or Study Details: The letter does not contain a table of acceptance criteria, reported device performance metrics, sample sizes, data provenance, information about ground truth establishment, expert qualifications, adjudication methods, or details on comparative effectiveness studies (MRMC) or standalone performance studies.
- Focus on Substantial Equivalence: The FDA 510(k) process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on new studies proving specific acceptance criteria beyond what has been established for the predicate. While performance data would have been submitted to the FDA as part of the 510(k) application (K033187), those details are not included in this official clearance letter.
- Limited Scope of the Document: The document is primarily an administrative letter from the FDA, confirming clearance for marketing. It is not a scientific report or a summary of the performance study results.
To get the information you are looking for, you would need to access the full 510(k) submission document (K033187) or any associated performance study reports that InterLab Scientific Instruments SRL would have submitted to the FDA.
§ 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).