(579 days)
This assay is designed for the in vitro measurement of human C4 in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal C4 metabolism.
Not Found
I am sorry, but based on the provided document, the information you are requesting about acceptance criteria and a study proving a device meets these criteria is not present. The document is an FDA 510(k) clearance letter for a device called "C4 Minineph Antiserum." It confirms the device's substantial equivalence to a predicate device and its regulatory classification, but it does not detail:
- Specific acceptance criteria for performance metrics.
- A study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance, expert qualifications, or adjudication methods.
- Results of MRMC comparative effectiveness or standalone studies.
- How ground truth was established for training or test sets.
The document primarily states the device's "Indications for Use" which is for "in vitro measurement of human C4 in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal C4 metabolism."
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).