(20 days)
For the quantitative determination of iron in serum. For IN VITRO diagnostic use.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Serum Iron-SL Assay." This type of document is a regulatory approval, not a scientific study report. It states that the device is "substantially equivalent" to previously marketed devices.
Therefore, the input does not contain the detailed information necessary to answer the questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies for a medical device. These details would typically be found in a clinical study report or a more comprehensive submission document, not in the FDA clearance letter itself.
The document only provides:
- Device Name: Serum Iron-SL Assay
- Indications For Use: For the quantitative determination of iron in serum. For IN VITRO diagnostic use.
- Regulatory Class: II
Without a study report, I cannot complete the requested tables and descriptions.
§ 862.1410 Iron (non-heme) test system.
(a)
Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal 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 § 862.9.