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An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum and plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

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The retrieved document is a 510(k) premarket notification letter from the FDA regarding the Olympus Unsaturated Iron Binding Capacity device. This type of document does not typically contain the detailed technical study information requested, such as specific acceptance criteria, performance data, sample sizes for test and training sets, ground truth establishment, or details about expert involvement and adjudication.

The letter primarily focuses on:

• Confirming the review of the premarket notification.
• Determining substantial equivalence to a predicate device.
• Stating the device's regulation number, regulation name, and regulatory class.
• Specifying the "Indications for Use" for the device, which is to measure iron-binding capacity in serum and plasma for the diagnosis and treatment of anemia.

Therefore, I cannot extract the requested information from the provided text.

To answer your questions, one would need access to the actual 510(k) submission document or supporting studies that detail the device's performance validation.

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