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NycoCard U-Albumin is intended to measure by immunochemical techniques the albumin (a plasma protein) in urine. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

NycoCard U-Albumin Control consists of two control materials based on human urine and is intended to be used to confirm the efficacy of the NycoCard U-Albumin reagents and correct performance of the test.

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The provided text is an FDA 510(k) clearance letter for the NycoCard U-Albumin and NycoCard U-Albumin Control devices. It does not contain the detailed study information required to answer questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications for a study proving device adherence to acceptance criteria.

The document primarily focuses on:

• Device Name: NycoCard U-Albumin and NycoCard U-Albumin Control
• Regulation Number and Name: 21 CFR § 866.5040, Albumin immunological test system
• Regulatory Class: Class II
• Product Code: DCF, JJX
• Indications For Use: To measure albumin in urine by immunochemical techniques, aiding in the diagnosis of kidney and intestinal diseases. The control material confirms the efficacy of reagents and correct test performance.
• FDA Clearance: States that the device is substantially equivalent to legally marketed predicate devices.

Therefore, based only on the provided text, I cannot complete a table of acceptance criteria and reported device performance or answer most of the requested study-specific questions.

The document states FDA's determination of "substantial equivalence" based on "indications for use stated in the enclosure." A full 510(k) submission would contain data demonstrating this equivalence, but that data is not included in the provided snippets.

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