(79 days)
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.
Not Found
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.
§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.