(133 days)
Microalbuminurea has been shown to predict the development of clinically significant nephropathy in diabetic patients. This Urinary Microalbumin Assay Kit is an in vitro immunoturbidimetric test for the quantitative determination of the native, immunoreactive albumin present in human urine.
EnZIP IMMUNOTURBIDIMETRIC URINARY MICROALBUMIN KIT
The provided text does not contain information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. The document is an FDA 510(k) clearance letter for the "Immunoturbidimetric Urinary Microalbumin Assay Kit," dating back to 1997. It primarily focuses on the regulatory approval, indicating that the device is substantially equivalent to previously marketed devices.
The only relevant information related to the device is its intended use, as stated in the "Indications for Use" section:
- Indications for Use: "Microalbuminurea has been shown to predict the development of clinically significant nephropathy in diabetic patients. This Urinary Microalbumin Assay Kit is an in vitro immunoturbidimetric test for the quantitative determination of the native, immunoreactive albumin present in human urine."
Therefore, I cannot fulfill the request for information on acceptance criteria, study details, and data provenance based on the provided text.
§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.(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 § 862.9.