(422 days)
UriTest- Protein in Urine is a non-quantitative screening test to identify protein in urine. Protein in urine can be associated with renal, kidney or bladder disease.
Not Found
I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the "Uri-Test Protein in Urine" device, stating that it is substantially equivalent to a predicate device.
The letter mentions:
- Device Name: Uri-Test - Protein in Urine
- Indication for Use: A non-quantitative screening test to identify protein in urine. Protein in urine can be associated with renal, kidney, or bladder disease.
- Regulatory Class: I
- Product Code: JIR
However, it does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample size, data provenance, or ground truth for any study.
- Information about expert involvement, adjudication, or MRMC studies.
- Data on standalone algorithm performance or training set details.
This document is a notification of regulatory clearance, not a study report or a summary of performance data.
§ 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.