(61 days)
For semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketone bodies, urobilinogen, bilirubin and blood in urine by reflectance photometry with the Urisys 2400 photometer.
The Urisys 2400 Urine Test Strips are used in conjunction with the Urisys 2400 photometer. The Urisys 2400 photometer is an automated urinalysis system, class I exempt device, regulation number 21CFR 862.2900. The Urisys 2400 photometer determines specific gravity, sample color, and sample clarity and reflectance measurements of test parameters on the Urisys 2400 Urine Test Strips.
The Urisys 2400 Urine Test Strips are intended for the semi-quantitative determination of various analytes in urine. The study presented compares its performance to the predicate device, the Roche Diagnostics Chemstrip 10 S-UA test strips (K934042).
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria for each analyte that must be met for the Urisys 2400 Urine Test Strip to demonstrate substantial equivalence. Instead, the performance evaluation relies on a comparison of results between the Urisys 2400 system and the predicate device (Chemstrip 10 S-UA) when measuring patient samples, and a comparison against a reference method (microscopic evaluation for leukocytes, color comparison for others) for some analytes. The goal is to show comparable performance.
| Analyte | Acceptance Criteria (Implied: Comparable to Predicate/Reference) | Reported Device Performance (vs. Predicate/Reference) |
|---|---|---|
| pH | Comparable semi-quantitative results to predicate. | Compared with predicate (Chemstrip 10 S-UA): 99.4% agreement on +/- 1 pH unit and 205 of 200 samples (p= |
§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.