(32 days)
Sysmex® UF-1000i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-1000i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell and Mucus.
The Sysmex® UF-1000i, an automated urine particle analyzer, is a dedicated system for the analysis of microscopic formed elements in urine specimens. The instrument consists for three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples; (2) Auto Sampler Unit supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system. The UF-1000i is equipped with a Sampler that provides continuous automated sampling for up to 50 tubes.
The instrument utilizes Sysmex flow cytometry using a red semiconductor laser for analyzing organized elements of urine. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using its own reagents, the UF-1000i automatically classifies organized elements of urine and carries out all processes automatically from aspiration of the sample to outputting the results.
Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.
The provided text is a 510(k) summary for the Sysmex® UF-1000i with Urinalysis WAM. It details the device, its intended use, and substantial equivalence to a predicate device, but it does not contain detailed information about acceptance criteria or specific studies proving device performance against such criteria for the Urinalysis WAM software.
The key assertion made in the document is about the substantial equivalence of the modified device (UF-1000i with Urinalysis WAM) to the predicate device (UF-1000i without Urinalysis WAM). The document states: "Design validation studies were completed and sample integrity study was performed. and there is no difference between the UF-1000i and the UF-1000i with Urinalysis WAM software." and "The UF-1000i with Urinalysis WAM software demonstrates substantial equivalence to the UF-1000i without the Urinalysis WAM software."
Therefore, the provided text does not offer the specific granular details (acceptance criteria tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) that would typically be found in a detailed study report demonstrating performance against acceptance criteria for a new device or a significant modification.
Based on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and a study proving the device meets them because this specific detail is not present. The document focuses solely on asserting substantial equivalence through a modification that is stated to have "no difference" in how the core analytical function performs.
§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).