(118 days)
The UniCel DxC 800 System Software Version 5.0 is a fully automated, computercontrolled clinical chemistry analyzer intended for the in vitro determination of a variety of cleared clinical laboratory assays, such as glucose.
GLUCm reagent is intended for the quantitative determination of glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
The UniCel® DxC 800 SYNCHRON® System equipped with Software Version 5.0 is member of the SYNCHRON family of clinical chemistry analyzers, manufactured and distributed by Beckman Coulter, Inc. The SYNCHRON instrument family includes the SYNCHRON CX Clinical Chemistry Systems (CX4/CE/Δ/PRO, CX5/CEIA/PRO. CX7/RTS/&/PRO, CX9ALX/PRO), and the SYNCHRON LX Clinical Chemistry Systems (LX20/PRO/LXi 725). The UniCel DxC Systems are distinquished from other SYNCHRON systems in that they utilize more advanced hardware and software to improve system robustness and serviceability, and offer enhancements and features for user convenience. The analyzers operate in conjunction with reagents, calibrators, and controls designed for use with SYNCHRON Systems.
The provided text does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. Instead, it describes a 510(k) premarket notification for a software update to a clinical chemistry analyzer. The document states that "Performance data from validation testing (provided in the 'Performance Characteristics' section of this submission) supports equivalency," but the details of this validation testing, including acceptance criteria and reported performance, are not included in the provided excerpt.
Therefore, I cannot populate the table or provide specific details for points 1-9 as the information is not present in the given text.
However, based on the information provided, I can infer the following:
- Device: UniCel® DxC 800 SYNCHRON® Clinical System Software Version 5.0
- Intended Use: A fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of cleared clinical laboratory assays, such as glucose. Specifically, the GLUCm reagent is for the quantitative determination of glucose concentration in human serum, plasma, urine, or cerebrospinal fluid (CSF).
- Goal of Submission: To demonstrate substantial equivalence to previous versions (UniCel® DxC 600/800 SYNCHRON® System Software Version(s) 1.0 and 1.4).
- Method of demonstration: Comparison of software and hardware to the predicate platforms and demonstration of performance characteristics of a representative chemistry menu (including module chemistry and cartridge chemistry sections).
Missing Information:
The crucial information about the acceptance criteria, the actual performance results of the validation testing, the study design, sample sizes, ground truth establishment, and expert involvement is not present in this excerpt of the 510(k) submission.
General Statement based on the text:
The submission asserts that "Performance data from validation testing... supports equivalency," implying that internal acceptance criteria were met to demonstrate that the new software version performs equivalently to the predicate devices for glucose measurement and other assays. However, the specific details of these criteria and the data itself are not part of this document.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.