(50 days)
The AVL OMNI™ Analyzer is intended to be used for the measurement of pH , pCO2, pCO2 , sodium, potassium, ionized calcium, chloride, hematocrit and total hemoglobin and the hemoglobin derivatives: OzHb, COHb, MetHb, HHb,SulfHb and metabolites; glucose and lactate in samples of whole blood, serum, plasma, aqueous solutions as appropriate, in a clinical laboratory setting by personnel minimally qualified to perform and to report these results.
The AVL OMNI™ is a modular Critical Care Analyzer intended to be used for the measurement of pH, PCO2, PO2, ctHb, HHb, O2Hb, COHb, MetHb, SulfHb, Nat, K+, CI, ionized Ca*, Hematocrit, glucose and lactate in whole blood, serum, plasma, dialysate and QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting.
The AVL OMNI™ Analyzer is a fully-automatic, microprocessor-controlled system that can perform up to 16 tests per sample.
The provided text describes the AVL OMNI™ Combi Analyzer and its intended use, but it does not contain a specific section detailing the acceptance criteria and a study proving the device meets those criteria in a structured table or comprehensive study report. The document describes non-clinical tests for precision and linearity for Glucose and Lactate as additions to previous submissions, and clinical tests to demonstrate correlation with legally marketed predicate devices.
However, based on the provided text, I can infer details regarding the "Precision" and "Linearity" tests for the added Glucose and Lactate analytes, which are key performance indicators for this type of device.
Here's an attempt to construct the requested information, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for precision or linearity. Instead, it describes how precision and linearity were determined and then concludes that there was "no significant difference in mean values (P
§ 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.