(34 days)
The AVL OPTI Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, glucose, urea (BUN), total hemoglobin content and oxygen saturation in samples of whole blood, serum, plasma or dialysate in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.
The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in, 10 lbs], instrument using optical fluorescence for the measurement of pH, PCO2, sodium, potassium, ionized calcium, choride. glucose and urea (BUN) of whole blood, plasma, serum or dialysate as appropriate. In addition, it uses scattering for the measurement of total hemoglobin and oxygen saturation. A disposable, single-use cassette containing six optical fluorescence sensors is packaged in a sealed foil pouch which bears a bar-coded label with calibration and identification information. The OPTI can perform up to 8 tests on a single sample, determined by the type of disposable cassette used.
The provided text describes the AVL OPTI Critical Care Analyzer, focusing on its substantial equivalence to other marketed devices and its technological characteristics. However, it does not explicitly state specific acceptance criteria (e.g., performance thresholds like "accuracy must be within X%") in a table format, nor does it provide a detailed study that proves the device meets such criteria with quantitative results in the way you've requested.
Instead, the document focuses on:
- Demonstrating substantial equivalence: By comparing the AVL OPTI to existing devices and stating 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.