(24 days)
ABL555 is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH, pCO2, pO2 Na+, K+, Hct, and the option of one of the following parameters: ClT or Ca2 or glucose or lactate.
ABL555 is an automated blood gas, electrolyte and metabolite analyzer that is 40 cm x 55 cm x 40 cm (WHD) and weighs 37.5 kg. It measures on whole blood in approximately 54 seconds.
The provided text is a 510(k) summary for the ABL555 Blood Gas, Electrolyte, and Metabolite Measuring System. It describes the device and its intended use but does not contain information about acceptance criteria, device performance, studies, sample sizes, ground truth establishment, or expert involvement for performance evaluation.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on the substantial equivalence of the ABL555 to previously marketed devices (ABL555, EML105, i-STAT Model 100, and Corning 348) and the regulatory approval process.
The relevant sections of the input text explicitly state that the ABL555 is technologically similar to the current version ABL555 and is substantially equivalent in features and characteristics to the current ABL555 marketed by Radiometer America Inc. (K973367). The major difference is the addition of the lactate and hematocrit. This implies that the device is being approved based on its similarity to an already approved device, rather than through new performance studies detailing acceptance criteria and outcomes.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.