(122 days)
The Diagnostic Chemicals Limited's Salicylate method is an in vitro diagnostic device intended to measure salicylate levels in human serum or plasma (Lithium heparin). intended to modellio balleyfato to the diagnosis of salicylate toxicity and overdose.
Not Found
The provided text is a 510(k) clearance letter for a Salicylate test system. This type of document does not typically contain the detailed information requested regarding acceptance criteria, study design, or ground truth establishment relevant to AI/ML device performance.
The letter confirms that the device, Salicylate, Cat.Nos.511-20 and 511-40, is substantially equivalent to legally marketed predicate devices for measuring salicylate levels in human serum or plasma to aid in the diagnosis of salicylate toxicity and overdose.
Therefore, I cannot provide the requested information based on the input text. The information is pertaining to a traditional in vitro diagnostic device, not an AI/ML device which would involve specific performance metrics and validation studies against a ground truth as outlined in your request.
§ 862.3830 Salicylate test system.
(a)
Identification. A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.(b)
Classification. Class II.