(63 days)
This reagent is for the quantitative enzymatic determination of glucose in serum or plasma. For in vitro diagnostic use only.
Raichem® Glucose UV Reagent
Regrettably, without further context from the 510(k) submission for the Raichem® Glucose UV Reagent (K012668), I am unable to describe the acceptance criteria and the study that proves the device meets them.
The provided text is an FDA clearance letter for the device, which confirms substantial equivalence to a predicate device but does not detail the specific performance studies, acceptance criteria, or their results.
To answer your request, I would need access to the actual 510(k) summary or the full submission, which would typically contain:
- A performance study section: This would outline the design of the study, the chosen acceptance criteria, and the results obtained for accuracy, precision, linearity, etc.
- Details on sample sizes and provenance.
- Information on ground truth establishment and experts used.
- Information on standalone performance.
Without this information, I cannot provide the requested table or descriptions. The provided document only confirms the regulatory clearance based on substantial equivalence.
§ 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.