(17 days)
Nova Glucose Low/High Level Control Solutions are assayed quality control materials, which are used to verify the performance of BD Logic Blood Glucose Monitor, BD Latitude Diabetes Management System, BD/MiniMed Blood Glucose Monitor, and MiniMed Paradigm Link Blood Glucose Monitor. This control is an OTC product intended for use in the home setting.
The Nova Glucose Low/High Level Control Solutions are for in vitro diagnostic use ONLY.
Nova Glucose Low/High Level Control Solutions
The provided documents do not contain information about acceptance criteria or a study proving that a device meets such criteria. The documents are a 510(k) premarket notification letter for "Nova Glucose Low/High Level Control Solutions" and its "Indications for Use" statement.
Specifically, the letter is a determination by the FDA that the Nova Glucose Low/High Level Control Solutions are substantially equivalent to a legally marketed predicate device. This type of notification does not typically include detailed study results or acceptance criteria in the public release.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.