(80 days)
Ultra + Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit.
Ultra + Aqueous Glucose Control Low and Ultra + Aqueous Glucose Control High are ready to use solutions, which contain a specific amount of glucose.
This document is a 510(k) clearance letter from the FDA for a medical device called "Ultra Aqueous Glucose Controls." It is a regulatory approval document and does not contain the information requested in your prompt regarding acceptance criteria and study details.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It mentions the product code (JJX) and regulatory class (I), and states the intended use: "Ultra + Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit."
To answer your specific questions, a different type of document, such as a summary of safety and effectiveness, a clinical study report, or even the original 510(k) submission, would be required. This letter only provides the outcome of the FDA's review, not the detailed data or studies performed.
§ 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.