(69 days)
LifeScan OneTouch Ultra Control Solution is intended for use to verify the performance of the LifeScan OneTouch Ultra Family and the OneTouch Ping™ Meter Remote blood glucose monitoring test systems at a glucose level printed on the test strip vial. The LifeScan OneTouch Ultra Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.
LifeScan OneTouch Select Control Solution is intended for use to verify the performance of the LifeScan OneTouch Select blood glucose monitoring test system at a glucose level printed on the test strip vial. The LifeScan OneTouch Select Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.
LifeScan OneTouch Vita Control Solution is intended for use to verify the performance of the LifeScan OneTouch Vita blood glucose monitoring test system at a glucose level printed on the test strip vial. The LifeScan OneTouch Vita Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.
For In Vitro Diagnostic Use
The control solution is a buffered aqueous solution with glucose containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation. The primary differences in the composition of the OneTouch Select, Ultra and Vita branded Control Solutions to that of the current, OneTouch Ultra Control are the type and relative content of buffer system, type and relative content of the viscosity adjusting agent, type and relative content of the preservative system, a lower concentration of dye, and a relative reduction in the content of water. The OneTouch Ultra control is currently in use with all LifeScan blood glucose test systems under the OneTouch Ultra, OneTouch Select and OneTouch Vita brands. The new control solution is reformulated for optimized performance across these various brands of test strips, and will be distributed under the same brands as the current Ultra control.
This material consists of viscosity-adjusted, aqueous glucose control solution prepared with a single concentration of D-glucose with recovery on the test systems in the range typically considered normal, fasting glucose for a non-diabetic person. This solution has been optimized to simulate the response of whole blood on the LifeScan OneTouch Ultra, Select and Vita branded blood glucose test systems. The solution contains no hazardous, human or animal derived components.
The provided text describes a 510(k) summary for LifeScan OneTouch Select, Ultra, and Vita Control Solutions. This document outlines the control solutions' characteristics and intended use, comparing them to a predicate device to establish substantial equivalence. However, it does not contain detailed information about acceptance criteria or specific studies proving device performance against those criteria in the format requested.
The document states that "Tests were conducted to verify specific performance requirements" and lists
- a) Closed bottle stability (Shelf-life)
- b) Stability after opening (Use-life)
- c) Transport Stability
- d) Test response
But it does not provide the acceptance criteria for these tests, nor the results of these tests, therefore it is not possible to complete the table or the rest of the requested information.
The document explicitly states "Summary of clinical tests submitted with the premarket notification for the device. (b) (2) N/A", indicating that no clinical tests were submitted. Therefore, it is impossible to extract information about sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance. The ground truth for training also cannot be determined from this document.
In summary, the provided text is a 510(k) summary focused on demonstrating substantial equivalence of control solutions, not on providing detailed performance study results against specific acceptance criteria.
§ 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.