(129 days)
Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use to verify the performance and correct operation of the NIPRO TRUEresult Glucose Test Systems. Glucose Meter-Check Control Solution for NIPRO TRUEresult is intended for use by healthcare professionals and people with diabetes mellitus at home.
Glucose Meter-Check Control Solution for NIPRO TRUEresult 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 Glucose Meter-Check Control Solution is formulated for optimal performance on NIPRO TRUEresult glucose meters. The product is provided in 2 levels, 1 representing hypoglycemia (low blood glucose) and 2, representing typical fasting blood glucose levels in non-diabetic persons.
The provided text is a 510(k) summary for a medical device called "Glucose Meter-Check Control Solution for NIPRO TRUEresult." This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed acceptance criteria, specific study designs, or performance results in the format requested.
Therefore, I cannot populate the requested tables and sections regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. These details are typically found in more comprehensive study reports or clinical trial data, which are not present in this 510(k) summary.
The document does include the following limited information relevant to non-clinical tests:
Summary of Non-Clinical Tests (b) (1):
- Tests Conducted to Verify Specific Performance Requirements:
- Closed bottle stability (Shelf-life)
- Stability after opening (Use-life)
- Transport Stability
- Test response
Summary of Clinical Tests (b) (2):
- N/A (No clinical tests submitted with the premarket notification)
Conclusions (b) (3):
- "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence."
In conclusion, the document's purpose is to demonstrate substantial equivalence, and it does not provide the specific data points needed to fill out the detailed tables and sections you've requested regarding acceptance criteria and performance evaluation studies.
§ 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.