(194 days)
The Q.STEPS Biometer G/C Dual Monitoring System is intended for use with Q.STEPS Glucose and Cholesterol Test Strips with Q.STEPS Biometer G/C System by healthcare professionals and home users. Q.STEPS Biometer G/C System provides a quantitative measurement of Glucose and Cholesterol in whole blood from the fingertips. The Glucose measurements are used in helping the management of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors. Cholesterol measurements are used in the management of disorders involving excess cholesterol in the blood, lipid and lipoprotein metabolism disorders.
The Q. STEPS™ Biometer G/C Dual Monitoring System uses enzymatic electrochemical biosensor technology for a quick and easy measurement of the whole blood glucose and cholesterol levels. When finger stick blood is applied to the test spot of the biosensor (test strip), a reduction oxidation reaction of D-Glucose or Cholesterol occurs, which is catalyzed by Glucose Oxidase and Cholesterol Oxidase respectively, and therefore, the magnitude of the electron transfer at the electrode is proportional to the glucose or cholesterol concentration in the blood. The monitor will quantify the glucose and the cholesterol levels in the blood, and then display on the readout of the monitor.
The provided 510(k) summary for the Q.STEPS™ Biometer G/C Dual Monitoring System does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria. The summary focuses primarily on device description, classification, predicate devices, and intended use, rather than a detailed performance study report.
However, based on the available information regarding the device's function (measuring glucose and cholesterol), and common practices for such devices, we can infer some general acceptance criteria and discuss the provided information.
Here's an attempt to structure the answer based on the prompt and the limited information:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state specific acceptance criteria in terms of numerical accuracy targets (e.g., +/- 15% for glucose, specific bias, precision values). It also does not report detailed device performance data from a specific study.
For a glucose and cholesterol meter, typical acceptance criteria, often outlined in standards like ISO 15197 for blood glucose monitoring systems, would include:
| Metric (Inferred) | Acceptance Criteria (Inferred from industry standards) | Reported Device Performance (Not explicitly stated in this document) |
|---|---|---|
| Glucose Measurement | ||
| Accuracy (vs. Lab Ref.) | e.g., >95% of results within ±15 mg/dL or ±15% | Not reported |
| Repeatability (Precision) | e.g., CV |
§ 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.