(522 days)
The microdot 9 Home Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use only), by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended for "single patient-home use" only and should not be shared. It should be used only for testing fresh capillary whole blood samples from a fingerstick or palm for glucose (sugar). Alternate site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus.
The system consists of the microdot® Home Blood Glucose meter, microdot® Home Test Strips and microdot® Control solutions.
microdot® Home Test Strips
The microdot® Home Test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick or palm.
The microdot® Home Blood Glucose Monitoring System consists of the microdot® Home Blood Glucose Meter, microdote Home Test Strips, microdot Control Solutions and a commercially available (510(k) cleared) lancing device and lancets. A clear cap is provided with the lancing device for alternate site testing on the palm. microdote Home Blood Glucose Monitoring System is for a single patient use only. The meter and lancing device must not be shared with anyone.
microdot® Home is an auto code system. The meter turns on upon insertion of the strip, a blood sample from the finger or palm is applied to the test strip and after 10 seconds, the plasma glucose result is displayed on the screen in mg/dL only.
microdot Home Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and specifications as the predicate system, microdot® Xtra Blood Glucose Monitoring System. It relies on quantitative electrochemical biosensor technology to measure current generated on disposable test strips.
The strip remains unchanged since the last submission approval, microdot® Xtra Blood Glucose Monitoring System (K083273). The Test Strip manufacturing and performance characteristics are unchanged. The test strips are designed to quantitatively measure glucose in fresh capillary blood from the fingertip by persons with diabetes.
The microdot® Home Blood Glucose Monitoring System device received 510(k) clearance (K102383) in 2012. The submission focused on adding palm testing as an alternate site for an existing product.
Here's an analysis of the acceptance criteria and the study that supports it:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for glucose monitoring systems for self-testing are generally defined by ISO 15197. The document explicitly references ISO15197:2003: in vitro diagnostic test systems - requirements for blood-glucose monitoring systems for self testing in managing diabetes mellitus (Section 8: User Performance). While the exact acceptance criteria thresholds from ISO15197:2003 are not explicitly listed in the 510(k) summary, the performance data is presented in a way that suggests alignment with such standards, using percentage agreement within specific glucose ranges and mg/dL deviations.
The performance is reported against a reference method, likely YSI (Yellow Springs Instrument), which is a common laboratory reference for glucose measurement.
| Sites tested | Performance for glucose levels
§ 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.