(91 days)
The Healthpro™ Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.
The Healthpro™ Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The Healthpro™ Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The Healthpro™ Professional test strips are for use with the Healthpro™ Professional meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.
The Healthpro™ Professional Control Solutions are for use with the Healthpro™ Professional meter and Healthpro™ Professional test strips to check that the meter and test strips are working together properly and that the test is performing correctly.
Prescription Use (Part 21CFR 801Subpart D)
The Healthpro™ Professional Blood Glucose System consists of a meter, test strips and control solutions (Level 1, Level 2 and level 3). The blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
The provided text is a 510(k) summary for the Healthpro™ Professional Blood Glucose Monitoring System. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain specific acceptance criteria or the details of a study that proves the device meets such criteria.
The section "8. Performance Data" states: "Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the Healthpro™ Professional Blood Glucose Monitoring System. The device passed all of the tests based on pre-determined Pass/Fail criteria."
This statement confirms that performance data exists, and the device passed tests based on criteria, but it does not provide the actual acceptance criteria or the specific results of those tests. Therefore, I cannot generate the requested table and detailed study information based on the input text.
To answer your request, the provided document is missing the following crucial information:
- Specific Acceptance Criteria: What were the "pre-determined Pass/Fail criteria"? For a blood glucose meter, this would typically involve accuracy metrics like ISO 15197 standards (e.g., percentage of results within a certain range of a reference method).
- Reported Device Performance: The actual measured accuracy, precision, or other performance statistics obtained during the validation studies.
- Study Design Details: Sample size, data provenance, ground truth establishment methods, number/qualifications of experts, adjudication methods for any accuracy studies mentioned.
- Training Set Details: Sample size and ground truth establishment for any training data (though for a blood glucose meter, the "training" would be more about calibration and internal algorithms, not typically a machine learning training set in the AI sense).
Without these details, I cannot fulfill your request for a table of acceptance criteria and proven performance, nor can I elaborate on the study specifics.
§ 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.