(164 days)
The iHealth Align Mini Gluco-Monitoring system(BG1) is intended to be used for:
- Quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh
- single person measurement only and should not be shared
- Self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control
The iHealth system should not be used for the diagnosis of or screening for diabetes, or for neonatal use.
Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly.
iHealth Blood Glucose Test Strips(AGS-1000I) are intended for use with the iHealth Align Mini Glucose meter (BG1) to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG1 meter.
The iHealth BG1 Align Mini Gluco-Monitoring System (BGMS) consists of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
The new device iHealth BG1 is based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device.
The appearance of iHealth BG1 is different from the predicate device. Both the iHealth BG1 and the predicate device BG3 need to connect to iOS device to display the rest results, however, iHealth BG1 connect to iOS device through the earphone kack, while BG3 connect to iOS device through the 30-pin dock interface.
Here's a breakdown of the acceptance criteria and study information for the iHealth BG1 Align Mini Gluco-Monitoring System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary states that the device conforms to ISO 15197: "In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus."
Given that the document is a 510(k) summary, it does not explicitly detail the entire set of ISO 15197 acceptance criteria in a table format. However, it indicates compliance with the standard. For a Class II device like a blood glucose monitoring system, the key performance criteria from ISO 15197 (at the time this 510(k) was likely submitted) generally revolve around accuracy percentages relative to a reference method.
Based on the information provided, here's a representation of the acceptance criteria and implied performance:
| Acceptance Criteria (Based on ISO 15197) | Reported Device Performance (Implied by compliance) |
|---|---|
| Accuracy (System Accuracy Evaluation): | |
| - For glucose concentrations |
§ 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.