(281 days)
The iHealth Align Gluco-Monitoring System consists of the iHealth Align Glucose meter (BG1), iHealth Blood Glucose Test Strips (AGS-1000), and the iHealth Gluco-Smart App mobile application as the display component of the iHealth Align Gluco-Monitoring System. The iHealth Align Gluco-Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, upper arm, calf, or thigh. The iHealth Align Gluco-Monitoring System is intended to be used by a single person and should not be shared.
The iHealth Align Gluco-Monitoring System is intended for 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 Align Gluco-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 iHealth Align Gluco-Monitoring System(BG1) consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
They are 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.
In order to use the iHealth Align Gluco-Monitoring system(BG1) , a compatible Android or iOS mobile device with the necessary mobile application installed is required.
The provided text describes the iHealth Align Gluco-Monitoring System (BG1) and its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested.
The document is a 510(k) summary for a glucose monitoring system, focusing on demonstrating substantial equivalence to a previously cleared device. It highlights the technological characteristics and intended use. While it mentions performance characteristics like measurement range and test time, it doesn't present a table of acceptance criteria with corresponding device performance for a specific study.
Therefore, I can extract information related to the device's characteristics and the submission's intent, but I cannot fulfill all sections of your request directly from the provided text as the specific clinical study data (including sample sizes, ground truth establishment, expert qualifications, and adjudication methods for acceptance criteria) is not present.
Here's a breakdown of what can be extracted and what cannot:
Information that CANNOT be extracted from the provided text:
- A table of acceptance criteria and the reported device performance because the document focuses on demonstrating substantial equivalence through technological comparison rather than presenting the results of a primary clinical validation study against predefined acceptance metrics.
- Sample sizes used for the test set and data provenance for a specific clinical validation study.
- Number of experts used to establish the ground truth and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
- Whether a standalone (algorithm only) performance study was done. (This device is a physical glucose meter, not an AI algorithm.)
- The sample size for the training set. (This is a medical device, not an AI algorithm that typically has a "training set" in the machine learning sense.)
- How the ground truth for the training set was established.
Information that CAN be extracted or inferred:
1. Acceptance Criteria and Reported Device Performance:
While a formal "acceptance criteria" table is not provided, the document lists key performance characteristics assumed to meet regulatory expectations. The predicate device's performance, which the new device is compared against, indirectly sets the "acceptance criteria" for substantial equivalence.
| Characteristic | Reported Device Performance and Substantial Equivalence |
|---|---|
| Detection Method | Amperometry (Same as predicate) |
| Enzyme | Glucose Oxidase (Same as predicate) |
| Type of Meter | Biosensor (Electrode) (Same as predicate) |
| Sample Source | Capillary whole blood from AST and finger (Same as predicate) |
| Sample Application | Blood sample placed directly to test strip (Same as predicate) |
| Hematocrit Range | 20-60% (Same as predicate) |
| Operating Temperature Range | 10℃~35℃ (50°-95°F) (Same as predicate) |
| Display | Connect to iOS device and Android device to display measurement results (Predicate connected only to iOS; this is a difference noted, but considered not to raise new safety/effectiveness questions) |
| Result Presentation | mg/dL or mmol/L (Same as predicate) |
| Memory Capabilities | 10000 times with time and date displaying (Same as predicate) |
| Test Start | Automatic (Same as predicate) |
| Test Time | 5 seconds (Same as predicate) |
| Power Source | DC3.0V (CR1620) (Same as predicate) |
| Measurement Range | 20mg/dL-600mg/dL (1.1mmol/L~33.3mmol/L) (Same as predicate) |
| Qualified Test Strip | AGS-1000I Test Strip (Same as predicate) |
| Sample Volume | Minimum 0.7 microliter (Same as predicate) |
| Connect Method | Connect to iOS device and Android device through Earphone jack (Predicate connected only to iOS; this is a difference noted, but considered not to raise new safety/effectiveness questions) |
7. Type of Ground Truth Used:
The device measures chemical properties (glucose levels). The "ground truth" for such devices is typically established through a laboratory reference method (e.g., using a YSI glucose analyzer) on the same blood sample. While not explicitly stated, this is the standard for glucose meter validation.
The 510(k) summary explicitly states that the submission aims to demonstrate that "these small differences [referring to the expanded compatibility with Android devices] do not raise any new questions of safety and effectiveness," thus proving its substantial equivalence to the predicate device. This implies that the device performance for glucose measurement itself is considered equivalent to the predicate, which would have undergone its own rigorous testing against a reference standard.
§ 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.