(20 days)
The Hypoquard Advance Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The Hypoquard Advance Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Hypoguard Advance Blood Glucose Test Strips.
This 510(k) submission (K031388) describes a modification to the Hypoguard Advance Blood Glucose Monitoring System. The acceptance criteria and supporting studies are presented as relating to this modification, rather than the initial predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Acceptance criteria were met" for all described tests, but does not explicitly list the quantitative acceptance criteria. Therefore, the table below will reflect the reported outcome.
| Acceptance Criteria Category | Reported Device Performance | Specifics (if available) |
|---|---|---|
| Precision | Acceptance criteria were met. | Within run, between run, and total CV% were calculated identically to the original 510(k) and met acceptance criteria. |
| Dynamic Range | Validated. | Acceptance criteria were met. |
| Minimum Sample Volume | Validated. | Acceptance criteria were met. |
| Accuracy/Method Correlation | Acceptance criteria were met. | Compared against the original Hypoguard Advance System and the YSI 2300 analyzer. Clarke Error Grid Analysis acceptance criteria were met. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not specify the exact sample size for the clinical accuracy/method correlation testing or the precision studies.
- Data Provenance: The document does not explicitly state the country of origin.
- Retrospective or Prospective: Not specified. However, the nature of the "accuracy/method correlation testing" against a predicate and a reference method suggests a prospective study for data collection on the modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. This device measures glucose quantitatively using a reference analyzer (YSI 2300), not through expert interpretation of images or clinical assessments.
4. Adjudication Method for the Test Set:
Not applicable, as ground truth is established by a reference analyzer (YSI 2300), not expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a blood glucose monitoring system, and its performance is evaluated against a reference method, not through human reader interpretation or comparison with human readers' diagnostic accuracy.
6. Standalone Performance Study:
Yes, a standalone performance study was conducted. The accuracy/method correlation testing directly evaluated the algorithm/device's performance by comparing its glucose measurements against a reference standard (YSI 2300 analyzer) and the original Hypoguard Advance system.
7. Type of Ground Truth Used:
The ground truth for the clinical accuracy/method correlation study was established using the YSI 2300 analyzer, which is a widely accepted laboratory reference method for glucose measurement.
8. Sample Size for the Training Set:
This information is not provided. Given that this submission is for a modification to an existing device, it's possible that earlier versions of the device were trained on specific datasets, but this document does not detail training data for the modified system.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided.
§ 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.