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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.

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.

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The Hypoguard 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 Hypoguard ADVANCE™ Blood Glucose Meter is intended for use with Hypoguard ADVANCE™ Blood Glucose Test Strips 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 Hypoguard ADVANCE™ Blood Glucose Test Strips are intended for use with Hypoguard ADVANCE™ Blood Glucose Meter 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.

Hypoguard ADVANCE™ Control Solution is intended for use with the Hypoguard ADVANCE™ Meter and Hypoguard ADVANCE™ Test Strips as a quality control check to verify the accuracy of blood glucose test results.

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The provided text is a U.S. FDA 510(k) clearance letter for the Hypoguard ADVANCE™ Blood Glucose Monitoring System. This document does not contain the detailed study information required to answer your prompt thoroughly.

Specifically, the letter states that the device is "substantially equivalent" to legally marketed predicate devices, which implies that its performance is comparable to existing glucose monitoring systems. However, it does not provide the acceptance criteria, the results of specific studies, sample sizes, expert qualifications, or ground truth methods related to the device's performance.

The letter confirms the "Indications For Use" for the Hypoguard ADVANCE™ system, meter, test strips, and control solution, which is that it's for quantitative measurement of glucose in fresh capillary whole blood for in vitro diagnostic use, both at home and in clinical settings, as an aid to monitor diabetes control.

To answer your specific questions, information about performance criteria and study details would typically be found in the 510(k) submission summary or in a separate study report, which is not part of this clearance letter.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method: Not present.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study, including effect size: Not present. Glucose meters are generally standalone, so an MRMC study with human readers would be exceptionally rare for this type of device.
6. Standalone (algorithm only) performance study: While the device is a standalone system, the details of its standalone performance study (e.g., accuracy metrics vs. a reference method) are not provided here.
7. Type of ground truth used: Not present, but for blood glucose meters, the ground truth is typically a laboratory reference method (e.g., YSI analyzer).
8. Sample size for the training set: Not applicable/not present. For a device like a blood glucose meter, the "training set" in an AI/algorithm sense is less relevant than the design, calibration, and validation against a reference method.
9. How the ground truth for the training set was established: Not applicable/not present.

In summary, the provided document is an FDA clearance letter and does not contain the detailed study results needed to answer your questions.

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