(88 days)
The Express 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 health care professionals, as an aid to monitor the effectiveness of diabetes control.
Express Control Solution is intended for use with the Express as a quality control check to verify the accuracy of blood glucose test results. Use the Express Control Solution to verify that the Express System is functioning properly.
The Express Blood Glucose Monitoring System includes a disposable meter containing 100 biosensors (test strips) plus 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 healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.
Here's an analysis of the provided text regarding the Express Blood Glucose Monitoring System, formatted to address your specific points:
Since this is a blood glucose monitoring system, the "acceptance criteria" are typically related to the accuracy and precision of glucose measurements, often compared against a reference method (like a YSI analyzer) or a predicate device. The "device performance" refers to the results obtained from the non-clinical and clinical testing sections.
Acceptance Criteria and Reported Device Performance
| Criteria Type | Acceptance Criteria (Implied) | Reported Device Performance and Evidence |
|---|---|---|
| Precision | Within-run and between-run precision values should be substantially equivalent to the predicate device and meet FDA Guidance Document recommendations. | Within-run Precision: Twenty replicates at six glucose concentrations across the performance range for six spiked venous whole blood samples. Performed within four hours of blood collection. Between-run Precision: Twenty replicates per day at six glucose concentrations using six tests with six different blood donors. Result: "The within-run and between-run precision values were substantially equivalent to that of the predicate." |
| Hematocrit Effect | Acceptable accuracy within the tested hematocrit range. | Study Design: Evaluated at a range of hematocrit levels from 30% to 55%. YSI plasma-referenced data used for comparison. Result: "Results showed acceptable accuracy within this hematocrit range." |
| Altitude Effect | No significant effect on performance due to high elevation. | Study Design: Tested using two control solutions and capillary whole blood spiked to three different levels. Performed at 800-feet and 40,000-feet elevations. Result: "Evaluation of mean values and CVs indicated no significant effect of high elevation on performance. The Express Blood Glucose Monitoring System is qualified at altitudes up to 10,000 ft. above sea level." (It's important to note the device is qualified to 10,000 ft, even though testing went up to 40,000 ft, suggesting that the 40,000 ft test might have demonstrated the lack of effect up to the qualified altitude). |
| Dynamic Range / Linearity | Good performance across the specified dynamic range (20-600 mg/dL). | Study Design: Testing conducted using venous blood spiked with D-glucose to provide samples across the 20-600 mg/dL dynamic range. Used Express Strip Readers and one YSI glucose analyzer. Result: "The results demonstrated good performance across the 20-600 mg/dL range." |
| Accuracy / Method Correlation | Good correlation with the YSI plasma reference method, and substantially equivalent regression statistics to the predicate device. | Study Design: Compared Express Strip Reader against the predicate and the YSI 2300 analyzer (reference method). Included men and women, Type 1 and Type 2 diabetes, ages 18-80s, and a wide range of educational levels. Blood glucose values encompassed 30-90 mg/dL (low end) to over 250 mg/dL (high end). Result: "Linear regressions statistics showed good correlation between Express Strip Reader results and the YSI plasma reference method, whether testing was carried out by the clinician or the patient. Regression statistics were substantially equivalent to those obtained for the predicate device." |
Additional Information Addressing Your Request:
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Sample size used for the test set and the data provenance:
- Precision Study:
- Within-run: Twenty replicates.
- Between-run: Twenty replicates per day.
- Blood Donors: Six different blood donors (for between-run).
- Hematocrit Study: Not specified how many samples or donors were used for the hematocrit range evaluation, only the range of hematocrit (30-55%).
- Altitude Study: Not specified, only mentions "two control solutions and capillary whole blood spiked to three different levels."
- Dynamic Range/Linearity: Not specified how many samples/replicates were used, only that venous blood was spiked to cover the range.
- Accuracy/Method Correlation: Not explicitly stated, but implies a diverse group of "both men and women, both Type 1 and Type 2 diabetes, ages from eighteen to eighties, and a wide range of educational levels" was included.
- Data Provenance: Not explicitly stated, but typically clinical studies for 510(k) submissions in the US are conducted in the US. The reference to "YSI plasma-referenced data" suggests a well-established laboratory method for comparison. The studies appear to be prospective as they describe specific testing protocols.
- Precision Study:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is an in-vitro diagnostic device measuring a quantitative analyte (glucose). The "ground truth" is established by a highly accurate reference instrument (YSI 2300 analyzer) or by comparing against the predicate device. No human expert consensus for image interpretation is involved.
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Adjudication method for the test set:
- Not applicable. The "ground truth" (reference method) for glucose measurement doesn't involve subjective human adjudication. It's an objective measurement compared against another objective measurement.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an imaging AI device requiring human reader interpretation or assistance. The study evaluates the device's accuracy in measuring glucose, which is a standalone quantitative measurement. The "patient use" aspect of the accuracy study implies that both clinicians and patients used the device, suggesting a form of usability/performance evaluation for different user groups, but not an MRMC study in the typical AI sense.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this entire study is effectively a standalone performance evaluation of the device (Express Strip Reader) itself. While patients and clinicians used the device, their role was as the users performing the test, not as "human-in-the-loop" for an algorithm's decision-making process. The system provides a direct blood glucose measurement.
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The type of ground truth used:
- Reference Method: YSI 2300 analyzer (for accuracy/method correlation, hematocrit, and dynamic range).
- Predicate Device: Hypoguard Advance™ Blood Glucose Monitoring System (for substantial equivalence claims in precision and accuracy).
- Spiked Samples: Used in precision, altitude, and dynamic range studies where known concentrations of glucose were introduced into blood samples or control solutions.
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The sample size for the training set:
- This is a traditional medical device (blood glucose meter), not an AI/machine learning product. Therefore, there is no "training set" in the context of machine learning model development. The device relies on a pre-programmed electrochemical or optical methodology, not a learned algorithm.
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How the ground truth for the training set was established:
- Not applicable for the same reason as point 7.
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MAR 2 8 2003
510(k) Summary
| 1. SUBMITTED BY: | Bruce A. MacFarlane, Ph.D. 5182 West 76th Street Edina, MN 55439 USA |
|---|---|
| ------------------ | ------------------------------------------------------------------------- |
Summary prepared: 20th December 2002
| 2. NAME OF DEVICES: | |
|---|---|
| Trade Names: | Express Blood Glucose Monitoring System Express Strip Reader Express Test Strips Express High Control Solution Express Normal Control Solution |
| Common Names/Descriptions: | Blood glucose monitoring system |
| Classification Names: | - Glucose test system, product codes CGA, NBW, 21 CFR 862.1345 - Single (specified) analyte controls (assayed/unassayed), product code JJX, 21 CFR 862.1660 |
| Regulatory Status: | Class II |
| PREDICATE DEVICE: | Hypoguard Advance™ Blood Glucose Monitoring System |
- DEVICE DESCRIPTION:
The Express Blood Glucose Monitoring System includes a disposable meter containing 100 biosensors (test strips) plus 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 healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.
4. INTENDED USE:
The Express 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 health care professionals, as an aid to monitor the effectiveness of diabetes control.
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5. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The Express Blood Glucose Monitoring System has the same technological characteristics as the predicate device, except that it has self-contained test strips.
6. NON-CLINICAL TESTING
Precision Study: Testing was performed using venous whole blood spiked to provide samples at six glucose concentrations across the performance range of the system. The within-run precision tests consisted of twenty replicates inclusive of the six-spiked whole blood glucose reference levels recommended by FDA Guidance Document. The within-run tests were performed within four hours of blood collection. The between-run precision tests consisted of twenty replicates per day at the six glucose concentrations using six tests with six different blood dlonors. The within-run and between-run precision values were substantially equivalent to that of the predicate.
Hematocrit Study: The hematocrit effect was evaluated at a range of hematocrit levels from 30% to 55%. YSI plasma-referenced data was used for comparison. Results showed acceptable accuracy within this hematocrit range.
Altitude Study: Testing was conducted using two control solutions and capillary whole blood spiked to three different levels. The study was performed at 800-feet and 40.000-feet elevations. Evaluation of mean values and CVs indicated no significant effect of high elevation on performance. The Express Blood Glucose Monitoring System is qualified at altitudes up to 10,000 ft. above sea level.
Dynamic Range/Linearity: Testing was conducted using venous blood spiked with Dglucose to provide samples to test the 20-600 mg/dL dynamic range. Testing was conducted using Express Strip Readers, and one YSI glucose analyzer, The results demonstrated good performance across the 20-600 mg/dL range.
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- CLINICAL TESTING
Accuracy/method correlation testing was done comparing the Express Strip Reader against the predicate and the YSI 2300 analyzer (reference method). Testing included both men and women, both Type 1 and Type 2 diabetes, ages from eighteen to eighties, and a wide range of educational levels. Tested blood glucose values encompassed the 30-90 mg/dL range on the low end to values over 250 mg/dL at the high end. Linear regressions statistics showed good correlation between Express Strip Reader results and the YSI plasma reference method, whether testing was carried out by the clinician or the patient. Regression statistics were substantially equivalent to those obtained for the predicate device.
- CLINICAL TESTING
8. CONCLUSIONS FROM TESTING
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Testing demonstrated that the performance of the Express Blood Glucose Monitoring System was substantially equivalent to that of the predicate.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top half. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, with three human profiles incorporated into the design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 8 2003
Bruce A. MacFarlane, Ph.D. Vice President, Regulatory Affairs and Quality Systems Hypoguard USA, Inc. 5182 West 76th Street Edina, MN 55439
Re: K024347
Trade/Device Name: Express Blood Glucose Monitoring System Regulation Number: 21 CFR 862. 1345 Regulation Name: Glucose Test Systems Regulatory Class: Class II Product Code: CGA , NBW Dated: December 20, 2002 Received: December 30, 2002
Dear Dr. MacFarlane:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications For Use
Page 1 of 1
510(k) Number (if known):
Device Name:
Express Blood Glucose Monitoring System
Indications For Use:
Express Blood Glucose Monitoring System:
The Express 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 clinical settings by health care professionals, as an aid to monitor the effectiveness of diabetes control.
Express Control Solution:
Express Control Solution is intended for use with the Express as a quality control check to verify the accuracy of blood glucose test results. Use the Express Control Solution to verify that the Express System is functioning properly.
510(k) Number
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
§ 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.