(27 days)
The GlucoLeader Enhance Self-Monitoring of Blood Glucose 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.
The GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System is comprised of two main parts a bio-active electrode (test strip) containing the enzyme glucose oxidase and the glucose meter. The blood sample is drawn into the Test Strip through capillary action. Glucose in the sample reacts with glucose oxidase and potassium ferricyanide in the strip, producing ferrocyanide. Potassium ferrocyanide is produced in proportion to the glucose concentration of the blood sample. Oxidation of the potassium ferrocyanide produces an electrical current which is then converted by the meter to display the glucose concentration.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly stated in terms of specific performance thresholds (e.g., a certain percentage of readings within a specific range). Instead, the submission relies on demonstrating substantial equivalence to a predicate device (GlucoLeader™ Value Self-Monitoring of Blood Glucose System) through strong correlation.
Therefore, the "acceptance criteria" inferred from the document is the demonstration of a strong linear correlation (R > 0.98) and low standard error of the estimate (Sy.x) within the specified glucose measurement range (40-400 mg/dL or 64-539 mg/dL) when compared to a reference method (YSI) for lay users and technicians, and when compared to the predicate device (GlucoLeader™ Value) in point-of-care settings.
| Performance Metric | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (GlucoLeader™ Enhance) |
|---|---|---|
| Consumer Study | ||
| Correlation (R) vs. YSI (Lay Users) | > 0.98 | 0.987 |
| Sy.x vs. YSI (Lay Users) | Low (relative to predicate/clinical needs) | 13.65205 |
| Range (Lay Users) | 40-400 mg/dL (or similar) | 64-539 mg/dL |
| Correlation (R) vs. YSI (Technician) | > 0.98 | 0.981 |
| Sy.x vs. YSI (Technician) | Low (relative to predicate/clinical needs) | 19.0268 |
| Range (Technician) | 40-400 mg/dL (or similar) | 68-539 mg/dL |
| Point-of-Care Study | ||
| Correlation (R) vs. GlucoLeader™ Value (Total) | > 0.98 | 0.986 |
| Sy.x vs. GlucoLeader™ Value (Total) | Low (relative to predicate/clinical needs) | 13.78 |
| Range (Total) | 40-400 mg/dL (or similar) | 68-411 mg/dL |
| Measuring Range | 30-600 mg/dL | 30-600 mg/dL (claimed to be similar to predicate) |
| Acceptable Hematocrit Range | 30-50 % | 30-50 % (claimed to be similar to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Consumer Study:
- Sample Size: 180 specimens for lay users and 180 specimens for technicians.
- Data Provenance: Conducted at "clinical centers." The country of origin is not explicitly stated, but the submitter is HMD Biomedical Inc. from Taiwan. The mention of "clinical centers" suggests a prospective collection for this study, though it's not explicitly stated as "prospective."
- Point-Of-Care Study:
- Sample Size: 150 specimens (50 each from Home Medical, Metabolism, and Internal departments).
- Data Provenance: Conducted at "department of Home Medical, Internal, and Metabolism." Similar to the consumer study, the country of origin is not explicitly stated. This appears to be prospective data collection in a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Ground Truth Method: The primary ground truth for the consumer study was established using the YSI (Yellow Springs Instruments) method, which is a laboratory reference method for glucose measurement. For the point-of-care study, the predicate device, GlucoLeader™ Value, served as the comparative reference.
- Experts: The document does not specify a "number of experts" in the context of establishing ground truth for the test set by consensus or interpretation (e.g., radiologists). The ground truth was primarily obtained via instrument-based reference methods (YSI) and the predicate device. For the "technician" comparison in the consumer study, it's implied that trained medical technicians operated the GlucoLeader Enhance device and that their readings were compared to the YSI reference. Their qualifications are not further detailed beyond "technician."
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by objective measurements from reference instruments (YSI) or by comparison to the predicate device, not through expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes studies to evaluate the standalone performance and substantial equivalence of a glucose meter, not a comparative effectiveness study involving multiple human readers using an AI vs. without AI assistance. The device is a self-monitoring blood glucose system, not an AI diagnostic tool that assists human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Yes, the studies presented are essentially standalone performance evaluations of the GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System.
- The "Consumer Study" compares the device's output (when used by lay users or technicians) directly against a definitive reference method (YSI).
- The "Point-of-Care Study" compares the device's output against a predicate device.
In both cases, the performance being assessed is that of the device itself.
7. Type of Ground Truth Used
- Consumer Study Ground Truth: Objective reference method measurements from a YSI instrument (a laboratory analyzer for glucose).
- Point-of-Care Study Ground Truth: Comparative measurements from the GlucoLeader™ Value predicate device.
8. Sample Size for the Training Set
The document does not provide any information about a "training set" or how the device's algorithms (if any beyond basic signal processing and conversion) were developed or trained. This submission focuses on the performance of a final, manufactured device. Glucose meters typically use pre-calibrated algorithms established during development, not "trained" in the machine learning sense on a distinct training dataset for each submission.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set information is provided or implied for this type of device in the document.
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GlucoLeuder™ Enhunce Self-Monitoring of Blovd Glucose System
September 2003 Special 510(k) Submission-September. 2003
| OCT 21 2003 | Special 510(k) Submission-September. 2003 |
|---|---|
| Special 510 (k) SUMMARY | |
| This summary of 510(k) safety and effectiveness information is being submitted in accordance with the | |
| requirements of SMDA 1990 and 21 CFR 807.92 | |
| The assigned 510(k) number is: K032985 | |
| Introduction: | According to the requirements of 21 CFR 862.1345, the |
| following information provides sufficient detail to understand the | |
| basis for a determination of substantial equivalence. | |
| Submitter: | HMD BIOMEDICAL, Inc. |
| Address: | 3 F, No. 324, Sec. 1, Chunghwa Rd. Hsinchu, Taiwan, 300 |
| Contact Number: | Phone: 886-3-5354630 |
| Fax:886-3-5354633 | |
| Contact Person: | Jeffery Fleishman |
| Official Correspondent | |
| Date Prepared: | Sep.10.2003 |
| Device Name: | |
| Proprietary name: | GlucoLeader™ Enhance Self-Monitoring of Blood Glucose |
| System | |
| Common name: | Glucose Meter |
| Classification name: | NBW (System, Test Blood Glucose, over the Counter) |
| Device Classification: | Glucose Test System per21 CFR 862.1345 |
| Class II Device | |
| Predicate Device: | |
| Name: | GlucoLeaderTM Value Self-Monitoring of Blood Glucose |
| System | |
| Manufacturer: | HMD BioMedical Inc. |
| 3 F, No. 324, Sec. 1, Chunghwa Rd. Hsinchu, Taiwan, 300 | |
| 510(k) Number: | K023279 |
·
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Test Principle:
The GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System is comprised of two main parts a bio-active electrode (test strip) containing the enzyme glucose oxidase and the glucose meter. The blood sample is drawn into the Test Strip through capillary action. Glucose in the sample reacts with glucose oxidase and potassium ferricyanide in the strip, ferrocyanide. Potassium producing ferrocyanide is produced in proportion to the glucose concentration of the blood sample .Oxidation of the potassium ferrocyanide produces an electrical current which is then converted by the meter to display the glucose concentration.
The GlucoLeader Enhance Self-Monitoring of Blood Intended Use: Glucose 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, this device is not suitable for neonate samples. Similarities:
The proposed modification is relatively modest in scope. All of the following are claims and features unaffected by the proposed modification
| Feature/Claim | Detail |
|---|---|
| Intended Use | The GlucoLeader Enhance Self-Monitoring of BloodGlucose System is intended for the quantitative measurementof glucose in fresh capillary whole blood. Testing is doneoutside the body (in vitro diagnostic use). It is indicated foruse at home (over the counter [OTC]) by persons withdiabetes, this device is not suitable for neonate samples. |
| Test Principle | The GlucoLeader Enhance Self-Monitoring of BloodGlucose System is base on the measurement of electricalcurrent caused by the reaction of glucose with the reagent(Glucose Oxidase method) on the electrode of the strip. |
| Warnings and Precautions | For in-vitro diagnostic use only |
| Specimen Type | Capillary whole blood |
| Sample volume | Both need 3uL capillary whole blood |
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| Measuring Time | Both within 15 seconds |
|---|---|
| System Performance | Both use two levels quality control solution to check systemperformance. |
| Measuring Range | Both in 30~600 mg/dL |
| Acceptable Hematocrit Range | 30-50 % |
Differences:
| Feature | GlucoLeader™ EnhanceSelf-Monitoring of BloodGlucose System(modified) | GlucoLeader™ ValueSelf-Monitoring of BloodGlucose System(predicate) |
|---|---|---|
| Meter Dimension | 95 (L)*60 (W)*18.5(H)mm | 93(L)*38(W)*18(H)mm |
| Weight | Approximate 70g (withbattery) | Approximate 30g(withbattery) |
| Electrics voltage | 0.15V | 0.41V |
| Measuring current limited | 50μA | 75μA |
| Button | Left: Function keyRight: Memory, Setting key | No button |
| Setting function | Setting date, time and unit | NA |
| Data download | Test results can download byRS232 interface | NA |
| Average result with memory | Calculate mean results within7,14,21 and 28 days | NA |
| Ready to test symbol. | User can apply blood to thestrip after theImage: displayon LCD. | User can apply blood tothe strip after the 「bLd」display on LCD |
| Flashing strip symbol | Press any button to poweron, the code number andImage: flashing strip symbolwill display | NA |
The detail differences listing are shown on "Substantial Equivalent Table".
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Data The results conducted at consumer and point-of-care studies demonstrated consistent quality performance of. GlucoLeader"™ Enhance Demonstrating substantial Self-Monitoring of Blood Glucose System. These study demonstrated good correlation(R>0.98) between 40~400 mg/dl of capillary whole blood equivalence: specimens. With these data it is proved that the regression analysis of the system is equivalent predicate device
Consumer Study
Linear regression between GlucoLeader Enhance (GEB) and YSI for lay users and technician
| Accuracy of lay users compared to YSIusing capillary whole blood on 180specimens at clinical centers | N=180Y=0.9684X+2.3058R=0.987Sy.x=13.65205Range=64-539mg/dL |
|---|---|
| Accuracy of technician compared to YSIusing capillary whole blood on 180specimens at clinical centers | N=180Y=0.9934X-2.3866R=0.981Sy.x=19.0268Range=68-539mg/dL |
Point-Of-Care Study
Linear regression between GlucoLeader Enhance (GEB) and GlucoLeader Value (GVA) for test on department of Home Medical, Internal, and Metabolism
| Home Medical | Metabolism | Internal | Total |
|---|---|---|---|
| N=50 | N=50 | N=50 | N=150 |
| Y=0.969X+6.82 | Y=0.9168X+8.87 | Y=0.9982X-6.57 | Y=0.9573X+4.37 |
| R=0.989 | R=0.986 | R=0.982 | R=0.986 |
| Sy.x=12.65 | Sy.x=10.36 | Sy.x=16.49 | Sy.x=13.78 |
| Range=68-388mg/dL | Range=71-298mg/dL | Range=72-411mg/dL | Range=68-411mg/dL |
Conclusion:
According to the tests consisted of system function, hardware, software, packaging, electrical safety and laboratory, clinical evaluations, these design modified can be verified and validated demonstrating that the performance of the GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System will not affected safety and effectiveness.
Test demonstrated that the performance of the GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System was substantially equivalent to predicate device
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
HMD BIOMEDICAL, INC. c/o Mr. Jeffery Fleishman Official Correspondent Immunostics, Inc. 3505 Sunset Avenue Ocean, NJ 07712
OCT 2 1 2003
Re: K032985
Trade/Device Name: GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW: CGA Dated: September 22, 2003 Received: September 24, 2003
Dear Mr. Fleishman:
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, listing 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 (OS) regulation (21 CFR Part 820).
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Page 2 -
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 Butman
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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INDICATION FOR USE STATEMENT
510(k) Number (if known): (032985
Device Name:
GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System
Indications for Use: The GlucoLeader Enhance Self-Monitoring of Blood Glucose 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.
Carol PC Benson for Dean Cooper, DVM
Division Sign-Off
ice of In Vitro Diagnostic Device luation and Sa 510(k) K03 2 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Over-the-Counter Use
(Per 21 CFR 801.109)
§ 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.