(121 days)
The EUSURE Blood Glucose Monitoring System is designed to measure the blood glucose levels in capillary whole blood. The system is suitable for diabetic patients to monitor their blood glucose levels at home by themselves. The system can also be used at clinical sites by health care professionals to test the blood glucose levels of patients. The test range is from 30 mg/dL to 600 mg/dL ( 1.67 -3.33 mmol/L).
Based on an electrochemical biosensor technology and the principle of capillary action, ENSURE system only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and is displayed in 15 seconds.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EUSURE Blood Glucose Monitoring System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for performance metrics like accuracy, precision, or other relevant blood glucose monitoring system specifications. It also does not provide detailed reported device performance data beyond stating that the system "precisely" displays results.
The document primarily focuses on establishing Substantial Equivalence (SE) to a predicate device (Apex Biotechnology Corp. -- glucosure blood glucose monitoring system, K002621). The claim of SE is based on shared working principles and technologies, with noted differences being electric voltage, dimensions, and weight, none of which are deemed to impact safety and effectiveness.
Therefore, the table below reflects the implicit acceptance criteria based on substantial equivalence and the general statements made in the document.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Substantial Equivalence to Predicate Device (K002621): Shared working principle and technologies, no safety/effectiveness aspects arising from differences. | "Claim of substantial equivalence is made to Apex Biotechnology Corp. - glucosure blood glucose monitoring system (K002621). Both of them have the same working principle and technologies. The differences are electric voltage, dimensions of the unit and strip, weight. There are no safety and effectiveness aspects arising from the subject device." |
| Intended Use Fulfilled: To measure glucose in whole blood for self-monitoring by diabetics at home and by professionals at clinical sites. Test range of 30-600 mg/dL (1.67-33.3 mmol/L). | "The EUSURE® glucose test strip is intended to measure the glucose in whole blood with the EUSURE® glucose meter. It is suitable for a person with diabetes to monitor their blood glucose at home by themselves. The system can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood." "The test range is from 30 mg/dL to 600 mg/dL (1.67 -3.33 mmol/L)." (Note: Typo in mmol/L conversion in original document, 33.3 mmol/L is likely intended for 600 mg/dL). |
| Accuracy/Precision (General Statement): Precise results. | "your blood glucose result is precisely and displayed in 15 seconds." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA."
However, the specific sample size used for the test set is NOT provided, nor is the data provenance (e.g., country of origin, retrospective/prospective) detailed within the excerpt.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is NOT provided in the excerpt. The document doesn't detail how ground truth was established for any clinical data.
4. Adjudication Method for the Test Set
This information is NOT provided in the excerpt.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and its effect size
An MRMC comparative effectiveness study is NOT mentioned in the document. The study described is for device clearance based on substantial equivalence to a predicate device, not a comparative effectiveness study involving human readers with/without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The EUSURE Blood Glucose Monitoring System is a medical device (meter and test strips), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance does not apply in this context and is not discussed. The device itself is the standalone system for measurement.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any clinical data. For blood glucose monitoring systems, ground truth is typically established using a reference laboratory method (e.g., YSI analyzer) which is considered highly accurate, rather than expert consensus, pathology, or outcomes data. Given the context, it's highly probable that such a reference method was used for any clinical performance evaluations, but this is an assumption based on typical practices for these devices.
8. The Sample Size for the Training Set
The document does not refer to a "training set" in the context of machine learning. The device is an electrochemical biosensor system, not a software algorithm that would typically undergo training with a separate dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" in the context of an AI/ML algorithm, this question is not applicable.
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'JUL 1 4 2004
510(K) Summary of Safety and Effectiveness II.
(Per 21 CFR 807.92)
2.1. General Information Establishment
| Manufacturer: | EUMED BIOTECHNOLOGY CO., LTD. |
|---|---|
| Address: | 3F, NO. 789, BOAI ST. |
| HSIN CHU HSIEN, China (Taiwan) 302 | |
| Registration Number: | 3004379419 |
| Contact Person: | Dr. Ke-Min Jen |
| Official Correspondent | |
| 886-3-5208829 (Tel) | |
| 886-3-5209783 (Fax) | |
| Date Prepared: | March 11, 2004 |
| Device | |
| Proprietary Name: | EUSURE, EUGLUCO |
| Common Name: | Blood Glucose Monitoring System |
| Classification Name: | SYSTEM, TEST, BLOOD GLUCOSE,OVER THE COUNTER, Class II. |
2.2. Safety and Effectiveness Information
-
. Predicate Device:
Claim of Substantial Equivalence (SE) is made to Apex Biotechnology Corp. -- glucosure blood glucose monitoring system (K002621) -
Device Description: Based on an electrochemical biosensor technology and the principle of capillary action, ENSURE system only needs a small amount of blood. Capillary action at the end of the test strip draws the
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blood into the action chamber and your blood glucose result is precisely and displayed in 15 seconds.
Intended Use: ●
The EUSURE® glucose test strip is intended to measure the glucose in whole blood with the EUSURE® glucose meter. It is suitable for a person with diabetes to monitor their blood glucose at home by themselves. The system can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood.
Synopsis of Test Methods and Results ●
Pre-clinical and clinical data are employed upon submission of this 510(K) premarket notification according to the Guidance Document for In Vitro Diagnostic Test System; Guidance for Industry and FDA document provided by CDRH/ FDA.
Substantial Equivalence (SE) ●
A claim of substantial equivalence is made to Apex Biotechnology Corp. -glucosure blood glucose monitoring system (K002621). Both of them have the same working principle and technologies. The differences are electric voltage, dimensions of the unit and strip, weight. There are no safety and effectiveness aspects arising from the subject device. They are substantially equivalent.
Ke-Rin Jen
Ke-Min Jen, Dr. Official Correspondent for eumed biotechnology co., ltd.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 4 2004
Mr. Ke-Min Jen Official Correspondent Eumed Biotechnology Co., Ltd. 3F, NO. 789, Boai St. Hsin Chu Hsien, China (Taiwan) 302
K040678 Re:
Trade/Device Name: EUSURE® Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: July 2, 2004 Received: July 9, 2004
Dear Mr. Jen:
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 (QS) 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,
Seain M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
K040678 510(k) Number:
EUSURE blood glucose monitoring system Device Name:
Indications For Use:
The EUSURE Blood Glucose Monitoring System is designed to measure the blood glucose levels in capillary whole blood. The system is suitable for diabetic patients to monitor their blood glucose levels at home by themselves. The system can also be used at clinical sites by health care professionals to test the blood glucose levels of patients. The test range is from 30 mg/dL to 600 mg/dL ( 1.67 -3.33 mmol/L).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Page 1 of 1
Office of In Vitro Diagno
510(K) K040678
§ 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.