(255 days)
The EZ Smart-168 Blood Glucose Test Strips are used with the EZ Smart-168 Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The EZ Smart-168 Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Smart-168 Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels in persons with diabetes.
Based on an electrochemical biosensor technology and the principle of capillary action, EZ SMART-168 Glucose Monitoring 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 10 seconds, and 28 blood glucose result memory.
The provided 510(k) summary for the EZ SMART-168 Blood Glucose Monitoring System (K052818) does not contain detailed information about specific acceptance criteria and the comprehensive study that proves the device meets them, as requested.
The document primarily focuses on establishing substantial equivalence to a predicate device (EZ SMART Blood Glucose Monitoring System, K040848) based on having the "same working principle and technologies" and "identical" test strips, with only minor changes to meter coding and memory size for convenience.
However, based on the information provided, here's what can be extracted and what is missing:
Description of Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria
The submission states that "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 details of these tests and their specific acceptance criteria are not included in this summary.
Missing Information:
- Specific quantitative acceptance criteria (e.g., accuracy percentages, bias targets, precision limits).
- Details of the clinical and pre-clinical studies performed.
- The actual results of these studies demonstrating conformance to specific criteria.
Extracted and Inferred Information (with limitations):
1. Table of Acceptance Criteria and Reported Device Performance
This information is NOT present in the provided document.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
This information is NOT present in the provided document.
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is NOT present in the provided document.
- Since this is a blood glucose monitoring system, the "ground truth" would typically be established by a reference laboratory method (e.g., YSI analyzer) rather than expert consensus on images. Therefore, the concept of "experts" in this context is likely not applicable in the way it would be for imaging diagnostics. The qualifications of lab personnel operating reference instruments are also not provided.
4. Adjudication Method for the Test Set
This information is NOT present in the provided document.
- Given it's a blood glucose device, adjudication methods like 2+1 or 3+1 (common in image interpretation) are not relevant. If there were discrepancies in reference measurements, standard lab protocols for re-testing or averaging would be used, but these details are not supplied.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This information is NOT applicable and NOT present in the provided document.
- MRMC studies are typically for diagnostic imaging devices where human readers interpret images with or without AI assistance. This device is a quantitative blood glucose monitor where human interpretation of results is direct.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This information is mostly inferred but not explicitly detailed.
- Blood glucose meters inherently operate in a "standalone" fashion in terms of generating a numerical result from a sample. The device is designed to measure glucose in whole blood and display the result. The performance data would therefore represent the algorithm's (device's) ability to do this accurately and precisely. The document explicitly states: "EZ SMART-168 Glucose Monitoring 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 displayed in 10 seconds, and 28 blood glucose result memory." This describes the standalone operation of the device.
7. The Type of Ground Truth Used
This information is NOT explicitly stated in the provided document but can be inferred based on the device type.
- For blood glucose monitoring systems, the ground truth is almost universally established by laboratory reference methods, such as a YSI glucose analyzer or another highly accurate and precise laboratory instrument. This constitutes a form of "outcomes data" or highly reliable direct measurement, against which the device's measurements are compared.
8. The Sample Size for the Training Set
This information is NOT present in the provided document.
- Blood glucose meters, especially older models like this one (2006), typically rely on well-established electrochemical biosensor technology. While a "training set" might be used during the development and calibration of the algorithms within the meter and the manufacturing of test strips, these details are usually proprietary and not included in 510(k) summaries, which focus on clinical performance validation rather than internal algorithm development data.
9. How the Ground Truth for the Training Set Was Established
This information is NOT present in the provided document.
- Similar to the test set, if a training set were explicitly discussed, its ground truth would likely be established by laboratory reference methods.
Conclusion:
The provided 510(k) summary primarily serves to establish substantial equivalence for the EZ SMART-168 Blood Glucose Monitoring System to a predicate device. It confirms the device's intended use and general working principle. However, it lacks the specific details regarding acceptance criteria, study methodologies, sample sizes, and detailed performance data that would be necessary to fully answer the request for a comprehensive description of the device's proven performance against specific criteria. These details would typically be found in more extensive regulatory submissions or in accompanying technical documentation, but they are not part of this summary document.
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JUN 16 2006
II. 510(K) Summary of Safety and Effectiveness
(Per 21 CFR 807.92)
2.1. General Information Establishment
| Manufacturer: | TYSON BIORESEARCH, INC. |
|---|---|
| Address: | 5F, No. 22, Ke Tung Rd., Science Based Industrial Park,Chun-Nan, Miao-Li County, 350, Taiwan |
| Registration Number: | 3003132490 |
| Contact Person: | Dr. Jen, Ke-MinConsultant886-3-5208829 (Tel)886-3-5209783 (Fax) |
| Date Submitted: | September 28, 2005 |
| Device | |
| Proprietary Name: | EZ SMART-168 Blood Glucose Monitoring System |
| Common Name: | Blood Glucose Monitoring System |
| Classification Name: | SYSTEM, TEST, BLOOD GLUCOSE, Class II |
2.2. Safety and Effectiveness Information
-
. Predicate Device:
Claim of Substantial Equivalence (SE) is made to VIP International Wholesalers, Corp. --EZ SMART Blood Glucose Monitoring System ( K040848 ). -
Device Description: . Based on an electrochemical biosensor technology and the principle of capillary action, EZ SMART-168 Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action
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chamber and your blood glucose result is precisely and displayed in 10 seconds, and 28 blood glucose result memory.
Intended Use: ●
The EZ SMART-168 Blood Glucose Test Strips are used with the EZ SMART-168 Meter to measure Glucose in whole blood. The EZ SMART-168 Test Strips are for testing outside the body ( in vitro diagnostic use ). The EZ SMART-168 Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics.
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 the predicate device VIP International Wholesalers, Corp. -- EZ SMART Blood Glucose Monitoring System ( K040848 ). Both of them have the same working principle and technologies. The EZ Smart-168 Test Strip is identical to the EZ Smart Test Strip. Only the meter coding method and memory size changes for more convenient operation of the EZ Smart Blood Glucose Monitoring System.
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Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text that reads 'U.S. Department of Health & Human Services'. Inside the circle is a stylized symbol resembling an eagle or bird in flight, depicted with curved lines. The logo is in black and white and appears to be a standard emblem for the U.S. Department of Health & Human Services.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tyson Bioresearch Inc. c/o Nathan A. Beaver, Esq. Foley and Lardner 3000 K Street NW Suite 500 Washington DC 20007
JUN 16 2006
Re: K052818
Trade/Device Name: EZ Smart-168 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: April 7, 2006 Received: April 11, 2006
Dear Mr. Beaver:
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 drive 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. Your 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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Gutt
Alberto Gutierrez, Ph.D. 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
K052818 510(k) Number:
EZ Smart-168 Blood Glucose Monitoring System Device Name:
Indications For Use:
The EZ Smart-168 Blood Glucose Test Strips are used with the EZ Smart-168 Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The EZ Smart-168 Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Smart-168 Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels in persons with diabetes.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use x (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 C. Benam
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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§ 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.