(255 days)
Not Found
No
The description focuses on electrochemical biosensor technology and capillary action for glucose measurement, with no mention of AI or ML.
No.
This device is an in-vitro diagnostic (IVD) device used to measure glucose levels, not to provide therapy or treatment.
Yes
The device "quantitatively measur[es] glucose (sugar) in fresh capillary whole blood" to "monitor blood glucose levels in persons with diabetes," which is a diagnostic purpose.
No
The device description explicitly mentions "EZ Smart-168 Blood Glucose Meter" and "EZ SMART-168 Glucose Monitoring System," which are hardware components. The test strips also rely on electrochemical biosensor technology and capillary action, indicating a physical, non-software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The EZ Smart-168 Test Strips are for testing outside the body (in vitro diagnostic use)."
- Definition of IVD: An in vitro diagnostic device is a medical device that is used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. This device fits this definition as it tests blood for glucose levels.
- Purpose: The device is intended for "quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip," which is a diagnostic measurement performed outside the body.
N/A
Intended Use / Indications for 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.
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.
Product codes
NBW, CGA, JJX
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 chamber and your blood glucose result is precisely and displayed in 10 seconds, and 28 blood glucose result memory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip (for blood sample collection)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home and in the professional settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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-Min |
| Consultant | |
| 886-3-5208829 (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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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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