(181 days)
No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No
The device is an in vitro diagnostic device used for monitoring blood glucose levels, not for directly treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is used "to measure Glucose (sugar) in the whole blood" and is for "monitoring blood glucose levels for better glucose level control among diabetics," which are diagnostic purposes. It also specifies "in vitro diagnostic use."
No
The device description explicitly mentions "EZ Smart Blood Glucose Test Strips" and the "EZ Smart Meter," which are hardware components necessary for measuring glucose. The summary describes a system that includes physical test strips and a meter, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The provided text explicitly states:
- "The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use)."
- "The EZ Smart 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."
These statements clearly indicate that the device is designed to perform diagnostic testing on samples taken from the body (blood) outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in the whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use). The EZ Smart 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 Blood Glucose Monitoring System is indicated for use with capillary whole blood samples drawn from the fingertips and forearm.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use ). The EZ Smart 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip and forearm
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)
There has been no change to the performance characteristics of the device system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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510(k) Summary
for
EZ Smart Blood Glucose Monitoring System New 510(k) For Additional Labeling And Indication For Alternative Site Testing
1. DATE PREPARED
December 3, 2004
2. SPONSOR INFORMATION
Address
VIP Diagnostics LLC 1796 Clove Road Staten Island, NY 10304
Contact Person: George P. Drogaris, MS R.Ph.
(800) 566-3480 (telephone) (718) 390-0473 (facsimile)
Outside Regulatory Counsel
Foley & Lardner LLP 3000 K St., NW Suite 500 Washington, DC 20007
Contact Person: David L. Rosen, B.S.Pharm., J.D.
(202) 672-5430 (telephone) (202) 672-5399 (facsimile)
3. DEVICE NAME
| Proprietary Name: | EZ Smart Blood Glucose Monitoring System |
|---|---|
| Common/Usual Name: | Blood Glucose Monitoring System |
| Classification Name: | Glucose Test System (per 21 C.F.R § 862.1345 (2003)) |
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4. DEVICE DESCRIPTION AND INTENDED USE
The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use ). The EZ Smart 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 Blood Glucose Monitoring System is indicated for use with capillary whole blood samples drawn from the fingertip and forearm.
5. PREDICATE DEVICE
-
Predicate device name 1.
EZ Smart Blood Glucose Monitoring System Bayer Elite XL with the Elite Test Strips Baver Elite with the Elite Test Strips -
Predicate K Number 2.
K040848 (EZ Smart) K984006 (Bayer Elite XL) K964630 (Bayer Elite) K991242 (Bayer Elite Test Strips) -
Substantial Equivalence Comparison 3.
The modifications to the device encompass labeling changes only. There has been no changed to the intended use, fundamental scientific technology, physical design, operating principles, functionality or material composition of the device systems.
Modified labeling additions to EZ Smart:
Note: Alternative Site Testing Note: Incential.re brofessional prior to testing from a site other than vour fingertips.
Under certain conditions, blood glucose testing results from sites other than your fingertip may be significantly different. These differences may vary from
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individual to individual, and are physiological differences caused by factors such as food intake, health state and medication being used.
The conditions in which these differences are more likely to occur are when your I the conditions in maging rapidly such as following a meal, an insulin dose, or associated with physical exercise. When blood glucose is changing rapidly, associated with piry creat ense changes more quickly than other sample sites.
Use alternative test sites only for testing prior to, or more than two hours after meals, insulin dose, or physical exercise.
You should also use fingertip testing whenever you have a concern about 1 ou should also ass in relations) such as when driving a car, particularly if you nypog.fyouma (insuceness, as alternative site testing may fail to detect hypoglycemia.
If you perform testing other than from a fingertip (such as the forearm):
A. Select a soft, fleshy area of skin that is free from hair and visible veins.
B. Wash the puncture site with soap and warm water. Rinse and dry thoroughly. This ensures cleanliness and increases blood flow to the puncture site.
C. After you have determined the proper depth of your selected site, set the lancing device for that depth of puncture. Firmly press the lancing device against the skin at the selected lancing site, then press the button to lance the skin. When the skin at the belows on the surface of your skin, bring the meter and test strip up to touch the drop.
ટી.
PERFORMANCE CHARACTERISTIC SUMMARY 6.
There has been no change to the performance characteristics of the device system.
TECHNOLOGICAL CHARACTERISTICS 7.
There has been no changes to the fundamental scientific technology.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized symbol. The symbol is a stylized representation of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
JUN 2 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
VIP International Wholesales, Corp. c/o David L. Rosen, B.S. Pharm., J.D. Foley & Lardner LLP 3000 K Street, NW, Suite 500 Washington, DC 20007-5143
Re: K043340
Trade/Device Name: EZ Smart Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: April 11, 2005 Received: April 11, 2005
Dear Mr. Rosen:
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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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,
Carol C. Benam
Carol C. Benson, M.A. Acting 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
| 510(k) Number: | K 043340 |
|---|---|
| Device Name: | EZ Smart Blood Glucose Monitoring System |
| Indications For Use: | The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in the whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use). The EZ Smart 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 Blood Glucose Monitoring System is indicated for use with capillary whole blood samples drawn from the fingertips and forearm. |
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)
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