(132 days)
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No
The document describes a standard blood glucose monitoring system using test strips and a meter, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No
The device is for monitoring blood glucose levels, not for treating a condition, making it a diagnostic device rather than a therapeutic one.
Yes
The device is explicitly stated to be for "in vitro diagnostic use" and is intended to "monitor blood glucose levels," which falls under the definition of diagnosing or monitoring a medical condition (diabetes in this case).
No
The device description explicitly mentions "EZ Smart Blood Glucose Test Strips" and "EZ Smart Blood Glucose Meter," which are hardware components. The 510(k) summary focuses on the performance of these physical components in measuring blood glucose.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use)."
- "The EZ Smart Test Strips are for testing outside the body (in vitro diagnostic use)."
This repeated statement, along with the description of measuring glucose in whole blood outside the body, clearly indicates that the device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Blood Glucose 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 professional settings to monitor blood glucose levels. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Indications For Use:
The EZ Smart Blood Glucose Test Strips are uses with the EZ Smart Meter to measure Glucose (sugar) in whole blood. The EZ Smart Test strips are for testing outside the Glasse (vegaliagnostic 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.
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 Blood Glucose Meter to measure glucose (sugar) in whole blood. The EZ Smart Test Strips are for testing outside the body (in vitro diagnostic use).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
the home and in professional settings
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An evaluation of the EZ Smart was conducted under various conditions including temperature effects, hematocrit levels, sensitivity and linearity, and presence of interferences. The results of the evaluation demonstrate that the EZ Smart is equivalent in performance to the predicate device and suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
0
AUG 11 2004
510(k) Summary
for
EZ Smart Blood Glucose Monitoring System
1. DATE PREPARED
March 29, 2004
2. SPONSOR INFORMATION
Address
VIP International Wholesalers, Corp. 1860 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
Gray Cary Ware & Freidenrich LLP 1625 Massachusetts Ave., NW Suite 300 Washington, DC 20036
Contact Person: David L. Rosen, B.S. Pharm., J.D.
(202) 238-7749 (telephone) (202) 238-7701 (facsimile)
3. DEVICE NAME
EZ Smart Blood Glucose Monitoring Proprietary Name: System
1
| Common/Usual Name: | Blood Glucose Monitoring
System |
|----------------------|---------------------------------------------------------|
| Classification Name: | Glucose Test System (per 21 C.F.R §
862.1345 (2003)) |
4. DEVICE DESCRIPTION AND INTENDED USE
The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Blood Glucose 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 professional settings to monitor blood glucose levels. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
5. PREDICATE DEVICE
- Predicate device name 1. Bayer Elite with the Elite Test Strips
- Predicate K Number 2. K964630 (Bayer Elite) K991242 (Bayer Elite Test Strips)
Substantial Equivalence Comparison 3.
| Item | Predicate Device
Bayer ELITE (K964630) | Proposed Device
EZ Smart |
|--------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Similarities | 1. Monitors glucose using
whole blood. | 1. Monitors glucose using
whole blood. |
| | 2. Directly displays results
without requiring
calculation. | 2. Directly displays results
without requiring
calculation. |
| | 3. Test principle includes
measuring a current
produced by a chemical
reaction. | 3. Test principle includes
measuring a current
produced by a chemical
reaction. |
| | 4. Test principle: Uses
glucose oxidase reaction. | 4. Test principle: Uses
glucose oxidase reaction. |
| | 5. Measuring range:
20 to 600mg/dL. | 5. Measuring range:
20 to 600mg/dL. |
2
| Differences | ELITE | EZ Smart |
|---|---|---|
| 1. Size: 97.8 x 56 x 14.5 mm |
- Measuring time: 30 seconds | 1. Size: 94 x 49 x 17 mm.
- Measuring time: 10 seconds. |
6. PERFORMANCE CHARACTERISTIC SUMMARY
An evaluation of the EZ Smart was conducted under various conditions including temperature effects, hematocrit levels, sensitivity and linearity, and presence of interferences. The results of the evaluation demonstrate that the EZ Smart is equivalent in performance to the predicate device and suitable for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of the text, which is arranged in a circular pattern around the bird. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
AUG 11 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
VIP International Wholesalers, Corp. c/o David Rosen 1625 Massachusetts Avenue NW Suite 300 Washington, DC 20036-2247
K040848 Re:
K040046
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: July 16, 2004 Received: July16, 2004
Dear Mr. Rosen:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premaince is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manatisa provice Amendments, or to commerce prof to May 26, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been icclassified in accoraanse what a proval application (PMA). and Cosmetic Act (Act) that to not require subject to the general controls provisions of the Act. The You may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (360 a00 v) into . Existing major regulations affecting your device il may be subject to such additional controllar contractions (CFR), Parts 800 to 895. In addition, FDA can be found in Thic 21, Code of I concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualles or a cosence complies with other requirements of the Act that I DA has made a decorminations administered by other Federal agencies. You must of any I cuclar statutes and regarations and limited to: registration and listing (21 Compry with an the Free 5 require 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) I mis lotter will and w yourse FDA finding of substantial equivalence of your device to a legally promatication of 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, If you desire upomotion 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 I va inal 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,
Sean M. Cooper, US, 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
5
Indications for Use
K040848 510(k) Number:
Device Name: EZ Smart Blood Glucose Monitoring System
Indications For Use:
The EZ Smart Blood Glucose Test Strips are uses with the EZ Smart Meter to measure Glucose (sugar) in whole blood. The EZ Smart Test strips are for testing outside the Glasse (vegaliagnostic 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.
George P. Dungan R.Ph., M.S.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ves (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
Division Sign-Off
Page 1 of
e of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040848