(297 days)
Not Found
No
The description focuses on electrochemical measurement of glucose and does not mention any AI/ML components or algorithms.
No.
The device is an in vitro diagnostic device used to measure glucose levels, not to treat or cure a medical condition.
Yes
The text explicitly states "The G4™ Monitor is an in vitro diagnostic device" and describes its purpose as measuring glucose levels to aid in monitoring diabetes management. The "Intended Use / Indications for Use" section also confirms its role in diagnosing and monitoring a medical condition.
No
The device description explicitly mentions a "G4™ Meter" and "G4™ Test Strips," which are hardware components used for measuring glucose. The principle of the test involves an electrochemical reaction measured by the meter. This indicates the device is a hardware-based system, not software-only.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "G4™ System is for testing outside the body (in vitro diagnostic use only)."
- Device Description: The "Device Description" section also states: "The G4TM Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in capillary whole blood..." and "This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood."
- Nature of the Test: The device measures glucose levels in a biological sample (capillary whole blood) outside of the body to aid in the diagnosis and monitoring of a medical condition (diabetes). This is the core definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The G4TM Diabetes Monitoring System is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4TM System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the forearm giving it an attractive, nearly painless alternative to the more painful fingertip site. The G4TM Control Solutions are a red liquid which is to be used to check that both the G4TM meter and G4TM test strips are working together properly. It contains a known range of glucose as specified on the vial.
The G4TM Meter device is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4TM System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm.
The G4TM Test Strips is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4TM System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm.
The G4TM Control Solutions are a red liquid which is to be used to check that both the G4TM meter and G4TM test strips are working together properly. It contains a known range of glucose as specified on the vial.
Product codes
NBW, CGA, JJX
Device Description
The G4TM Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in capillary whole blood, which is used with the G4TM Test Strips.
The test principle is: This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Capillary whole blood (fingertip testing, alternate site testing on the forearm/arm)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and in clinical 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)
Not Found
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 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
APR 14 2006
510(k) SUMMARY (As required by 21.CFR.807.92)
| Introduction: | According to the requirements of 21 CFR.807.92, the following
information provides sufficient data to understand the basis for a
determination of substantial equivalence. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | US Diagnostics, Inc.,
304 Park Avenue South
Suite 218
New York, NY 10010 |
| Contact Person: | Edward Letko
Phone: 917-402-5900
Fax: 212-202-5173 |
| Date Summary,
Prepared: | March 07, 2006 |
| Device Name: | Propriety Name: G4TM
Common Name: Blood Glucose Test System
Classification Name: Class II, 862.1345 Glucose Blood Tester |
| Predicate Device: | We claim substantial equivalence to the LifeScan, Inc.,
OneTouch® Ultra®. |
| Device
Description: | The G4TM Monitor is an in vitro diagnostic device designed for
measuring the concentration of glucose in capillary whole blood, which
is used with the G4TM Test Strips. |
| | The test principle is: |
| | This device is an in vitro diagnostic product intended for the
measurement of glucose concentration in human blood. The principle of
the test relies upon a specific type of glucose in the blood sample, the
dehydrogenase glucose that reacts to electrodes in the test strip. The test
strip employs an electrochemical signal generating an electrical current
that will stimulate a chemical reaction. This reaction is measured by the
Meter and displayed as your blood glucose result. |
| Intended Use: | The G4TM Diabetes Monitoring System is used for the quantitative
measurement of glucose level in capillary whole blood as an aid in
monitoring the effectiveness of diabetes management in the home and in
clinical settings. G4TM System is for |
| | testing outside the body (in vitro diagnostic use only). Testing sites
include the traditional fingertip testing along with alternate site
testing on the forearm giving it an attractive, nearly painless
alternative to the more painful fingertip site. The G4TM Control
Solutions are a red liquid which is to be used to check that both the
G4TM meter and G4TM test strips are working together properly. It
contains a known range of glucose as specified on the vial. |
| Comparison to | |
| Predicate Device: | The US Diagnostics, Inc. G4TM Module is substantially equivalent
to the other products in commercial distribution intended for
similar use. The most notable, it is substantially equivalent to the
currently marketed item, the OneTouch ® Ultra ® by LifeScan, Inc. |
| Conclusion: | The G4TM Blood Glucose Monitoring System is substantially
equivalent to the following predicate devices: K024194 –
LifeScan, Inc. OneTouch ® Ultra ®
K984261 – LifeScan, Inc. SURESTEP ®
K021513 – Roche Diagnostics Corp. Accu-Chek Advantage |
1
510(k) Summary, Continued
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo with a stylized bird-like symbol in black, set against a circular border. The border contains text, though the specific words are not legible due to the image's resolution. The bird-like symbol is composed of three curved lines that suggest wings or feathers, giving it a sense of motion or flight. The logo appears to be a seal or emblem, possibly representing an organization or institution.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Edward Letko Managing Director US Diagnostics, Inc. 304 Park Avenue South Suite 218 New York, NY 10010
APR 1 4 2006
Re: K051651
Trade/Device Name: G4™ Meter, G4™ Test Strips, G4™ Control Solutions Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: March 10, 2006 Received: March10, 2006
Dear Mr. Letko
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 cither 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 Eederal 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).
3
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,
Albete 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
4
Indications for Use
510(k) Number: K051651
Device Name: G4TM
Indications For Use: The G4™ Meter device is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm.
The G4™ Test Strips is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. G4™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm.
The G4™ Control Solutions are a red liquid which is to be used to check that both the G4TM meter and G4TM test strips are working together properly. It contains a known range of glucose as specified on the vial.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C.A.
Axon Signature
Page 1 of
Tice of In Vitro Diagnostic Devi-Anation and Cafaty
. L. G. S.
Confidential US Diagnostics, Inc.
4 12/2006