(370 days)
K071393, 5101597
Not Found
No
The document describes a standard blood glucose monitoring system and a data management application. There is no mention of AI, ML, or related technologies in the intended use, device description, or performance studies.
No.
The device is intended for "quantitative measurement of blood glucose levels" as an "aid to monitor the effectiveness of diabetes control," not for treatment.
No
The device is explicitly stated as "not for the diagnosis of, or screening for diabetes." Instead, it is an "aid to monitor the effectiveness of diabetes control."
No
The device description explicitly states the system consists of a blood glucose meter, test strips, and control solution, which are hardware components. While there is an optional software accessory, the core medical device is a hardware system.
Yes, the iBGStar™ Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is intended for self testing outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control."
- Function: The system measures blood glucose levels in blood samples, which is a classic example of an in vitro diagnostic test.
- Components: The system includes a meter, test strips, and control solutions, all typical components of an IVD system for blood glucose monitoring.
N/A
Intended Use / Indications for Use
The iBGStar™ Blood Glucose Monitoring System is Intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be used for testing multiple patients. The iBGStar™ Blood Glucose Monitoring System is intended for self testing outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iBGstar Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
The iBGStar Diabetes Manager Application is intended for use in the home with the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.
Product codes (comma separated list FDA assigned to the subject device)
CGA, JQP, NBW, JJX
Device Description
- The iBGStar Blood Glucose Monitoring System consists of: iBGStar Blood Glucose Meter 0 BGStar Test Strips .
- BGStar Control Solution 0
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palms (at the base of the thumb), or forearms
Indicated Patient Age Range
Not Found
Intended User / Care Setting
single patient, people with diabetes at home
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An evaluation of the iBGStar BGMS and iBGStar Diabetes Manager Application were studied in house and in a clinical setting by person with diabetes. The studies demonstrated the ease of operating the iBGStar BGMS and iBGStar Diabetes Manager Application as intended.
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.
K071393, 5101597
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.
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
AgaMatrix
K103544
DEC - 7 2011
Agati Matrix, Inc. • 70 Raymond Avenue • Salem, NH 03079 USA
510(k) Summary
This summary of 510k) safety and effectiveness information is being submitted in accordance with the requirements of SMFA 1990 and CFR 807.92.
| 510(k) Number: | K103544 |
|---|---|
| Prepared: | December 5, 2011 |
| Submitter: | AgaMatrix, Inc. |
| Address: | 7C Raymond Ave. |
| Salem, NH 03079 | |
| Phone: (603) 328-6000 | |
| Fax: (617) 588-0430 | |
| Contact: | William H. McGrail |
| Executive Director, Regulatory & Clinical Affairs | |
| Device Name: | Trade/Proprietary Name: iBGStar Blood Glucose Monitoring System |
| Common Name: Glucose Test System | |
| Product Name: iBGStar Diabetes Manager Application | |
| Common Name: Diabetes Management Software |
Device Classification:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| CGA - glucose Oxidase | Class II | 21 CFR 862.1345 | 75, Clinical Chemistry |
| NBW - system, test, blood | |||
| glucose, over the counter | Class II | 21 CFR 862.1345 | 75, Clinical Chemistry |
| JJX - Quality Control Material | Class I | 21 CFR 862.1660 | 75, Clinical Chemistry |
| JQP - Calculator/data processing | |||
| module for clinical use. | Class 1 | 21 CFR 862.2100 | 75, Clinical Chemistry |
Predicate Device:
- Jazz Blood Glucose Monitoring System, 510(k) # K071393 2) WaveSense Diabetes Manager, 510(k) # 5101597
Device Description:
- The iBGStar Blood Glucose Monitoring System consists of: iBGStar Blood Glucose Meter 0 BGStar Test Strips .
- BGStar Control Solution 0
Page 1 of 3
Salem, New Hampshire 03079 USA
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Intended Use:
The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be used for testing multiple patients. The iBGStar™ Blood Glucose Monitoring System is intended for self testing outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iBGstar Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
The iBGStar Diabetes Manager Application is intended for use in the home with the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.
Technological Characteristics:
There were no changes to the fundamental scientific technology.
Comparison to Predicate:
| Item | Jazz BGMS | iBGStar BGMS |
|---|---|---|
| Indications for Use | Blood glucose monitoring | Same |
| Intended Use | Home Use | Same |
| Calibration | No coding required | Same |
| Test Principle/Enzyme | Glucose Oxidase | Same |
| System Characteristics | Operating Temp, Test Time, | |
| Test Range, Sample Size, Test | ||
| strips | Same |
- The iBGStar BGMS has the following similarities to the predicate device:
The iBGStar BGMS has the following differences from the predicate device:
| Item | Jazz BGMS | iBGStar BGMS |
|---|---|---|
| Backlight | Yes | No |
| Number of results stored | 1865 | 300 |
| Power Source | Two (2) CR-2032, 3 volt, | Polymer lithium-ion |
| Size | L-84 mm, W-46 mm, H-19.5 | L-56 mm, W-24 mm, H-10 |
| Weight | 48g | 8.5g |
Agamatrix, Inc. 7C Raymond Avenue
Salem, New Hampshire 03079 USA
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Image /page/2/Picture/0 description: The image shows the word "AgaMatrix" in a stylized font. The letters are slightly faded, giving the word a textured appearance. Above the "ix" in "Matrix", there is a curved line of dots, adding a decorative element to the logo.
C Raymond Avenue · Salem, NH 03079 US,
| Item | WaveSense Diabetes Manager app
(predicate device) | iBGStar Diabetes
Manager app |
|---------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------|
| Indications for Use | Download glucose readings to a data
management system to aid in the
effective management of diabetes. | Same |
| Intended Use | Home Use | Same |
| Management Tools | Logbook and Trend Charts | Same |
- The iBGStar Diabetes Manager app has the following similarities to the predicate device:
The iBGStar Diabetes Manager app has the following differences from the predicate device:
| Item | WaveSense Diabetes | iBGStar Diabetes Manager app |
|---|---|---|
| Upload To | PC (computer) | Device compatible with the iPhone Operating |
| System platform | ||
| Transfer of Glucose Readings | Cable Download | The iBGStar meter directly connects to idevice |
Assessment of Performance:
An evaluation of the iBGStar BGMS and iBGStar Diabetes Manager Application were studied in house and in a clinical setting by person with diabetes. The studies demonstrated the ease of operating the iBGStar BGMS and iBGStar Diabetes Manager Application as intended.
Conclusion:
The results of clinical evaluations of the iBGStar BGMS and the iBGStar Diabetes Manager app demonstrate the meter and application are equivalent in performance to the predicate devices and suitable for its intended use.
- 328 600
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a family. The profiles are rendered in a dark blue color.
10903 New Hampshire Avenue Silver Spring, MD 20993
AgaMatrix, Inc. c/o William McGrail 7C Raymond Ave Salem. NH 03079
JAN 1 1 2012
Re: K103544
Trade Name: iBGStar Blood Glucose Monitoring System, iBGStar Diabetes Manager Application, BGStar Control Solutions Regulation Number: 21 CFR 8862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: CGA, JQP, NBW, JJX Dated: November 23. 2011 Received: November 25, 2011
Dear Mr. McGrail:
This letter corrects our letter of December 7, 2011.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours.
N
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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AgaMatrix, Inc. 70 Raymond Ave Sakm, NH 03079 USA
Indications for Use
510(k) Number (if known): . K103544
Device Name: iBGStar Blood Glucose Monitoring System, iBGStar Diabetes Manager Application
Indications for Use:
The iBGStar™ Blood Glucose Monitoring
The iBGStar™ Blood Glucose Monitoring System is Intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be used for testing multiple patients. The iBGStar™ Blood Glucose Monitoring System is intended for self testing outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iBGstar Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
BGStar™ Test Strips
BGStar™ Test Strips are for use with the iBGStar™ Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. Palm and foream testing (Alternative Site Testing) should be done only during steady-state times (when glucose is not changing rapidly).
BGStar Control Solutions
BGStar Control Solutions are for use with the iBGStar™ Blood Glucose Meter and BGStar Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The iBGStar Diabetes Manager Application - Home Use
The iBGStar Diabetes Manager Application is intended for use in the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k): K103544