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 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 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 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.

Device Description

The iBGStar Blood Glucose Monitoring System consists of: iBGStar Blood Glucose Meter, BGStar Test Strips, BGStar Control Solution.

The iBGStar Diabetes Manager Application is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and supporting study details for the AgaMatrix iBGStar Blood Glucose Monitoring System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in a numerical format that would commonly be seen with diagnostic performance metrics (e.g., sensitivity, specificity, accuracy within a certain percentage). Instead, it focuses on demonstrating substantial equivalence to predicate devices.

However, the "Assessment of Performance" section implicitly identifies the core acceptance criteria as demonstrating ease of operating and performance equivalent to predicate devices for both the iBGStar Blood Glucose Monitoring System (BGMS) and the iBGStar Diabetes Manager Application.

Acceptance Criteria (Implicit from Submission)	Reported Device Performance (as stated in the document)
Ease of operating the iBGStar BGMS	Demonstrated ease of operating the iBGStar BGMS
Ease of operating the iBGStar Diabetes Manager Application	Demonstrated ease of operating the iBGStar Diabetes Manager Application
Performance equivalence to predicate devices for iBGStar BGMS	Clinical evaluations demonstrate the iBGStar BGMS is equivalent in performance to the predicate devices.
Performance equivalence to predicate devices for iBGStar Diabetes Manager Application	Clinical evaluations demonstrate the iBGStar Diabetes Manager app is equivalent in performance to the predicate devices.
Suitability for intended use	Demonstrated suitable for its intended use.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size used for the test set in a clinical study. It generally states a "clinical setting by person with diabetes." It does not provide information on the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a blood glucose monitoring system, the "ground truth" would typically come from a laboratory reference method, not expert consensus.

4. Adjudication Method for the Test Set

This information is not provided in the document, as the "ground truth" for a blood glucose device would not typically involve expert adjudication in the same way as, for instance, imaging interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this document. This type of study is more common for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated with and without AI assistance. This submission is for a blood glucose meter and accompanying software, not an interpretive AI system for diagnosis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The primary device (iBGStar Blood Glucose Monitoring System) is a standalone device that measures blood glucose. The iBGStar Diabetes Manager Application is software that processes and displays data from the blood glucose meter. The "Assessment of Performance" states that "An evaluation of the iBGStar BGMS and iBGStar Diabetes Manager Application were studied in house and in a clinical setting," implying that the performance of the device (BGMS) and the application (Diabetes Manager) were evaluated. The BGMS itself performs "algorithm only" measurements.

7. The Type of Ground Truth Used

While not explicitly stated, for a blood glucose monitoring system, the ground truth for performance evaluation is almost always established through comparison to a laboratory reference method (e.g., a YSI analyzer) for blood glucose measurement. The document implies this by focusing on "quantitative measurement of blood glucose levels."

8. The Sample Size for the Training Set

This information is not provided. Blood glucose meters typically do not use a "training set" in the same machine learning sense, but undergo extensive calibration and verification during manufacturing. If an algorithm is involved in the measurement, its development would involve data, but it's not described here.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. As mentioned above, typical blood glucose meter development involves calibration against reference methods.

Summary

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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 03079Phone: (603) 328-6000Fax: (617) 588-0430
Contact:	William H. McGrailExecutive Director, Regulatory & Clinical Affairs
Device Name:	Trade/Proprietary Name: iBGStar Blood Glucose Monitoring SystemCommon Name: Glucose Test System
	Product Name: iBGStar Diabetes Manager ApplicationCommon 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, bloodglucose, 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 processingmodule 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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Image /page/1/Picture/0 description: The image shows the word "AgaMatrix" in a slightly stylized font. The letters are all connected, and there are a few dots above the "t" in "Matrix". The text appears to be printed in black ink on a white background.

Intended Use:

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, Teststrips	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 DiabetesManager app
Indications for Use	Download glucose readings to a datamanagement system to aid in theeffective 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 OperatingSystem 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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Page 2

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.

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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Image /page/5/Picture/0 description: The image shows the logo for AgaMatrix. The logo consists of a circle with a design inside, followed by the word "AgaMatrix" in a stylized font. There is a curved line under the "Aga" and a dotted line above the "Matrix".

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 Control Solutions

The iBGStar Diabetes Manager Application - Home Use

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

Regulation Number and Section

§ 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.