The iglucose™ System collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan® OneTouch® and Home Diagnostics™ True™ monitoring systems to a secure database via wireless cellular technology. Subsequently, blood glucose data can then be reviewed through a web portal as an aid in supporting diabetes management. It is intended to be used in a home or health care facility settings.

The iglucose™ System does not measure, interpret or make decisions on the data that it conveys, nor is it intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

Device Description

The iglucose™ System is designed to assist individuals with diabetes with their record keeping management, by automatically tracking and storing historical blood glucose readings. It has been developed for home or health care facility settings as an aid in supporting diabetes management. iglucose™ is designed to connect to glucose meters and automatically transmit blood glucose reading(s) to a secure database. Users can then utilize the iglucoe™ diabetes management portal (web-based application) to view their blood glucose readings as well as to generate and display reports. At the user's discretion, authorized individuals can also view blood glucose readings and reports.

More specifically, the iglucose™ System is comprised of the following:

· iglucose™ Device
· Secure Database
·iglucose™ Diabetes Management Portal (web-based application)

The iglucose device is approximately the size of a cell phone and has a rechargeable battery. It connects to compatible FDA cleared glucose meters via a data cable and extracts data from a glucose meter. It then wirelessly (via the cellular network) transmits data (blood glucose readings, date and time) from a glucose meter to a secure database. Software used for the database enables the data to be viewable in an organized manner via the iglucose diabetes management portal (web-based application). At the user's discretion, the data can be communicated via email, SMS text message and/or fax.

Data can be displayed in a logbook form. In addition, data can be displayed and trended in reports that are in tabular and graphical formats such as line graphs, pie charts and histograms.

AI/ML Overview

The iglucose™ System is a device designed to collect and transmit stored data from FDA-cleared blood glucose meters to a secure database via wireless cellular technology. This data can then be reviewed through a web portal to aid in diabetes management.

Acceptance Criteria and Reported Device Performance

The provided text details various testing performed on the iglucose™ System, including software, firmware, mechanical, and usability validation. The overarching acceptance criteria for these tests appear to be that "All tests passed" and that the device "performs as expected, and meets all its specification requirements," and "is easy to use and safe for its intended purpose."

Here's a summary of the testing and performance:

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Software Validation	All specified functions perform correctly.	"All tests passed" for examples like Home Page, Registration, Log-in, Administrative Area, device interfacing, and data transmission.
Firmware Validation	All specified functions perform correctly and interoperably.	"All tests passed" for examples like Power and initialization, network communication, glucose meters connection, battery testing, and integration testing.
Mechanical Testing	Durability meets requirements.	"All tests passed" for durability testing on the power cord and data cable.
Usability Study	Effectiveness of user manual, account creation, logging in, connections, viewing readings, and meeting validation success criteria. Device is easy to use and safe.	"Overall the usability test was successful, and demonstrated that the iglucose™ System is easy to use and safe for the purpose for which it is intended."

Study Details:

The provided document describes various validation studies, but it does not detail a study specifically designed to prove acceptance criteria in the manner of a clinical trial for diagnostic accuracy or comparative effectiveness. Instead, the studies focus on functional validation and usability.

Sample Size used for the test set and the data provenance:
- Software Validation: Not specified.
- Firmware Validation: Not specified.
- Mechanical Testing: Not specified.
- Usability Study: Eighteen users with Type 1 or Type 2 diabetes participated.
- Data Provenance: Not explicitly stated for any of the tests, but implied to be internal testing conducted by PositiveID Corporation. The usability study was conducted in May 2011.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The "ground truth" for these tests relates to the functional performance and usability of the device, which would typically be assessed against engineering specifications, user expectations, and safety standards, rather than requiring expert-established clinical ground truth in the traditional sense (e.g., for disease diagnosis).
Adjudication method for the test set:
- This information is not provided. Given the nature of the tests (software, firmware, mechanical, usability), adjudication methods like 2+1 or 3+1 typically used for subjective assessments (e.g., image interpretation) would not apply. Testing likely involved pass/fail criteria based on predefined specifications.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The iglucose™ System is a data collection and transmission device, not an AI-assisted diagnostic tool that would involve "human readers" or AI assistance in clinical interpretation. It "does not measure, interpret or make decisions on the data that it conveys, nor is it intended to provide automated treatment decisions."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The testing described (software, firmware, mechanical) represents testing of the device's standalone functionality. The device transmits data automatically. The usability study also assessed the device's interaction with users, but the core functionality is intended to be automated data transfer.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the various tests mentioned (software, firmware, mechanical) would be the predefined engineering specifications, functional requirements, and safety standards for the device. For the usability study, the ground truth was whether users could successfully perform tasks and perceive the device as easy to use and safe, against predetermined success criteria. There is no mention of clinical ground truth like pathology or outcomes data, as the device does not provide diagnostic information.
The sample size for the training set:
- The document does not mention a training set. The iglucose™ System is not described as utilizing machine learning or AI models that would typically require a training set. Its function is data transmission and presentation.
How the ground truth for the training set was established:
- Since no training set is mentioned or implied for this device, this question is not applicable.

Summary

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510(K) Notification	510 (k) SUMMARY
Section: 5		positive ID
Doc # NA
Confidential

Section 5 510(k) SUMMARY

Date Prepared: June 30, 2011

Company Name and Address:

PositiveID Corporation 1690 South Congress Avenue, Suite 200 Delray Beach, FL 33445 Telephone: 561.805.8015 Contact person: Triana Dorland

Device Name:

Classification Name:

Classification:

Glucose Test System 21 CFR 862.1345 Product code: NBW

Class II

Predicate Devices:

MedApps Remote Patient Monitoring System, K062377, Product Code: NBW
IDEAL LIFE Pod, K080538, Product Code: NBW, JQP

Indications for Use:

The iglucose™ System collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan® OneTouch® and Home Diagnostics™ True™ monitoring systems to a secure database via wireless cellular technology, Subsequently, blood glucose data can then be reviewed through a web portal as an aid in supporting diabetes management. It is intended to be used in a home or health care facility settings.

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510(K) Notification
Section: 5
Doc # NA
Confidential

Image /page/1/Picture/2 description: The image shows the logo for Positive ID. The logo consists of the word "positive" in lowercase letters, followed by a diamond shape containing the letters "ID". The word "positive" is written in a simple, sans-serif font. The diamond shape is outlined in black and has a white interior with the letters "ID" in black. The logo is simple and modern, and it is likely used to represent a company or organization that deals with identity verification or security.

Device Description:

More specifically, the iglucose™ System is comprised of the following:

· iglucose™ Device
· Secure Database
·iglucose™ Diabetes Management Portal (web-based application)

The iglucose™ device is approximately the size of a cell phone and has a rechargeable battery. It connects to compatible FDA cleared glucose meters via a data cable and extracts data from a glucose meter. It then wirelessly (via the cellular network) transmits data (blood glucose readings, date and time) from a glucose meter to a secure database. Software used for the database enables the data to be viewable in an organized manner via the iglucose™ diabetes management portal (web-based application). At the user's discretion, the data can be communicated via email, SMS text message and/or fax.

Data can be displayed in a logbook form. In addition, data can be displayed and trended in reports that are in tabular and graphical formats such as line graphs, pie charts and histograms.

. . .

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Image /page/2/Picture/2 description: The image shows the logo for "positive ID". The word "positive" is written in a sans-serif font, with the "o" replaced by a circle with a dot in the center. To the right of the word is a diamond shape with the letters "ID" inside, also in a sans-serif font.

Summary of Characteristics Compared to Predicate Devices:

The Intended Use and Indications for Use of the predicate devices and the iglucose™ System are virtually the same and all are intended for over the counter use. Intended users are home users and health care providers.

The operation of the subject device is similar to the predicate devices in that the user connects the device to a compatible glucose meters and then initiates the transmission of glucose readings from the glucose meters to a central database. The user or healthcare provider can then access and view glucose readings using a web-based application. The features of the method of operation are described in the table below.

Attribute	MedApps Remote PatientMonitoring System	IDEAL LIFE Pod	Subject Device(iglucose™ System)
	K062377	K080538
Connection toglucose meters	Wirelessly Bluetooth	Wirelessly	Data cable
Compatibleglucose meters	510(k) cleared	Same	Same
Data CollectionSoftwareFunctionality	Transmit data from sensordevice to CentralDatabase	Same	Same
Transmission todatabase	Cellular technology	Telephone Line	Same(as MedApps Predicatedevice)

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、 ! : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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510(K) Notification
Section: 5
Doc # NA
Confidential

Image /page/3/Picture/2 description: The image shows the logo for Positive ID. The logo consists of the word "positive" in a sans-serif font, followed by a diamond shape containing the letters "ID". The diamond shape has a small circle in the upper left corner.

The underlying technology of the iglucose™ System is similar to that of the predicate devices in that they all connect to compatible glucose meters and transmit the glucose readings to a secure central database. They each transmit data using wired or wireless telecommunication. The transmitted data can then be accessed and reviewed by users and healthcare providers. All devices supply historical readings, reports and graphs to the user.

Minor Differences:

There are four minor differences between the iglucose™ and the two predicate devices: 1. Connection to the glucose meters, 2. Power source, 3. Type of telecommunications technology used to communication method with central server and 4. Method of outbound communication of information. These are described in the table below.

Attribute	MedApps RemotePatient MonitoringSystem	IDEAL LIFE Pod	Subject Device(iglucose™Solution)
	K062377	K080538
Connection to glucosemeters	Bluetooth andCellular Technology	Short Range RadioSystem usingBluetooth andwired SmartCable	Data cable
Power source	Wall power plug forhub (120 VAC/50-60)	Wall power plugfor Pod.	Wall power plug(100 to 240 VAC/50-60) andrechargeable batteryin iglucose™
Type ofTelecommunicationsTechnology used;Communicationmethod with centralserver.	Cellular Technology(Cell phone withembedded cellularmodule).	Telephone line(Pod withembedded modem)	CellularTechnology( iglucose™ devicewith embeddedcellular module)
Method of Outboundcommunication ofinformation	Stored in repositorydatabase for accessby the healthcareprovider andInteractive VoiceResponse System	Data is viewed in aweb-basedapplication, sent viaemail. SMS textand fax.	Data is viewed in aweb-basedapplication, sent viaemail, SMS text andfax. No voiceResponse System.

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Summary of Testing:

Software:

Validation was performed as an output requirement from the analysis that led to the software being established as a Moderate Level of Concern. Some examples of testing performed: Home Page, Registration, Log-in Procedure, Administrative Area, device interfacing and data transmission. All tests passed.

Firmware:

Validation was performed as an output requirement from the analysis that led to the device being established as a Moderate Level of Concern. Some examples of testing performed: Power and initialization, network communication, glucose meters connection, battery testing. Also, integration testing was performed in order to test the interoperability and function of the device. All tests passed.

Mechanical:

Durability testing was performed on the power cord and data cable, and all tests passed.

Usability Study:

A usability validation was conducted in May, 2011. Eighteen users with Type 1 or Type 2 diabetes participated in the study. The test goals for the iglucose™ System usability study were to validate: the effectiveness of the user manual, creating accounts, logging in, connections, viewing the readings, and to verify that the validation success criteria were met.

Overall the usability test was successful, and demonstrated that the iglucose™ System is easy to use and safe for the purpose for which it is intended.

Conclusion:

Results of software, firmware and mechanical testing indicate the device performs as expected, and meets all its specification requirements. Usability testing demonstrates the device is easy to use and safe for its intended purpose.

RI . . . .

PositiveID Corporation believes that based on the indications for use, descriptive information, and test results provided in this submission, the iglucose™ System has been shown to be

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510(K) Notification	510 (k) SUMMARY
Section: 5
Doc # NA
Confidential

equivalent in technology, method of operation, functional performance and indications for use to its predicate devices, and is safe for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or abstract human figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

PositiveID Corporation c/o Edward Valdez Quality Systems Manager 1690 S. Congress Avenue, Suite 200 Delray Beach, FL 33445

NOV 1 0 2011

Re: K111932

Trade/Device Name: iglucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW. JOP Dated: October 11, 2011 Received: October 17, 2011

Dear: Mr. Valdez:

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/ResourcesforYou/Industry/default.htm

Sincerely yours,

signature

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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510(K) Notification

positive

Section: 4

Section 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

iglucose™ System

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use X

21 CFR Part 801 Subpart D

21 CFR 801 Subpart C

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD

Division Sign-Off

Office of in Vitro Dlagnostic Device Evaluation and Safety

57000 K 111932

4-1

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.