(125 days)
Not Found
No
The description focuses on data collection, transmission, storage, and display. It explicitly states the system "does not measure, interpret or make decisions on the data that it conveys." There is no mention of AI, ML, or any form of automated analysis or interpretation of the glucose data beyond simple reporting and trending.
No
The device collects and transmits blood glucose data, but explicitly states it "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." This indicates it is a data management tool, not a therapeutic device that administers or provides treatment.
No.
The iglucose™ System is a data collection and transmission system designed to aid in record keeping and diabetes management by automatically tracking and storing historical blood glucose readings. It explicitly states, "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." This indicates it does not perform diagnostic functions.
No
The device description explicitly states the system is comprised of an "iglucose™ Device" which is described as being approximately the size of a cell phone with a rechargeable battery and connects to glucose meters via a data cable. This is a physical hardware component, not solely software.
Based on the provided information, the iglucose™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is a medical device intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples (like blood, urine, etc.) to detect or measure substances.
- iglucose™ System's Function: The iglucose™ System's primary function is to collect, transmit, and display data from existing, FDA-cleared blood glucose meters. It does not perform any analysis or measurement of the blood sample itself. It acts as a data management and communication tool.
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The iglucose™ System does not measure, interpret or make decisions on the data that it conveys..." This directly contradicts the core function of an IVD device, which is to provide information through in vitro examination.
While the iglucose™ System is used in conjunction with blood glucose meters (which are IVD devices), the iglucose™ System itself is a data management and communication system, not an IVD.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, JQP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
It is intended to be used in a home or health care facility 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
| 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:
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.
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.
1
| 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.
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.
- . . .
2
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 Patient
Monitoring System | IDEAL LIFE Pod | Subject Device
(iglucose™ System) |
|----------------------------------------------|------------------------------------------------------------|----------------|------------------------------------------|
| | K062377 | K080538 | |
| Connection to
glucose meters | Wirelessly Bluetooth | Wirelessly | Data cable |
| Compatible
glucose meters | 510(k) cleared | Same | Same |
| Data Collection
Software
Functionality | Transmit data from sensor
device to Central
Database | Same | Same |
| Transmission to
database | Cellular technology | Telephone Line | Same
(as MedApps Predicate
device) |
Image /page/2/Picture/9 description: The image is a blank white square. There are no objects or figures in the image. The image does not contain any text. The image is completely white.
、 ! : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
| 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 Remote
Patient Monitoring
System | IDEAL LIFE Pod | Subject Device
(iglucose™
Solution) |
|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | K062377 | K080538 | |
| Connection to glucose
meters | Bluetooth and
Cellular Technology | Short Range Radio
System using
Bluetooth and
wired SmartCable | Data cable |
| Power source | Wall power plug for
hub (120 VAC/50-
60) | Wall power plug
for Pod. | Wall power plug
(100 to 240 VAC/
50-60) and
rechargeable battery
in iglucose™ |
| Type of
Telecommunications
Technology used;
Communication
method with central
server. | Cellular Technology
(Cell phone with
embedded cellular
module). | Telephone line
(Pod with
embedded modem) | Cellular
Technology
( iglucose™ device
with embedded
cellular module) |
| Method of Outbound
communication of
information | Stored in repository
database for access
by the healthcare
provider and
Interactive Voice
Response System | Data is viewed in a
web-based
application, sent via
email. SMS text
and fax. | Data is viewed in a
web-based
application, sent via
email, SMS text and
fax. No voice
Response System. |
4
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
5
| 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.
6
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).
7
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
8
510(K) Notification
positive
Section: 4
Section 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
iglucose™ System
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.
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.
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
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