(149 days)
Telcare Blood Glucose Monitoring System: The Telcare Blood Glucose Monitoring system is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended for lay use by persons with diabetes to aid in diabetes management. It is indicated for use at home (over the counter [OTC]) and should be used only by a single patient and should not be shared. Testing is done outside the body (in vitro diagnostic use). The Telcare Blood Glucose Monitoring System consists of the Telcare Blood Glucose Meter, Telcare Blood Glucose Test Strips, and Telcare Glucose Control Solutions. The Telcare Blood Glucose Monitoring system is not indicated for the diagnosis or screening of diabetes or for neonatal use. Palm and forearm testing should be done only during steady-state times when glucose is not changing rapidly. The Telcare Blood Glucose Meter uses cellular data transmission to send test results to Telcare's remote database, Telserve, and to receive messages from Telserve. The Telcare Blood Glucose Monitoring System is not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare judgment.
Telcare Blood Glucose Test Strips: The Telcare Blood Glucose Test Strips are to be used with the Telcare Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, palm, or forearm. These test strips are intended for lay use by persons with diabetes and should only be used by a single patient. They are not indicated for the diagnosis or screening of diabetes or for neonatal use. Palm and forearm testing should be done only during steady-state times when glucose is not changing rapidly.
Telcare Glucose Control Solutions: The purpose of the control solution test is to validate the performance of the Telcare Blood Glucose Monitoring System by using a test solution with a known amount of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.
Telserve Data Management System - Home Use: The Telserve Data Management System - Home Use (Telserve - Home) is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management. Telserve collects data from blood glucose meters such as the Telcare BGM. Telserve - Home is not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare judgment.
Telserve Data Management System - Professional Use: The Telserve Data Management System - Professional Use (Telserve - Pro) is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management. Telserve collects data from blood glucose meters such as the Telcare BGM.
The Telcare Blood Glucose Monitoring System consists of the Telcare Blood Glucose Meter (BGM), Telcare Blood Glucose Test Strips, and Telcare Glucose Control Solutions. The Telcare BGM, when used with the Telcare Test Strips, quantitatively measures glucose in capillary whole blood. The Telcare Control Solutions verify the performance of the Telcare Test Strips. An embedded cellular module within the Telcare BGM enables wireless communication between the meter and Telcare's remote database, called the Telserve Data Management System (Telserve).
The Telserve Data Management System serves as an accessory to blood glucose meters to assist in the review and evaluation of blood glucose test results and related information to aid in diabetes management. The software system consists of two different levels of functionality: 1) Telserve Data Management System - Home Use and 2) Telserve Data Management System - Professional Use.
The Telcare Blood Glucose Monitoring System consists of a Blood Glucose Meter (BGM), Test Strips, Control Solutions, and the Telserve Data Management System (Home Use and Professional Use). The acceptance criteria and supporting studies are described below:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly state numerical acceptance criteria for the quantitative performance of the Telcare Blood Glucose Monitoring System (e.g., accuracy percentages for glucose levels). Instead, it lists various non-clinical and clinical tests performed, with a general statement that "All testing demonstrated safety and effectiveness of the Telcare Blood Glucose Monitoring system and substantial equivalence to the predicate." and "The results show Telcare BGM System and Telserve showed substantial equivalence to the predicate devices."
Therefore, for the purpose of this response, the "acceptance criteria" are inferred to be the successful completion of the listed tests and the demonstration of substantial equivalence to predicate devices. The "reported device performance" is the claim of achieved substantial equivalence.
| Acceptance Criteria (Inferred from testing performed) | Reported Device Performance (Claimed in the 510(k) Summary) |
|---|---|
| Non-Clinical (Telcare BGM System) | |
| Minimum Sample Volume met | Demonstrated safety and effectiveness; substantial equivalence to predicate. |
| Linearity met | Demonstrated safety and effectiveness; substantial equivalence to predicate. |
| Detection Limit met | Demonstrated safety and effectiveness; substantial equivalence to predicate. |
| Precision met | Demonstrated safety and effectiveness; substantial equivalence to predicate. |
| Hematocrit effects within acceptable limits | Demonstrated safety and effectiveness; substantial equivalence to predicate. |
| Altitude effects within acceptable limits | Demonstrated safety and effectiveness; substantial equivalence to predicate. |
| Humidity/Temperature effects within acceptable limits | Demonstrated safety and effectiveness; substantial equivalence to predicate. |
| Interfering Substances effects within acceptable limits | Demonstrated safety and effectiveness; substantial equivalence to predicate. |
| Control Solution Qualification met | Demonstrated safety and effectiveness; substantial equivalence to predicate. |
| EMC, Electrical Safety, and FCC standards met | Demonstrated safety and effectiveness; substantial equivalence to predicate. |
| Software verification and validation completed (Telcare BGM) | Demonstrated safety and effectiveness; substantial equivalence to predicate. |
| Non-Clinical (Telserve Data Management System) | |
| Software verification and validation completed (Telserve) | Demonstrated safety and effectiveness; substantial equivalence to predicate. |
| Clinical (Telcare BGM System) | |
| Ease of use of Telcare BGM (User Performance Study) | Demonstrated substantial equivalence to predicate devices. |
| Ease of understanding Telcare BGM user manual (User Performance Study) | Demonstrated substantial equivalence to predicate devices. |
| Accuracy and user performance with fresh fingertip, palm, and forearm testing | Demonstrated substantial equivalence to predicate devices. |
| User control solution testing success | Demonstrated substantial equivalence to predicate devices. |
| Ease of use of Telcare BGM Test Strip Insertion Process (User Performance Study) | Demonstrated substantial equivalence to predicate devices. |
| Ease of understanding Telcare BGM Test Strip Insertion instructions (User Performance Study) | Demonstrated substantial equivalence to predicate devices. |
| Clinical (Telserve Data Management System) | |
| Ease of use of Telserve-Home and user manual (User Performance Study) | Demonstrated substantial equivalence to predicate devices. |
| Ease of obtaining login credentials for Telserve-Home (User Performance Study) | Demonstrated substantial equivalence to predicate devices. |
| Ease of use of Telserve-Pro, obtaining login credentials, and user manual (User Performance Study) | Demonstrated substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided 510(k) summary does not specify the exact sample sizes for the test sets in the clinical studies. It only mentions that "A User Performance Study was conducted..." and "An Accuracy and User Performance Study was conducted..." without detailing the number of participants or samples.
The data provenance (e.g., country of origin of the data, retrospective or prospective) is also not explicitly stated. However, given that this is a 510(k) submission to the FDA, it is highly likely that the studies were conducted in the United States, and typically, such performance studies for medical devices are prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The 510(k) summary does not provide information on the number or qualifications of experts used to establish ground truth for the clinical studies, particularly for the "Accuracy and User Performance Study." For blood glucose monitoring systems, ground truth for accuracy is typically established by laboratory reference methods (e.g., YSI analyzer) performed by trained laboratory personnel, rather than "experts" in the sense of clinicians providing a diagnosis.
4. Adjudication Method for the Test Set:
The 510(k) summary does not describe any adjudication method for the test set in the clinical studies. This is generally not applicable to studies for blood glucose meters where the output is a quantitative measurement compared against a reference method.
5. 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:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or interpretation tool where human readers assess cases. The "Telserve" component is a data management system, not an AI for interpretation or diagnosis, and the studies described are user performance and accuracy for the meter itself.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
A "standalone" study in the sense of an algorithm-only performance for a diagnostic AI was not performed because this device is a blood glucose monitoring system, which provides direct measurements. The "Telserve Data Management System" is software for data handling, not an analytical algorithm for standalone diagnostic performance beyond displaying the meter's results. The accuracy studies for the BGM are inherently standalone for the device's measurement capability.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
For the "Accuracy and User Performance Study" conducted for the Telcare BGM, the ground truth for glucose measurements would typically be established using a laboratory reference method (e.g., a YSI glucose analyzer) on venous blood samples, which is considered the gold standard for clinical chemistry. The 510(k) summary does not explicitly state the reference method used but this is standard practice for glucose meter accuracy studies.
8. The Sample Size for the Training Set:
The provided 510(k) summary does not mention any "training set" or "training data" as would be relevant for machine learning or AI algorithm development. The device described, particularly the Blood Glucose Monitoring System, is a traditional electrochemical biosensor device. The Telserve Data Management System is software for data management, not an AI system that undergoes a separate training phase.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no mention of a "training set" in the context of AI or machine learning for this device in the provided summary. The device's components (meter, strips, control solutions) are tested for their inherent performance and accuracy against established analytical methods and user performance metrics, not through a machine learning training paradigm.
{0}------------------------------------------------
510(k) Summary
| Submitter: | Jonathan Javitt, M.D., M.P.H., Chief Executive OfficerTelcare, Inc.2 Bethesda Metro Center, Suite 1350Bethesda, MD, 20814 |
|---|---|
| Contact Person: | Jonathan Javitt, M.D., M.P.H., Chief Executive OfficerTelcare, Inc.2 Bethesda Metro Center, Suite 1350Bethesda, MD, 20814Telephone: (240) 396-6003, Fax: 877-777-4710Email: JJavitt@telcare.com |
| Date Prepared: | July 27, 2011 |
| Trade Names: | Telcare Blood Glucose Monitoring System, Telserve Data ManagementSystem, Telcare Blood Glucose Test Strips, Telcare Glucose Control Solutions |
| ClassificationNames: | Glucose test system, 21 CFR 862.1345, Class IIQuality control material (assayed and unassayed), 21 CFR 862.1600, Class ICalculator/data processing module for clinical use, 21 CFR 862.2100, Class IExempt (non exempt is associated with blood glucose monitoring system) |
| Product Codes: | NBW, CGA, JJX, JQP |
| PredicateDevices: | AutoSure Voice II Blood Glucose Monitoring System (BGM) - K102037,MCT-Diabetes (Data Management Software) - K073699, Gluco Track BloodGlucose Monitoring System (control solutions) – K062799 |
| DeviceDescription: | The Telcare Blood Glucose Monitoring System consists of the Telcare BloodGlucose Meter (BGM), Telcare Blood Glucose Test Strips, and TelcareGlucose Control Solutions. The Telcare BGM, when used with the TelcareTest Strips, quantitatively measures glucose in capillary whole blood. TheTelcare Control Solutions verify the performance of the Telcare Test Strips.An embedded cellular module within the Telcare BGM enables wirelesscommunication between the meter and Telcare's remote database, called theTelserve Data Management System (Telserve).The Telserve Data Management System serves as an accessory to bloodglucose meters to assist in the review and evaluation of blood glucose testresults and related information to aid in diabetes management. The softwaresystem consists of two different levels of functionality: 1) Telserve DataManagement System - Home Use and 2) Telserve Data Management System - |
| Intended Use: | Telcare Blood Glucose Monitoring System |
| The Telcare Blood Glucose Monitoring system is intended for the quantitative | |
| measurement of glucose in fresh capillary whole blood samples drawn from | |
| the fingertips, forearm, or palm. It is intended for lay use by persons with | |
| diabetes to aid in diabetes management. It is indicated for use at home (over | |
| the counter [OTC]) and should be used only by a single patient and should not | |
| be shared. Testing is done outside the body (in vitro diagnostic use). The | |
| Telcare Blood Glucose Monitoring System consists of the Telcare Blood | |
| Glucose Meter, Telcare Blood Glucose Test Strips, and Telcare Glucose | |
| Control Solutions. The Telcare Blood Glucose Monitoring system is not | |
| indicated for the diagnosis or screening of diabetes or for neonatal use. Palm | |
| and forearm testing should be done only during steady-state times when | |
| glucose is not changing rapidly. The Telcare Blood Glucose Meter uses | |
| cellular data transmission to send test results to Telcare's remote database, | |
| Telserve, and to receive messages from Telserve. The Telcare Blood Glucose | |
| Monitoring System is not intended to provide automated treatment guidance or | |
| decisions, nor is it to be used as a substitute for professional healthcare | |
| judgment. | |
| Telcare Blood Glucose Test Strips | |
| The Telcare Blood Glucose Test Strips are to be used with the Telcare Blood | |
| Glucose Meter for the quantitative measurement of glucose in fresh capillary | |
| whole blood samples drawn from the fingertips, palm, or forearm. These test | |
| strips are intended for lay use by persons with diabetes and should only be | |
| used by a single patient. They are not indicated for the diagnosis or screening | |
| of diabetes or for neonatal use. Palm and forearm testing should be done only | |
| during steady-state times when glucose is not changing rapidly. | |
| Telcare Glucose Control Solutions | |
| The purpose of the control solution test is to validate the performance of the | |
| Telcare Blood Glucose Monitoring System by using a test solution with a | |
| known amount of glucose. A control test that falls within the acceptable range | |
| indicates the user's technique is appropriate and the test strip and meter are | |
| functioning properly. |
1
JUL 2 8 2011
{1}------------------------------------------------
510(k) Summary (Cont'd)
{2}------------------------------------------------
510(k) Summary (Cont'd)
| Intended Use(Cont'd) | The Telserve Data Management System - Home Use (Telserve - Home) is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management. Telserve collects data from blood glucose meters such as the Telcare BGM. Telserve - Home is not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare judgment.The Telserve Data Management System - Professional Use (Telserve - Pro) is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management. Telserve collects data from blood glucose meters such as the Telcare BGM. |
|---|---|
| TechnologicalCharacteristics | The Telcare Blood Glucose Monitoring System consists of a glucose meter that can wirelessly transmit data to a remote database using standard cellular technology embedded within the glucose meter. The meter uses biosensor test strips. Telserve Data Management System consists entirely of software run on a central server. |
| Non-ClinicalTesting | Telcare BGM: Minimum Sample Volume, Linearity, Detection Limit, Precision, Hematocrit, Altitude, Humidity/Temperature, and Interfering Substances testing were done. Control Solution Qualification was conducted. EMC, Electrical Safety and FCC testing were conducted. Software verification and validation were done. All testing demonstrated safety and effectiveness of the Telcare Blood Glucose Monitoring system and substantial equivalence to the predicate.Telserve Data Management System: Software verification and validation demonstrated safety and effectiveness of the Telserve remote database and substantial equivalence to the predicate. |
·
:
{3}------------------------------------------------
510(k) Summary (Cont'd)
: ****
| Clinical | Telcare Blood Glucose Monitoring (BGM) System: |
|---|---|
| Testing: | A User Performance Study was conducted to evaluate the ease of use of theTelcare BGM and ease of understanding of the Telcare BGM user manual. |
| An Accuracy and User Performance Study was conducted withprofessional and self-testing with fresh fingertip, palm and forearm testing.User control solution testing was conducted. | |
| A User Performance Study was conducted to evaluate the ease of use of theTelcare BGM Test Strip Insertion Process and ease of understanding of theTelcare BGM Test Strip Insertion instructions in the user manual. | |
| Telserve Data Management System (Telserve): | |
| A User Performance Study was conducted to evaluate the ease of use ofTelserve-Home and ease of understanding of the Telserve - Home usermanual. | |
| A User Performance Study was conducted to evaluate the ease of useobtaining login credentials to Telserve and ease of understanding of theTelserve - Home user manual. | |
| A User Performance Study was conducted to evaluate the ease of use ofTelserve-Pro, the ease of use of obtaining login credentials, and ease ofunderstanding of the Telserve - Pro user manual. | |
| The results show Telcare BGM System and Telserve showed substantialequivalence to the predicate devices. | |
| Conclusion: | The Telcare Blood Glucose Monitoring System and its accessory TelserveData Management System are substantially equivalent to their predicatedevices. |
{4}------------------------------------------------
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, clutching a staff with a snake wrapped around it, which is a symbol of medicine and healing.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
JUL 2 8 2011
Telcare, Incorporated c/o Dr. Jonathan C. Javitt Chief Executive Officer 3 Bethesda Metro Center Suite 430 Bethesda, MD 20814
Re: K110571
·
Trade Name: Telcare Blood Glucose Monitoring System, Telserve Data Management System - Home Use, Telserve Data Management System - Professional Use
Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, JJX, JQP Dated: July 8, 2011 Received: July 11, 2011
Dear Dr. Javitt:
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).
{5}------------------------------------------------
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
いなき
Enclosure
{6}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): K110571
Telcare Blood Glucose Monitoring System Device Name: Telserve Data Management System - Home Use Telserve Data Management System - Professional Use
Indications for Use:
Telcare Blood Glucose Monitoring System
The Telcare Blood Glucose Monitoring system is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended for lay use by persons with diabetes to aid in diabetes management. It is indicated for use at home (over the counter [OTC]) and should be used only by a single patient and should not be shared. Testing is done outside the body (in vitro diagnostic use). The Telcare Blood Glucose Monitoring System consists of the Telcare Blood Glucose Meter, Telcare Blood Glucose Test Strips, and Telcare Glucose Control Solutions. The Telcare Blood Glucose Monitoring system is not indicated for the diagnosis or screening of diabetes or for neonatal use. Palm and forearm testing should be done only during steady-state times when glucose is not changing rapidly. The Telcare Blood Glucose Meter uses cellular data transmission to send test results to Telcare's remote database.Telserve, and to receive messages from Telserve. The Telcare Blood Glucose Monitoring System is not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare judgment.
Telcare Blood Glucose Test Strips
The Telcare Blood Glucose Test Strips are to be used with the Telcare Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, palm, or forearm. These test strips are intended for lay use by persons with diabetes and should only be used by a single patient. They are not indicated for the diagnosis or screening of diabetes or for neonatal use. Palm and forearm testing should be done only during steady-state times when glucose is not changing rapidly.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 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
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110571
{7}------------------------------------------------
510(k) Number (if known): K110571
Telcare Glucose Control Solutions
The purpose of the control solution is to validate the performance of the Telcare Blood Glucose Monitoring System by using a test solution with a known amount of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.
Telserve Data Management System - Home Use
The Telserve Data Management System - Home Use (Telserve - Home) is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management. Telserve collects data from blood glucose meters such as the Telcare BGM. Telserve - Home is not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare judgment.
Telserve Data Management System - Professional Use
The Telserve Data Management System - Professional Use (Telserve - Pro) is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management. Telserve collects data from blood glucose meters such as the Telcare BGM.
Prescription Use ___ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 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
acting
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) A110531/
§ 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.