Rightest Blood Glucose Monitoring System Max is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

Rightest Blood Glucose Monitoring System Max 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Monitoring System Max is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max.

Rightest Blood Glucose Monitoring System Max Plus with Bluetooth function is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

Rightest Blood Glucose Monitoring System Max Plus with Bluetooth function 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Monitoring System Max Plus is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max Plus.

GE Blood Glucose Monitoring System Max is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

GE Blood Glucose Monitoring System Max 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GE Blood Glucose Monitoring System Max is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max.

GE Blood Glucose Monitoring System Max Plus with Bluetooth function is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

GE Blood Glucose Monitoring System Max Plus with Bluetooth function 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GE Blood Glucose Monitoring System Max Plus is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max Plus.

Device Description

For Over-the-Counter Setting:

Rightest Blood Glucose Monitoring System Max and Rightest Blood Glucose Monitoring System Max Plus, consist of the following devices:

Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, lancing device and sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.

Rightest Meter Max and Rightest Meter Max Plus, when used with the Rightest Test Strips Max, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of Rightest Blood Glucose Monitoring System Max and Rightest Blood Glucose Monitoring System Max Plus are verified by the Rightest Control Solution GC700.

GE Blood Glucose Monitoring System Max and GE Blood Glucose Monitoring System Max Plus, consist of the following devices:

GE Meter Max and GE Meter Max Plus, when used with the GE Test Strips Max, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of GE Blood glucose monitoring System Max and GE Blood glucose monitoring System Max Plus are verified by the Rightest Control Solution GC700.

AI/ML Overview

The provided text pertains to a 510(k) premarket notification for a blood glucose monitoring system, not an AI model. Therefore, direct answers to questions regarding acceptance criteria for an AI device, sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for AI are not applicable.

However, I can extract information related to the performance of the blood glucose monitoring system and present it in a format that mirrors the requested table, as well as address the aspects of the study that were performed.

Here's a breakdown of the information available and how it relates to your questions:

Device: Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus. These are glucose test systems (NBW, Class II, 21 CFR 862.1345).

Study Type: This is a premarket notification (510(k)) seeking substantial equivalence to a predicate device (Rightest Blood Glucose Monitoring System GM720, K140210). The studies described are for the performance of a blood glucose meter, not an AI algorithm.

Information applicable to the prompt (adapted for a glucose meter):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format for distinct performance metrics but rather presents various technical specifications and study results to demonstrate substantial equivalence. The provided information focuses on the technical specifications and a lay user performance study.

Acceptance Criteria (Implied/Standard for BGMs)	Reported Device Performance (from "Comparison to Predicate Devices" and "Discussion of Non-Clinical Tests")
Measurement Technology	Dehydrogenase Electrochemical Sensor
Sample Type	Fresh capillary whole blood
Alternative Sample Site	Fingertips, palm, forearm.
Minimum Sample Volume	0.75 microliter
Test Time	5 seconds
Control Solution	3 levels (Level 1, 2, and 4) Rightest Control Solution GC700
Operating Conditions (Temperature)	43 ~111 °F (6 ~ 44°C)
Operating Conditions (Relative Humidity)	10 ~ 90%
Meter Storage Conditions	14~~140 °F (-10~~60℃)
Test Strip Shelf Life (After Opening)	4 months
Hematocrit Range	10 - 70 % (New Device) vs. 20 - 65% (Predicate Device)
Measuring Range	10-600 mg/dL (New Device) vs. 20-600 mg/dL (Predicate Device)
Test Strip Reagent Composition	FAD-Glucose dehydrogenase 12.4 %, Potassium Ferricyanide 49.6 %, Non-reactive Ingredients 38.0 % (New Device) vs. FAD-Glucose dehydrogenase 12.1%, Potassium ferricyanide 48.5%, Non-reactive ingredients 39.4% (Predicate Device)
Interference	Dopamine HCl > 2.3 mg/dL, Gentisic Acid > 3.0 mg/dL, Glutathione reduced > 35 mg/dL, Hemoglobin > 10,000 mg/dL, Uric Acid > 10 mg/dL, Maltose > 1900 mg/dL, Xylose > 9.0 mg/dL (New Device) vs. Ascorbic acid > 3 mg/dL; Glutathione reduced >60 mg/dL; Uric Acid > 12 mg/dL (Predicate Device)
Accuracy (Lay User Performance Study)	"The study result shows substantial equivalence to comparison method." (Specific numerical performance metrics are not provided in this summary, but would typically be based on ISO 15197 accuracy requirements for blood glucose monitoring systems, e.g., ±15% or ±20% agreement with a reference method for certain glucose concentration ranges).
Precision, Linearity, Sample Volume, etc.	Evaluated to establish performance, functionality, and reliability, with results supporting substantial equivalence. (No specific numerical results for these evaluations are provided in the summary)

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

Test Set Sample Size: A "User performance study with 357 participants" was performed.
Data Provenance: The document does not specify the country of origin. It indicates the manufacturer is Bionime Corporation in Taichung City, Taiwan, and the consultant is in San Juan Capistrano, CA, USA. The study type is for a medical device performance validation, which typically involves prospective data collection. It is implied to be prospective as it's a performance study with participants.

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

This section is not applicable as the document describes a study for a blood glucose meter, not an AI interpretation model. The "ground truth" for a blood glucose meter is typically established by comparing its readings to a laboratory reference method (e.g., a central lab analyzer's measurement of glucose in the same blood sample), not by expert consensus on image interpretation.

4. Adjudication Method for the Test Set

This section is not applicable for a blood glucose meter performance study. Adjudication methods are relevant for subjective interpretations, often in imaging or clinical diagnoses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This section is not applicable. An MRMC study is relevant for evaluating the impact of AI systems on human reader performance, typically in diagnostic imaging. This document describes the performance of a blood glucose meter itself.

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

This section is not applicable as the device is a blood glucose meter. Its performance is inherent to the device's measurement capabilities. The "Lay User Performance Study" evaluates the device's accuracy when used by its intended users (individuals with diabetes at home), which includes a human "user-in-the-loop" aspect, but this is about device usability and accuracy, not AI algorithm standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for blood glucose measurements in such studies is typically comparison to a laboratory reference method. The document states that the "study result shows substantial equivalence to comparison method," implying that the device's readings were compared against a highly accurate laboratory standard.

8. The Sample Size for the Training Set

This section is not applicable. Blood glucose meters are not "trained" in the way AI models are. Their performance is based on their electrochemical design and calibration.

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

This section is not applicable as blood glucose meters do not have a "training set" or "ground truth" established for it in the context of machine learning. Their calibration and performance are validated through rigorous lab testing against reference standards.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 17, 2018

Bionime Corporation % Feng-Yu Lee, Principal Consultant Dynamic Biotech Inc. dba IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675

Re: K173638

Trade/Device Name: Rightest Blood Glucose Monitoring System Max Rightest Blood Glucose Monitoring System Max Plus GE Blood Glucose Monitoring System Max GE Blood Glucose Monitoring System Max Plus Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: June 15, 2018 Received: July 20, 2018

Dear Feng-Yu Lee:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K173638

Device Name

Rightest Blood Glucose Monitoring System Max

Indications for Use (Describe)

The Rightest Blood Glucose Monitoring System Max is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K173638

Device Name

Rightest Blood Glucose Monitoring System Max Plus

Indications for Use (Describe)

The Rightest Blood Glucose Monitoring System Max Plus is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max Plus.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NECESSARY

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K173638

Device Name GE Blood Glucose Monitoring System Max

Indications for Use (Describe)

The GE Blood Glucose Monitoring System Max is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K173638

Device Name

GE Blood Glucose Monitoring System Max Plus

Indications for Use (Describe)

The GE Blood Glucose Monitoring System Max Plus is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max Plus.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K173638

Submitter's Identification: 1.
BIONIME CORPORRATION NO 100, Sec. 2, Daqing St., South Dist., 40242 Taichung City, Taiwan Contact Person: Roy Huang Phone Number: 886-4-23692388 FAX Number: 886-4-22617568

c/o IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee Phone Number: 1-949-218-0929 Fax Number: 1-949-218-0928

Date Summary Prepared: August 15th, 2018

1. Name of the Device: Rightest Blood Glucose Monitoring System Max Rightest Blood Glucose Monitoring System Max Plus GE Blood Glucose Monitoring System Max GE Blood Glucose Monitoring System Max Plus
1. Common or Usual Name: Glucose test system

Product Code	Classification	Regulation Section	Panel
NBW; System, Test, BloodGlucose, Over-the-Counter	Class II	21 CFR 862.1345	Clinical Chemistry75

1. Device Description:
  For Over-the-Counter Setting:

Rightest Blood Glucose Monitoring System Max and Rightest Blood Glucose Monitoring System Max Plus, consist of the following devices:

Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, lancing device and sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and

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Lancing Device are manufactured by BIONIME Corporation.

GE Blood Glucose Monitoring System Max and GE Blood Glucose Monitoring System Max Plus, consist of the following devices:

Intended Use: న.

Rightest Blood Glucose Monitoring System Max

The Rightest Blood Glucose Monitoring System Max is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max.

Rightest Blood Glucose Monitoring System Max Plus

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The Rightest Blood Glucose Monitoring System Max Plus is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max Plus.

GE Blood Glucose Monitoring System Max

The GE Blood Glucose Monitoring System Max is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max.

GE Blood Glucose Monitoring System Max Plus

The GE Blood Glucose Monitoring System Max Plus is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max Plus.

6. Predicate Device Information:

Rightest and GE Blood Glucose Monitoring Systems Max and Max Plus are substantially equivalent to:

Rightest Blood Glucose Monitoring System GM720 Device Company: Bionime Corporation 510(K) Number: K140210

7. Comparison to Predicate Devices:

Models	Rightest BGMSMax Plus(New Device)	Rightest BGMS Max(New Device)	Rightest BGMS GM720(Predicate Device)
GE BGMS Max Plus(New Device)	GE BGMS Max(New Device)	K140210

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Bionime Corporation

MeasurementTechnology	Dehydrogenase Electrochemical Sensor
Sample Type	Fresh capillary whole blood
Alternative SampleSite	The fingertips, palm, forearm.
minimum samplevolume	0.75 microliter
Test Time	5 seconds
Control Solution	3 levels (Level 1, 2, and 4)Rightest Control Solution GC700
OperatingConditions	Temperature 43 ~111 °F (6 ~ 44°C), 10 ~ 90% Relative Humidity
Meter StorageConditions	14~~140 °F (-10~~60℃)
Test Strip ShelfLife (AfterOpening)	4 months
Hematocrit Range	10 - 70 %	20 - 65%
Measuring Range	10-600 mg/dL	20-600 mg/dL
Test Strip Reagent	1. FAD-Glucose dehydrogenase 12.4 %2. Potassium Ferricyanide 49.6 %3. Non-reactive Ingredients 38.0 %	1. FAD-Glucosedehydrogenase 12.1%2. Potassium ferricyanide48.5%3. Non-reactiveingredients 39.4%
Interference	Dopamine HCl > 2.3 mg/dLGentisic Acid > 3.0 mg/dLGlutathione reduced > 35 mg/dLHemoglobin > 10,000 mg/dLUric Acid > 10 mg/dLMaltose > 1900 mg/dLXylose > 9.0 mg/dL	Ascorbic acid > 3 mg/dL;Glutathione reduced >60mg/dL; Uric Acid > 12mg/dL
Power Saving	Turn off automatically 2 minutes after last user action / Press the main button for3 seconds.
Coding	Auto coding
Monitor	LCD display

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Bionime Corporation

Models	Rightest BGMSMax Plus(New Device)	Rightest BGMS Max(New Device)	Rightest BGMS GM720(Predicate Device)
	GE BGMS Max Plus(New Device)	GE BGMS Max(New Device)	K140210
Backlight		Yes
Color		black
Memory Capacity	1000 blood glucose test results with date and time	1000 blood glucose test results with date and time	1000 blood glucose test results with date and time
Power Supply	Two CR2032 batteries	One CR2032 battery	Two CR2032 batteries
Wireless module	Yes		No
Battery Life	1000 Tests	1000 Tests	600 Tests
Meter Dimension	50.0 mm x 82.0 mm x 15.5 mm	50.0 mm x 82.0 mm x 15.5 mm	71.5 mm x 39.5 mmx14.0 mm
LCD display area	40.7 mm x 40.2 mm	40.7 mm x 40.2 mm	25.02 mm x 32.7 mm
Meter Weight	59 ± 5g with batteries	59 ± 5g with batteries	50 ± 5 g with batteries

8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:

Verification and validation of test results were evaluated to establish the performance, functionality and reliability of Rightest Blood Glucose Monitoring System Max Plus. The evaluation included precision, linearity, interference, sample volume and hematocrit.

9. Discussion of Clinical Tests Performed:

Layuser Performance Study:

A User performance study with 357 participants was performed to demonstrate that lay users could obtain accurate results using the subject device. The study was performed using capillary whole blood from fingertip, palm and forearm sample sites. The study result shows substantial equivalence to comparison method.

10. Conclusions:

Results of performance evaluation of Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood glucose monitoring System Max and GE Blood glucose monitoring System Max Plus demonstrate that the candidate devises are substantial equivalence to the predicate device, Rightest Blood Glucose Monitoring System GM720.

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.