The Glooko device system for Glooko Logbook+ Application is a data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Logbook+ Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their iPhone operating system platform.

The Glooko device system for Glooko Loabook+ Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

Device Description

The Glooko device system for Glooko Logbook+ Application is used to aid individuals with diabetes in the download, review, analysis, evaluation, and communication of their blood glucose readings. The system allows users to download readings from compatible, FDA-cleared, commercial blood glucose meters to their iPhone Operating System (iOS) devices, and then share this information with healthcare professionals. It is intended for use both in home and professional settings to support an effective diabetes management program. The data may be displayed on supported devices to provide an online view of all collected data and notes from the Glooko Logbook+ Application. The system does not provide treatment decisions and cannot be used as a substitute for professional healthcare advice.

The Glooko device system for Logbook+ Application consists of the following components:

The Glooko MeterSync Cable
The Glooko IR Adapter
The Glooko Logbook+ Application

AI/ML Overview

The document describes the Glooko device system for Glooko Logbook+ Application, which is a data management software for individuals with diabetes to download, review, analyze, evaluate, and communicate their blood glucose readings. The submission is a Special 510(k) and demonstrates substantial equivalence to a previously cleared predicate device (K122142).

Here's an analysis of the provided text in relation to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., accuracy percentages, error rates) alongside reported device performance for a clinical study. Instead, it relies on verification and validation testing to confirm performance according to specifications and intended use. The core acceptance criteria appear to be functional compliance with design specifications and equivalence to the predicate device.

Acceptance Criteria (Inferred)	Reported Device Performance
Device performs according to stated intended use and specifications (functional, software, and data integrity).	"All test results fell within the pre-determined specification parameters." The device underwent "Software Verification and Validation" including "Data Integrity Verification, Software Design/features Verification, and error handling testing." These studies "demonstrated that the Glooko Device System for Glooko Logbook+ Application performed according to the specifications and the intended use."
Substantial equivalence to the predicate device (K122142) in intended use and function.	"The Glooko Device System for Glooko Logbook+ Application is substantially equivalent to the predicate device with regards to its intended use and function." Both use the same technology to download data and analyze blood glucose meter data producing basic statistics and graphs.
Data security (for new features like transmitting data across multiple devices/web browsers).	"To ensure data security, a login credential feature was added. To protect sensitive health information from unauthorized access during transmission, all data on the Glooko network is protected using the Secure Sockets Layer (SSL) protocol. In addition, Glooko forces the https:// standard for all mobile and web communication features... All data in the Glooko system is encrypted end-to-end using 256-bit Advance Encryption Standard (AES) encryption for message data both in transmission and storage."
No new questions of safety and effectiveness are raised by new features (e.g., new view options, goal setting).	"These additional features did not raise any new questions about safety and effectiveness." (referring to multiple view options). "This feature (goal setting) neither affects the blood glucose data nor raises any new questions of safety and effectiveness."

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

The document does not specify a distinct "test set" sample size in terms of patient data or clinical cases. The testing described is primarily functional and software verification/validation.

Sample Size: Not explicitly stated for patient data. The testing involved various compatible meters and iOS devices.
Data Provenance: Not applicable in the context of clinical trial data. The device functions by downloading data from FDA-cleared blood glucose meters, which implies the data itself originates from those meters. The device itself is a data management system, not a diagnostic one generating its own primary data.

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

This information is not provided in the document. The device is a data management system, and its correctness is assessed through software verification and validation against its own design specifications and the data downloaded from compatible blood glucose meters, rather than against an expert-established "ground truth" for clinical outcomes or diagnoses.

4. Adjudication Method for the Test Set

This information is not provided and is likely not relevant for this type of software verification and validation. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient data by multiple experts. The testing here focuses on technical functionality and data integrity.

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

This information is not provided and is not applicable. The Glooko Device System, as described, is a data management and display tool, not an AI-assisted diagnostic or interpretation system that would involve human "readers" interpreting output. Its purpose is to present blood glucose data for review by individuals and healthcare professionals.

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

The device itself is a "standalone" software system in the sense that its algorithms perform data download, storage, calculation of statistics, and graphing without human intervention in those specific computational steps. However, it is explicitly stated that the device "does not provide treatment decisions and cannot be used as a substitute for professional healthcare advice." Therefore, it's a standalone component of a larger diabetes management program where humans (patients and healthcare professionals) still make all interpretative and treatment decisions. The document refers to "Software Verification and Validation" which implies standalone algorithm testing.

7. The Type of Ground Truth Used

The "ground truth" for this device primarily relies on:

Design Specifications: The software's output (e.g., downloaded glucose readings, calculated statistics, displayed graphs) is validated against its pre-determined design specifications.
Data Integrity Verification: Ensuring that the data downloaded from compatible, FDA-cleared blood glucose meters is transferred, stored, and displayed accurately, meaning the "ground truth" for the data points themselves comes from the original blood glucose meters.
Predicate Device Functionality: The performance of the new features and overall functionality is compared for substantial equivalence to the previously cleared predicate device.

It does not use expert consensus, pathology, or outcomes data as its primary ground truth, as it is not a diagnostic device.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This is a software verification and validation report for a data management system, not a machine learning model that typically requires a large training set.

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

Since there is no mention of a training set or machine learning model, the concept of establishing ground truth for a training set is not applicable to this submission as described.

Summary

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K130886

n for Glooko Logbook+ Application pecial 510(k) Submission 10(k) Summary Page 1 of 7

SECTION 7

APR 2 5 2013

510(k) Summary (21 CFR § 807.92(c))

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

Submitter:	Glooko, Inc.170A University AvenuePalo Alto, CA 94301
Contact:	Shilpa MydurRegulatory Affairs ManagerPhone: 650.720.5310Email: shilpa@glooko.com
Date Summary Prepared:	22 April 2013
Device Trade Name:	Glooko Device System for Glooko Logbook+Application
Common Name:	Blood Glucose Meter and Data ManagementSystem
Classification Name:	Glucose test system(21 CFR §862.1345)Calculator/data processing module for clinical use(21 CFR §862.2100)
Product Code:	NBW and JQP
Equivalent Device:	Glooko Device System for Glooko LogbookApplication and Glooko Logbook Charts (K122142)

Device Description:

Overview

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The Glooko device system for Logbook+ Application consists of the following components

1. The Glooko MeterSync Cable
1. The Glooko IR Adapter
1. The Glooko Logbook+ Application

Glooko MeterSync Cable

The Glooko MeterSync Cable downloads data from compatible, FDA-cleared, commercial blood glucose meters into an iOS device by connecting the two components. One end of the Glooko MeterSync Cable plugs directly into the 30-pin connector slot of the iOS device. The 3.5mm end of the Glooko MeterSync Cable plugs directly into most compatible meters to allow for the transfer of data. Some meters require an additional 3.5mm to 2.5mm adapter to allow for this connectivity, while other meters transfer data through infrared, and thus require the use of the Glooko IR Adapter.

The Glooko MeterSync Cable is designed to attach to a variety of compatible, FDAcleared, commercial blood glucose meters. The users simply connect the supported meters to their iOS device and transfer the blood glucose meter data into the Glooko Logbook+ Application.

Glooko IR Adapter

The Glooko IR Adapter is designed to transmit data via infrared from a variety of compatible, FDA-cleared, commercial blood glucose meters into the Glooko Logbook+ Application. The user connects the Glooko IR Adapter to the 3.5mm adapter end of the Glooko MeterSync Cable to transmit data from the compatible meters.

The Glooko Logbook+ Application:

The Glooko Logbook+ Application is one component of the Glooko data monitoring system used to aid individuals with diabetes in the review, analysis, evaluation, and communication of their blood glucose readings.

The Glooko Logbook+ Application collects and stores historical blood glucose data that has been downloaded from blood glucose meters. The Glooko Logbook+ Application also lets the user sync and view data from any supported compatible device when using the appropriate login information.

The Glooko Logbook+ Application keeps an organized log of the users blood glucose readings and allows for the addition of user-generated notes and meal tags. The Glooko Logbook+ Application also shows graphs, provides statistics, and allows for the sharing and viewing of blood glucose data across multiple supported devices. The user can also create goals as they aim to manage their blood glucose readings.

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Glooko Device system for Glooko Logbook+ Application Special 510(k) Submission-K130886 510(k) Summarv Page 3 of 7

The Glooko Logbook+ Application is compatible with the following FDA-cleared blood qlucose meters:

Abbott: FreeStyle Freedom Lite®, FreeStyle Lite® .
ARKRAY: GLUCOCARD® 01, GLUCOCARD® Vital™ .
Bayer: Bayer's BREEZE®2, Bayer's CONTOUR®, Bayer's CONTOUR® NEXT . EZ.
. iSens: CareSens N and CareSens N POP
LifeScan: OneTouch® Ultra®2, OneTouch® UltraLink®, OneTouch® UltraMini® .
ReliOn: ReliOn® Confirm, ReliOn® Prime .
Roche: ACCU-CHEK® Aviva, ACCU-CHEK® Compact Plus, ACCU-CHEK® Nano .

The Glooko Logbook+ Application can be operated on the following iOS devices, each supporting iOS 5.0 and higher:

iPod touch®: 3rd and 4th generations .
iPhone®: 3GS, 4, 4S, 5 .
iPad®: 1st, 2nd 3rd and 4th generations, iPad mini, the Glooko Logbook+ . Application is not native to the iPad but it can be accessed in 2x mode

The Glooko Logbook+ Application is compatible with the following web browsers:

Internet Explorer- v8.0 and above .
. Firefox- v3.0 and above
Chrome- v14.0 and above .
Safari-v4.0 and above .
iOS (Safari)- v3.0 and above .

Software Requirements:

The Glooko Logbook+ Application performs the following functions:

. Sync with compatible meters
Allow users to annotate readings with notes ●
Provide multiple view options for the data .
Graph the glucose readings .
Provide statistics .
. Allow for goals to be set
Share the collected data .
. Transmit and view readings, graphs, statistics and notes across supported multiple devices and web browsers when using consistent authentication credentials (username and password)

Technological Characteristics:

The table below provides the comparison of technological characteristics between the subject and predicate device

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Glooko Device system for Glooko Logbook+ Application
Special 510(k) Submission-K130886 510(k) Summary
Page 4 of 7

Table 1: Summary of Technological Characteristics

Product	Glooko device system forLogbook Application andGlooko Logbook Charts(K122142)	Glooko Device System forGlooko Logbook+ Application(K130886)
Software	Glooko Logbook Application	Glooko Logbook+ Application
Hardware	MeterSync CableIR Adapter	Same
Blood glucose metercompatibility	Abbott: FreeStyle FreedomLite®, FreeStyle Lite®Bayer: Bayer's BREEZE®2,Bayer's CONTOUR®, Bayer'sCONTOUR® NEXT EZ, Bayer'sCONTOUR® XTGLUCOCARD: GLUCOCARD®01, GLUCOCARD® VitalTMLifeScan: OneTouch® Ultra®2,OneTouch® UltraLink®,OneTouch® UltraMini®ReliOn: ReliOn® Confirm,ReliOn® PrimeRoche: ACCU-CHEK® Aviva,ACCU-CHEK® Aviva Nano,ACCU-CHEK® Compact Plus,ACCU-CHEK® Nano	Abbott: FreeStyle Freedom Lite®,FreeStyle Lite®Bayer: Bayer's BREEZE®2,Bayer's CONTOUR®, Bayer'sCONTOUR® NEXT EZ, Bayer'sCONTOUR® XTGLUCOCARD: GLUCOCARD® 01,GLUCOCARD® VitalTMLifeScan: OneTouch® Ultra®2,OneTouch® UltraLink®,OneTouch® UltraMini®ReliOn: ReliOn® Confirm, ReliOn®PrimeRoche: ACCU-CHEK® Aviva,ACCU-CHEK® Aviva Nano, ACCU-CHEK® Compact Plus, ACCU-CHEK® NanoCareSens N and CareSens N POP
Operating System	iOS 4.3 and higher	iOS 5.0 and higher
Hardware	• iPod touch®: 3rd and 4thgenerations• iPhone®: 3GS, 4, 4S• iPad®: iPad 1, iPad 2, andiPad (3rd generation) –(Accessed in 2x mode)	• iPod touch®: 3rd and 4thgenerations• iPhone®: 3GS, 4, 4S• iPad®: iPad 1, iPad 2, and iPad(3rd generation) –(Accessed in 2xmode)• iPod touch 5th generation, iPhone5, iPad mini, and iPad 4thgeneration (These devices requireApple's off-the-shelf Lightning to30-pin adapter for connection.)
Syncs with compatiblemeters	Yes	Yes
Allow users toannotate readings withnotes	Yes	Yes
Product	Glooko device system forLogbook Application andGlooko Logbook Charts(K122142)	Glooko Device System forGlooko Logbook+ Application(K130886)
Provide multiple viewoptions for the data	Yes	Yes.Additionally, same data ispresented in different ways like ListView, Day View, Month View AndLogbook View. Readings in Listand Logbook views are color-codedto indicate if they are high, low orwithin range. These features wereadded for user convenience. Theseadditional features did not raise anynew questions about safety andeffectiveness.
Share the collecteddata	Yes	Yes
Provide statistics	Yes via supported webdownload of Glooko LogbookCharts from PC	Yes, across multiple devices andsupported web browsers.
Graph the glucosereadings	Yes via supported webdownload of Glooko LogbookCharts from PC	Yes, across multiple devices andsupported web browsers.
Allow goals to be set	No	YesGoals can be set to help motivatehealthy lifestyle choices. The fivegoals that can be added are limitedto:> Test blood glucose regularly> Sync meter more often> Keep readings within range> Add meal tags to readings> Exercise more often.This feature neither affects theblood glucose data nor raises anynew questions of safety andeffectiveness.
Product	Glooko device system forLogbook Application andGlooko Logbook Charts(K122142)	Glooko Device System forGlooko Logbook+ Application(K130886)
Transmit and viewdata across supportedmultiple devices andweb browsers usingconsistentauthenticationcredentials(username/password)	No	Yes, to ensure data security, alogin credential feature was added.To protect sensitive healthinformation from unauthorizedaccess during transmission, alldata on the Glooko network isprotected using the Secure SocketsLayer (SSL) protocol. In addition,Glooko forces the https:// standardfor all mobile and webcommunication features, protectingfrom unauthorized access overwireless and wired networks. Alldata in the Glooko system isencrypted end-to-end using 256-bitAdvance Encryption Standard(AES) encryption for message databoth in transmission and storage.

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Glooko Device system for Glooko Logbook+ Application
Special 510(k) Submission-K130886
510(k) Summary
Page 5 of 7

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Glooko Device system for Glooko Logbook+ Application Special 510(k) Submission-K130886 510(k) Summarv Page 6 of 7

Intended Use:

The Glooko device system for Glooko Logbook+ application is data management software intended for use in home and professional settings to aid individuals with diabetes and their healthcare professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Logbook+ application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their iPhone operating system platform.

The Glooko device system for Glooko Logbook+ application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice. .

Summary of Testing:

The Glooko Logbook+ Application underwent verification and validation testing. A brief summary of the tests performed is described below. These studies demonstrated that the Glooko Device System for Glooko Logbook+ Application performed according to the specifications and the intended use.

Software Verification and Validation

A The Glooko Device system (Glooko Logbook+ Application, Cable and Adapter) was validated pursuant to the moderate level of concern requirements. Design

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Glooko Device system for Glooko Logbook+ Application Special 510(k) Submission-K130886 510(k) Summarv Page 7 of 7

validation testing confirmed that the Glooko device performs according to the stated intended use. Device evaluation consisted of functional testing performed pursuant to Glooko's design verification protocol. which referenced FDA's guidance document for medical devices containing software. Such testing included Data Integrity Verification, Software Design/features Verification, and error handling testing. All test results fell within the pre-determined specification parameters.

Statement of Equivalence:

The Glooko Device System for Glooko Logbook+ Application is substantially equivalent to the predicate device with regards to its intended use and function. Both the subject and predicate devices use the exact same technology to download data from compatible FDA cleared blood glucose meters. Both the subject and predicate device are able to analyze blood glucose meter data producing basic statistics and graphs.

Summary:

Based on the information provided in this premarket notification, the Glooko device system for Glooko Logbook+ Application is substantially equivalent to the predicate device and is suitable for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Glooko, Inc. C/O Shilpa Mydur 170A University Avenue PALO ALTO CA 94301

. April 25, 2013

Re:K130886__________________________________________________________________________________________________________________________________________________________________

Trade/Device Name: Glooko Device System for Glooko Logbook+ Application Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JQP Dated: March 27, 2013 Received: March 29, 2013

Dear Shilpa Mydur:

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. 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for

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Page 2— Shilpa Mydur

the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Denise Johnson-lyles -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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Glooko Device system for Glooko Logbook+ Application Special 510(k) Submission Section 8-Indications for Use Statement Page 1 of 1

510(k) Number if Known: N/A

Device Name: Glooko Device System for Glooko Logbook+ Application

-Indications-for-Use:- The Glooko device system for Glooko Logbook+ Application is a data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Logbook+ Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their iPhone operating system platform.

The Glooko device system for Glooko Loabook+ Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR)

Katherine Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K130886

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.