(27 days)
Not Found
No
The summary describes a data management software for blood glucose readings, focusing on data transfer, review, analysis, and evaluation. There is no mention of AI, ML, or related technologies in the intended use, device description, or performance studies. The analysis and evaluation described appear to be standard data display and reporting, not advanced algorithmic processing.
No
The device is a data management software that aids in the review, analysis, and evaluation of blood glucose readings. It is explicitly stated that it is "not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice," indicating it does not directly treat or diagnose.
No
The device is described as a "data management software" that aids in the "review, analysis and evaluation of blood glucose readings". It explicitly states it is "not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice." This indicates it helps manage and display existing data rather than performing a diagnostic function itself.
No
The device description explicitly lists hardware components (Glooko MeterSync Cable, Glooko IR Adapter) as part of the system, indicating it is not software-only.
Based on the provided text, the Glooko device system for Glooko Logbook+ Application is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: IVDs are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Glooko's function: The Glooko system's primary function is to manage and display data from existing, FDA-cleared blood glucose meters. It does not perform any tests on biological specimens itself. It takes the results from the IVD (the blood glucose meter) and presents them in a user-friendly format.
- Intended Use: The intended use clearly states it's for "review, analysis and evaluation of blood glucose readings" and "to aid individuals with diabetes and their health care professionals." It explicitly states it's "not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice." This aligns with a data management tool, not a diagnostic tool.
- Device Description: The description reinforces that it "allows users to download readings from compatible, FDA-cleared, commercial blood glucose meters." It doesn't describe any components or processes for analyzing biological samples.
In summary, the Glooko system acts as a data aggregator and display tool for information generated by an IVD (the blood glucose meter), but it is not an IVD itself.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, JQP
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
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.
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
Home and professional 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)
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: The Glooko Device system (Glooko Logbook+ Application, Cable and Adapter) was validated pursuant to the moderate level of concern requirements. Design 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.
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
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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 Avenue
Palo Alto, CA 94301 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact: | Shilpa Mydur
Regulatory Affairs Manager
Phone: 650.720.5310
Email: 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 Management
System |
| 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 Logbook
Application and Glooko Logbook Charts (K122142) |
Device Description:
Overview
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.
1
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The Glooko device system for Logbook+ Application consists of the following components
-
- The Glooko MeterSync Cable
-
- The Glooko IR Adapter
-
- 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.
2
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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 for
Logbook Application and
Glooko Logbook Charts
(K122142) | Glooko Device System for
Glooko Logbook+ Application
(K130886) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software | Glooko Logbook Application | Glooko Logbook+ Application |
| Hardware | MeterSync Cable
IR Adapter | Same |
| Blood glucose meter
compatibility | Abbott: FreeStyle Freedom
Lite®, FreeStyle Lite®
Bayer: Bayer's BREEZE®2,
Bayer's CONTOUR®, Bayer's
CONTOUR® NEXT EZ, Bayer's
CONTOUR® XT
GLUCOCARD: GLUCOCARD®
01, GLUCOCARD® VitalTM
LifeScan: OneTouch® Ultra®2,
OneTouch® UltraLink®,
OneTouch® UltraMini®
ReliOn: ReliOn® Confirm,
ReliOn® Prime
Roche: 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's
CONTOUR® NEXT EZ, Bayer's
CONTOUR® XT
GLUCOCARD: GLUCOCARD® 01,
GLUCOCARD® VitalTM
LifeScan: OneTouch® Ultra®2,
OneTouch® UltraLink®,
OneTouch® UltraMini®
ReliOn: ReliOn® Confirm, ReliOn®
Prime
Roche: ACCU-CHEK® Aviva,
ACCU-CHEK® Aviva Nano, ACCU-
CHEK® Compact Plus, ACCU-
CHEK® Nano
CareSens N and CareSens N POP |
| Operating System | iOS 4.3 and higher | iOS 5.0 and higher |
| Hardware | • iPod touch®: 3rd and 4th
generations
• iPhone®: 3GS, 4, 4S
• iPad®: iPad 1, iPad 2, and
iPad (3rd generation) –
(Accessed in 2x mode) | • iPod touch®: 3rd and 4th
generations
• iPhone®: 3GS, 4, 4S
• iPad®: iPad 1, iPad 2, and iPad
(3rd generation) –(Accessed in 2x
mode)
• iPod touch 5th generation, iPhone
5, iPad mini, and iPad 4th
generation (These devices require
Apple's off-the-shelf Lightning to
30-pin adapter for connection.) |
| Syncs with compatible
meters | Yes | Yes |
| Allow users to
annotate readings with
notes | Yes | Yes |
| Product | Glooko device system for
Logbook Application and
Glooko Logbook Charts
(K122142) | Glooko Device System for
Glooko Logbook+ Application
(K130886) |
| Provide multiple view
options for the data | Yes | Yes.
Additionally, same data is
presented in different ways like List
View, Day View, Month View And
Logbook View. Readings in List
and Logbook views are color-coded
to indicate if they are high, low or
within range. These features were
added for user convenience. These
additional features did not raise any
new questions about safety and
effectiveness. |
| Share the collected
data | Yes | Yes |
| Provide statistics | Yes via supported web
download of Glooko Logbook
Charts from PC | Yes, across multiple devices and
supported web browsers. |
| Graph the glucose
readings | Yes via supported web
download of Glooko Logbook
Charts from PC | Yes, across multiple devices and
supported web browsers. |
| Allow goals to be set | No | Yes
Goals can be set to help motivate
healthy lifestyle choices. The five
goals that can be added are limited
to:
Test blood glucose regularly
Sync meter more often
Keep readings within range
Add meal tags to readings
Exercise more often.
This feature neither affects the
blood glucose data nor raises any
new questions of safety and
effectiveness. |
| Product | Glooko device system for
Logbook Application and
Glooko Logbook Charts
(K122142) | Glooko Device System for
Glooko Logbook+ Application
(K130886) |
| Transmit and view
data across supported
multiple devices and
web browsers using
consistent
authentication
credentials
(username/password) | No | Yes, 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, protecting
from unauthorized access over
wireless and wired networks. 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. |
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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.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
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
8
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