One Drop Blood Glucose Monitoring System

• K Number: K161834
• Device Name: One Drop Blood Glucose Monitoring System
• Manufacturer: AgaMatrix, Inc.
• Date Cleared: 2016-11-30 ( 148 days)
• Product Code: NBW CGA
• Regulation Number: 862.1345

Intended Use

The One Drop Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop Blood Glucose Monitoring System 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. The One Drop Blood Glucose Monitoring System is not for the diagnosis of, or diabetes, and is not intended for use with neonates. The One Drop Blood Glucose Test Strips: The One Drop Blood Glucose Test Strips are for use with the One Drop Blood Glucose Meter to quantitatively measure blood glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Device Description

The One Drop Blood Glucose Monitoring System (BGMS) is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop BGMS 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. The System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates. The system measures the concentration of glucose in a drop of blood obtained from the fingertip. The test strip is inserted into the meter and the blood is then introduced to the tip of the test strip. The blood reacts with chemicals on the test strip and this reaction generates an electrical current which is measured by the meter. The magnitude of the current is related to the blood glucose concentration. The fundamental scientific technology and the electronics that sends the electrical signals to the assay algorithm are all the same as the predicate device AgaMatrix Jazz Wireless 2 BGMS (K152365). The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user. The One Drop Blood Glucose Monitoring System (BGMS) consists of: - 1 One Drop Blood Glucose Meter ● - 1 One Drop Owner's Guide ● - 1 Carry Case - 1 Lancing Device - 10 Lancets - 100 One Drop Glucose Test Strips ● - AgaMatrix Glucose Control Solution (available separately) ●

Predicate Devices

K152365

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the electrochemical measurement of glucose and does not mention any AI or ML components. The technology is described as the same as the predicate device, which is a standard blood glucose meter.

Therapeutic

No
The device is a blood glucose monitoring system, used for measuring blood glucose levels, which aids in monitoring diabetes control but does not directly treat the condition.

Diagnostic

No

The text explicitly states: "The One Drop Blood Glucose Monitoring System is not for the diagnosis of, or diabetes..." and "The System is not for the diagnosis of, or screening for diabetes". While it measures glucose levels, it is intended for monitoring the effectiveness of diabetes control, not for initial diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a blood glucose meter, test strips, lancing device, and lancets, indicating it is a hardware-based system with software components, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The text explicitly states in multiple places:

• "The One Drop Blood Glucose Monitoring System is intended for self-testing outside the body (In vitro diagnostic use) by people with diabetes at home..." (Intended Use / Indications for Use)
• "The One Drop BGMS is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home..." (Device Description)

This clearly indicates that the device is intended for diagnostic testing performed on samples taken from the body, which is the definition of an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The One Drop Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop Blood Glucose Monitoring System 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. The One Drop Blood Glucose Monitoring System is not for the diagnosis of, or diabetes, and is not intended for use with neonates.

The One Drop Blood Glucose Test Strips:
The One Drop Blood Glucose Test Strips are for use with the One Drop Blood Glucose Meter to quantitatively measure blood glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Product codes (comma separated list FDA assigned to the subject device)

NBW, CGA

Device Description

The One Drop Blood Glucose Monitoring System (BGMS) is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop BGMS 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. The System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.

The system measures the concentration of glucose in a drop of blood obtained from the fingertip. The test strip is inserted into the meter and the blood is then introduced to the tip of the test strip. The blood reacts with chemicals on the test strip and this reaction generates an electrical current which is measured by the meter. The magnitude of the current is related to the blood glucose concentration. The fundamental scientific technology and the electronics that sends the electrical signals to the assay algorithm are all the same as the predicate device AgaMatrix Jazz Wireless 2 BGMS (K152365). The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user.

The One Drop Blood Glucose Monitoring System (BGMS) consists of:

• 1 One Drop Blood Glucose Meter ●
• 1 One Drop Owner's Guide ●
• 1 Carry Case
• 1 Lancing Device
• 10 Lancets
• 100 One Drop Glucose Test Strips ●
• AgaMatrix Glucose Control Solution (available separately) ●

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Fingertip

Indicated Patient Age Range

The One Drop Blood Glucose Monitoring System is not for the diagnosis of, or diabetes, and is not intended for use with neonates.

Intended User / Care Setting

self-testing outside the body (In vitro diagnostic use) by people with diabetes at home

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)

Not Found

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.

K152365

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

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.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS logo, which consists of a stylized caduceus with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.

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

AGAMATRIX, INC. DAVID OLSEN VP QUALITY & REGULATORY AFFAIRS 7C RAYMOND AVE. SALEM NH 03079

November 30, 2016

Re: K161834

Trade/Device Name: One Drop Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: November 01, 2016 Received: November 02, 2016

Dear Mr. David Olsen:

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 Parts 801 and 809); 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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Katherine Serrano -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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Indications for Use

510(k) Number (if known) K161834

Device Name

One Drop Blood Glucose Monitoring System

Indications for Use (Describe)

The One Drop Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop Blood Glucose Monitoring System 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. The One Drop Blood Glucose Monitoring System is not for the diagnosis of, or diabetes, and is not intended for use with neonates.

The One Drop Blood Glucose Test Strips:

The One Drop Blood Glucose Test Strips are for use with the One Drop Blood Glucose Meter to quantitatively measure blood glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

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)

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510 (k) Section 15

510(k) Summary Rev. 092716

This summary of 510(k) substantial equivalence is being submitted in accordance with the requirements of 21 CFR 807.92.

• 1. Prepared: June 29, 2016
• 2. Submitter: AgaMatrix, Inc.
• 3. Address: 7C Raymond Ave. Salem, NH 03079 Phone: [phone]
• 4. Contact: David M. Olsen VP Quality Assurance / Regulatory Affairs [e-mail] Phone: [phone] Fax: [phone]
• 5. Device Name: Trade/Proprietary Name: One Drop Blood Glucose Monitoring System Common Name: Glucose Test System

6. Device Classification:

Product Code	Classification	Regulation	Pan
CGA – glucose Oxidase	Class II	21 CFR 862.1345	75, Clinical Chemistry
NBW – system, test, blood
glucose, over the counter	Class II	21 CFR 862.1345	75, Clinical Chemistry

7. Predicate Device:

AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System, 510(k) K152365

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8. Device Description:

The One Drop Blood Glucose Monitoring System (BGMS) is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop BGMS 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. The System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.

The system measures the concentration of glucose in a drop of blood obtained from the fingertip. The test strip is inserted into the meter and the blood is then introduced to the tip of the test strip. The blood reacts with chemicals on the test strip and this reaction generates an electrical current which is measured by the meter. The magnitude of the current is related to the blood glucose concentration. The fundamental scientific technology and the electronics that sends the electrical signals to the assay algorithm are all the same as the predicate device AgaMatrix Jazz Wireless 2 BGMS (K152365). The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user.

The One Drop Blood Glucose Monitoring System (BGMS) consists of:

• 1 One Drop Blood Glucose Meter ●
• 1 One Drop Owner's Guide ●
• 1 Carry Case
• 1 Lancing Device
• 10 Lancets
• 100 One Drop Glucose Test Strips ●
• AgaMatrix Glucose Control Solution (available separately) ●

9. Intended Use & Indications for Use:

9.1. Intended Use:

Blood Glucose Monitoring

9.2. Indications for Use:

The One Drop Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop Blood Glucose Monitoring System 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. The One Drop Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.

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The One Drop Blood Glucose Test Strips are for use with the One Drop Blood Glucose Meter to quantitatively measure blood glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Similarities
Item	Predicate Device
AgaMatrix Jazz Wireless 2
Blood Glucose Monitoring
System
(K152365)	Candidate Device
One Drop Blood Glucose
Monitoring System
Intended
Use/Indications
for Use	The AgaMatrix Jazz Wireless 2 Blood
Glucose Monitoring System is
intended for the quantitative
measurement of blood glucose levels
in fresh capillary whole blood
samples drawn from the fingertip. It is
intended to be used by a single patient
and should not be used for testing
multiple patients. The AgaMatrix Jazz
Wireless 2 Blood Glucose Monitoring
System 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. The AgaMatrix
Jazz Wireless 2 Blood Glucose
Monitoring System is not for the
diagnosis of or screening for diabetes,
and is not intended for use with
neonates.
The AgaMatrix Jazz Wireless 2 Blood
Glucose Test Strips are for use with the
AgaMatrix Jazz Wireless 2 Glucose
Meter to quantitatively measure blood
glucose (sugar) in fresh capillary whole
blood samples drawn from the fingertips.	The One Drop Blood Glucose Monitoring
System is intended for the quantitative
measurement of blood glucose levels in
fresh capillary whole blood samples drawn
from the fingertip. It is intended to be used
by a single patient and should not be used
for testing multiple patients. The One
Drop Blood Glucose Monitoring System 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. The One
Drop Blood Glucose Monitoring System is
not for the diagnosis of or screening for
diabetes, and is not intended for use with
neonates.
The One Drop Blood Glucose Test Strips
are for use with the One Drop Blood
Glucose Meter to quantitatively measure
blood glucose (sugar) in fresh capillary
whole blood samples drawn from the
fingertips.
(Same as Predicate)
Similarities
Item	Predicate Device
AgaMatrix Jazz Wireless 2
Blood Glucose Monitoring
System
(K152365)	Candidate Device
One Drop Blood Glucose
Monitoring System
Sample Type	Capillary whole blood	Same
Sample Sites	Finger tip	Same
Sample Volume	0.5 µL	Same
Average Test Time	5 seconds	Same
Test range	20 - 600 mg/dL	Same
Operating
Temperature	50° - 104°F	Same
Measurement
Range	20 to 600 mg/dL	Same
Calibration	Plasma Equivalent	Same
Control Levels	Two Levels	Same
Operating
Humidity	10% to 90%	Same
Hematocrit Range	20 - 60%	Same
Altitude Study	Up to 10,000 feet	Same
Similarities
Item	Predicate Device
AgaMatrix Jazz Wireless 2
Blood Glucose Monitoring
System
(K152365)	Candidate Device
One Drop Blood Glucose
Monitoring System
Power Source	(2) replaceable CR2032 3 volt,
lithium batteries	Same
Connectivity	Meter can send BGM results via
Bluetooth to smart devices using the
appropriate iOS or Android software
application.	Same
Detection method	Dynamic Electrochemistry	Same
Enzyme	Glucose Oxidase	Same
Calibration
Coding	Non-Coding	Same

10. Comparison to Predicate

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Differences
Item	Predicate Device	Candidate Device
	AgaMatrix Jazz Wireless 2
Blood Glucose Monitoring
System
(K152365)	One Drop Blood Glucose Monitoring
System
Meter size	L-2.56 inches, H-0.39 inches	L-2.76inches, H-0.47inches
Weight	18g	20g
Meter Outer
Finish	ABS polymer blend with color
pigment added to polymer	ABS polymer blend covered with an
aluminum plating

11. Technological Characteristics:

The device modifications described in this premarket notification do not affect or alter the fundamental scientific technology of the predicate device, the AgaMatrix Jazz Wireless 2 Blood Glucose Monitor.

12. Intended Use:

The modifications described in this premarket notification do not alter or change the intended use of the modified device from its predicate the AgaMatrix Jazz Wireless 2 Blood Glucose Monitor.