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) ●

AI/ML Overview

The provided text describes the One Drop Blood Glucose Monitoring System (BGMS) and its submission for FDA 510(k) clearance. The document focuses on demonstrating substantial equivalence to a predicate device, the AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (K152365).

Based on the information provided, here is the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list "acceptance criteria" for the device's performance in a table format with corresponding "reported device performance." Instead, it establishes substantial equivalence by demonstrating that the One Drop BGMS has the same performance characteristics as the predicate device. The performance characteristics are implicitly considered "acceptance criteria" because they mirror those of the already-cleared predicate.

Performance Characteristic	Acceptance Criteria (from Predicate)	Reported Device Performance (One Drop BGMS)
Sample Type	Capillary whole blood	Same
Sample Sites	Fingertip	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
Power Source	(2) replaceable CR2032 3 volt, lithium batteries	Same
Connectivity	Meter can send BGM results via Bluetooth to smart devices using appropriate iOS or Android software application.	Same
Detection method	Dynamic Electrochemistry	Same
Enzyme	Glucose Oxidase	Same
Calibration Coding	Non-Coding	Same

The document explicitly states: "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)." And "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." This implies that the device's performance is expected to be identical to the predicate.

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

The provided text does not specify the sample size used for any performance testing of the One Drop BGMS, nor does it provide information on data provenance (e.g., country of origin, retrospective or prospective). The document relies on demonstrating substantial equivalence to the predicate device, implying that extensive de novo testing that would require such details might not have been included in this summary.

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

Since this is a submission for a blood glucose monitoring system, the "ground truth" for glucose measurements is typically established through a laboratory reference method (e.g., YSI analyzer) performed by trained laboratory technicians, not clinical "experts" in the sense of radiologists.

The document does not provide details on the number of laboratory personnel or their specific qualifications for establishing the ground truth for any testing conducted for the One Drop BGMS.

4. Adjudication Method for the Test Set

As the "ground truth" for blood glucose measurements is generally an objective laboratory reference method, an "adjudication method" involving multiple human readers as described (e.g., 2+1, 3+1) is not applicable to this type of device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is relevant for devices where human interpretation plays a significant role in diagnosis or decision-making (e.g., imaging studies). For a blood glucose monitoring system, which provides a direct numerical reading, an MRMC study comparing human readers with and without AI assistance is not applicable. The device is intended for self-testing by individuals with diabetes, not for interpretation by multiple clinical experts.

6. Standalone Performance Study

The provided document does not explicitly describe a standalone (algorithm only) performance study for the One Drop BGMS with detailed metrics. The submission focuses on establishing substantial equivalence to a predicate device, which implies that the underlying technology's standalone performance characteristics were already validated with the predicate. The document states that the fundamental scientific technology and electronics are the same as the predicate.

7. Type of Ground Truth Used

For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method for glucose measurement, such as a YSI glucose analyzer, which provides highly accurate and precise glucose values in blood samples. Details of this are not explicitly stated for the One Drop BGMS but would be standard for this type of device.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for any training set. Given the focus on substantial equivalence, if machine learning or AI was used in the development (which is not explicitly stated beyond "assay algorithm"), the training details are not disclosed in this summary.

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

The document does not provide information on how the ground truth for any training set was established. As with testing, if a training set were used for an algorithm, the ground truth would typically be established by a laboratory reference method.

Summary

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 Test Strips:

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
1. Submitter: AgaMatrix, Inc.
1. Address: 7C Raymond Ave. Salem, NH 03079 Phone: (603) 328-6000
1. Contact: David M. Olsen VP Quality Assurance / Regulatory Affairs dolsen@agamatrix.com Phone: 603-328-6049 Fax: 603-836-4025
1. 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, bloodglucose, 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) 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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Similarities
Item	Predicate DeviceAgaMatrix Jazz Wireless 2Blood Glucose MonitoringSystem(K152365)	Candidate DeviceOne Drop Blood GlucoseMonitoring System
IntendedUse/Indicationsfor Use	The AgaMatrix Jazz Wireless 2 BloodGlucose Monitoring System isintended for the quantitativemeasurement of blood glucose levelsin fresh capillary whole bloodsamples drawn from the fingertip. It isintended to be used by a single patientand should not be used for testingmultiple patients. The AgaMatrix JazzWireless 2 Blood Glucose MonitoringSystem is intended for self-testingoutside the body (In vitro diagnosticuse) by people with diabetes at homeas an aid to monitor the effectivenessof diabetes control. The AgaMatrixJazz Wireless 2 Blood GlucoseMonitoring System is not for thediagnosis of or screening for diabetes,and is not intended for use withneonates.The AgaMatrix Jazz Wireless 2 BloodGlucose Test Strips are for use with theAgaMatrix Jazz Wireless 2 GlucoseMeter to quantitatively measure bloodglucose (sugar) in fresh capillary wholeblood samples drawn from the fingertips.	The One Drop Blood Glucose MonitoringSystem is intended for the quantitativemeasurement of blood glucose levels infresh capillary whole blood samples drawnfrom the fingertip. It is intended to be usedby a single patient and should not be usedfor testing multiple patients. The OneDrop Blood Glucose Monitoring System isintended for self-testing outside the body(In vitro diagnostic use) by people withdiabetes at home as an aid to monitor theeffectiveness of diabetes control. The OneDrop Blood Glucose Monitoring System isnot for the diagnosis of or screening fordiabetes, and is not intended for use withneonates.The One Drop Blood Glucose Test Stripsare for use with the One Drop BloodGlucose Meter to quantitatively measureblood glucose (sugar) in fresh capillarywhole blood samples drawn from thefingertips.(Same as Predicate)
Similarities
Item	Predicate DeviceAgaMatrix Jazz Wireless 2Blood Glucose MonitoringSystem(K152365)	Candidate DeviceOne Drop Blood GlucoseMonitoring 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
OperatingTemperature	50° - 104°F	Same
MeasurementRange	20 to 600 mg/dL	Same
Calibration	Plasma Equivalent	Same
Control Levels	Two Levels	Same
OperatingHumidity	10% to 90%	Same
Hematocrit Range	20 - 60%	Same
Altitude Study	Up to 10,000 feet	Same
Similarities
Item	Predicate DeviceAgaMatrix Jazz Wireless 2Blood Glucose MonitoringSystem(K152365)	Candidate DeviceOne Drop Blood GlucoseMonitoring System
Power Source	(2) replaceable CR2032 3 volt,lithium batteries	Same
Connectivity	Meter can send BGM results viaBluetooth to smart devices using theappropriate iOS or Android softwareapplication.	Same
Detection method	Dynamic Electrochemistry	Same
Enzyme	Glucose Oxidase	Same
CalibrationCoding	Non-Coding	Same

10. Comparison to Predicate

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Differences
Item	Predicate Device	Candidate Device
	AgaMatrix Jazz Wireless 2Blood Glucose MonitoringSystem(K152365)	One Drop Blood Glucose MonitoringSystem
Meter size	L-2.56 inches, H-0.39 inches	L-2.76inches, H-0.47inches
Weight	18g	20g
Meter OuterFinish	ABS polymer blend with colorpigment added to polymer	ABS polymer blend covered with analuminum 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.

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.