The Nova One Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous, arterial and fresh capillary whole blood from the finger and forearm. It is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use, auto-disabling lancets. The Nova One Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on neonates. Alternative site testing on the forearm should be used only during steady-state blood glucose conditions.

Device Description

The monitor is a hand-held testing device that works in conjunction with Nova One glucose test strips to measure glucose in a whole blood sample. Monitor operation is self-prompting using three user interface buttons. In addition to measuring glucose, the monitor also stores patient test and quality control test data.

The self-prompting menu system is navigated by means of a three-button keypad. It offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts.

A "battery low" warning will alert the user to change the batteries. Battery charge state information is available on the "monitor status screen". The user can select the auto shutoff option to conserve power when the monitor is not in use. Test data and monitor setup information will be stored in a nonvolatile format to prevent data loss.

The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0) and ferricyanide as a mediator and will utilize glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD) chemistry. The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood glucose result.

AI/ML Overview

The provided text describes the Nova One Blood Glucose Monitoring System, which is substantially equivalent to the previously cleared Nova Max One Blood Glucose Monitor System (K112638). The Nova One system has an expanded indication for use to include whole venous and arterial blood, in addition to capillary blood.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a discrete "acceptance criteria" table with numerical targets, but instead states the device's characteristics and its equivalence to a predicate device, implying that meeting the predicate device's performance is the acceptance criterion.

Characteristic	Predicate - Nova Max One Blood Glucose Monitor System - K112638 (Performance)	Proposed - Nova One Blood Glucose Monitor System (Performance)
Measuring Range	20-600 mg/dL	20-600 mg/dL
Operating Principle	Coulometric Electro-chemical Sensor	Coulometric Electro-chemical Sensor
Intended Use	Quantitative measurement of glucose in fresh capillary whole blood for single-patient home use. Not for diagnosis/screening for diabetes or neonates. AST on forearm only during steady-state.	Quantitative measurement of glucose in venous, arterial and fresh capillary whole blood from finger and forearm. For multiple-patient use in professional healthcare setting. Not for diagnosis/screening for diabetes or neonates. AST on forearm only during steady-state.
Hematocrit Range	25% to 60%	25% to 60%
Sample Type	Capillary blood from fingertip, forearm	Venous/Arterial blood and Capillary blood from fingertip, forearm
Sample Size	0.4 µL	0.4 µL
Glucose Units	mg/dL	mg/dL
Sample Application	Test strip capillary draw	Test strip capillary draw
Handheld meter?	Yes	Yes
Data Storage	Up to 400 blood glucose and control solution tests	Up to 400 blood glucose and control solution tests
Analysis Time	4 seconds	4 seconds
Insulin Tracking	No	No
Power Source	3 volt coin cell battery	3 volt coin cell battery
Test Strip Ejector	Yes	Yes
Test Strips Active Reagent	Glucose Dehydrogenase - FAD	Glucose Dehydrogenase - FAD
Test Strip Calibration Coding	No User Input of Calibration code required	No User Input of Calibration code required
Controls	Liquid, 3 levels	Liquid, 3 levels
Lancing Device	Nova Reusable Lancing Device and Lancets	Nova Single Use Disposable Safety Lancets

The text states: "The performance of the Nova One Blood Glucose Monitor was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that medical professionals can obtain blood glucose results from venous/arterial blood that are substantially equivalent to the current methods for blood glucose measurements obtained from capillary blood and in the central laboratory." And "Results of laboratory and clinical testing demonstrate that the Nova One Blood Glucose Monitor produces results that are substantially equivalent to results obtained on the predicate device."

2. Sample size used for the test set and the data provenance:

The document mentions "laboratory and clinical testing" but does not specify the sample size for the test set. It also does not explicitly state the country of origin of the data. The studies were likely prospective clinical studies given they involved healthcare professionals and lay users in "clinical settings," and "venous/arterial blood" for performance against central laboratory methods, which is typically collected prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not specify the number of experts used or their qualifications. It refers to "current methods for blood glucose measurements obtained... in the central laboratory," implying that the ground truth was established by standard laboratory procedures, which are overseen by qualified laboratory personnel and clinicians, but specific numbers or qualifications are not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document does not mention any adjudication method.

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 is a medical device for measuring blood glucose, not an AI-assisted diagnostic imaging or classification tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not done in this context.

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

The device (Nova One Blood Glucose Monitor) is inherently a standalone diagnostic tool. Its performance is measured directly by comparing its glucose readings against a reference method. The "algorithm" here is the electrochemical sensor and embedded software in the device, which performs its measurement without ongoing human interpretation during the actual glucose reading process. So, yes, a standalone performance evaluation was done implicitly through the "laboratory and clinical testing."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the test set was established by "current methods for blood glucose measurements obtained... in the central laboratory." This typically refers to a highly accurate reference laboratory method, such as a YSI glucose analyzer, which is considered the gold standard for glucose measurement.

8. The sample size for the training set:

The document does not specify a separate "training set" or its sample size. Given this is a medical device approval for a glucose meter, the "training" typically refers to the development and calibration of the device's internal algorithms during its engineering phase, rather than a distinct machine learning "training set" in the common AI sense. The substantial equivalence argument also relies on the previous K112638 clearance.

9. How the ground truth for the training set was established:

As mentioned above, the concept of a "training set" with ground truth in the AI sense is not explicitly present. The device's underlying technology is stated as being "the same fundamental scientific technology" as the predicate device (K112638). This implies that the design and calibration of the device were based on established glucose measurement principles and validated against reference laboratory methods during the development of the original Nova Max One system. The current submission focuses on demonstrating equivalence and expanded indications for use.

Summary

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510(k) Summary

DEC 2 0 2012

Date Prepared: A. August 8, 2012
B. 510(K) Owner:

Nova Biomedical Corporation 200 Prospect St. Waltham, MA 02454 USA Contact Person: Paul W. MacDonald Phone: 781-894-0800 Fax Number: 784-891-4806 Registration Number: 1219029

். Device Information

1. Proprietary Name: Nova One Blood Glucose Monitor
1. Common Or Usual Name: Blood Glucose Monitor
1. Classification Name: System, Test, Blood Glucose
1. Classification:

Class II (assay) and Class I, Reserved Controls

1. Product Codes:
  NBW, Blood Glucose Test System, Over-the-Counter

LFR, Glucose Dehydrogenase

JJX, Single (specified) analyte controls (assayed and unassayed)

6. Regulatory Section:

21 CFR 862.1345, Glucose Test System 21 CFR 862.1660, Quality Control (assayed and unassayed)

1. Panel:

Clinical Chemistry (75)

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D. Intended Use:

The Nova One Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous, arterial and fresh capillary whole blood from the finger and forearm. It is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of diabetes control program. This system should only be used with singleuse, auto-disabling lancets. The Nova One Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on neonates. Alternative site testing on the forearm should be used only during steady-state blood glucose conditions.

Limitation Statement: ய்
Venous and arterial whole blood collected in heparin tubes or syringes may be used for testing. EDTA is not recommended for use with the Nova One. Mix blood thoroughly before testing.

F. Device Description: .

Nova One Blood Glucose Monitor

The self-prompting menu system is navigated by means of a three-button keypad. It offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts.

Nova One Blood Glucose Test Strips

The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 ነህ) and ferricyanide as a mediator and will utilize glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD) chemistry. The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood glucose result. Ten test strips will be provided with the meter kit and will also be available separately in vials of 25 strips. These test strips are manufactured by Nova Biomedical to those cleared for market with the predicate Nova Max One Blood Glucose Monitor System (K112638).

Control Solutions

The control solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosityadjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls. One level of control (Level 2) will be supplied with the monitor kit and all three levels will be available for sale separately from the monitor. These controls are manufactured by Nova Biomedical and identical to those cleared for distribution with the predicate Nova Max One Blood Glucose Monitor System (K112638).

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Summary of Technological Characteristics: G.
The Nova One Blood Glucose Monitor is the same device cleared in K112638 (Nova Max One Glucose Monitor System) and has the same fundamental scientific technology. The Nova One Blood Glucose Monitor is substantially equivalent to the Nova Max One Blood Glucose Monitor.

The Nova One Blood Glucose Monitor measures glucose electrochemically as described in K112638 (Nova Max One Glucose Monitor System). In the same manner, the magnitude of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in whole blood and control solutions.

Predicate Device: H.

K112638 - Nova Max One Blood Glucose Monitor System . K080641 - Home Diagnostics Inc. TRUEresult Blood Glucose Monitor System

Comparison to Predicate Devices: 1.
The Nova One Blood Glucose Monitor is identical to the previously cleared Nova Max One Blood Glucose Monitor (K112638). It has the same fundamental scientific technology. The indication for use has been expanded to include whole venous and arterial blood, as well as capillary blood. No changes were made to any of the components of the system as compared to the cleared system (K112638). The Nova One Blood Glucose Monitor has the similar indications for use (whole venous and capillary blood) as the Home Diagnostics Inc. TRUEresult Blood Glucose Monitor System (K080641). The Nova One Blood Glucose Monitor is substantially equivalent to the Nova Max One Glucose Monitor System and the Home Diagnostics Inc. TRUEresult Blood Glucose Monitor System. Please see the table Comparison of Predicate and Proposed Devices below.

Performance Studies: ﺎ .

The performance of the Nova One Blood Glucose Monitor was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that medical professionals can obtain blood glucose results from venous/arterial blood that are substantially equivalent to the current methods for blood glucose measurements obtained from capillary blood and in the central laboratory.

. K Conclusion:

Results of laboratory and clinical testing demonstrate that the Nova One Blood Glucose Monitor produces results that are substantially equivalent to results obtained on the predicate device. The system performs as intended and raises no new safety or effectiveness issues.

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Characteristic	Predicate - Nova Max One Blood GlucoseMonitor System - K112638	Predicate - TRUEresult Blood GlucoseMonitor System - K080641	Proposed - Nova One Blood GlucoseMonitor System
Measuring Range	20-600 mg/dL	20-600 mg/dL	20-600 mg/dL
OperatingPrinciple	Coulometric Electro-chemical Sensor	Amperometric Electro-chemical Sensor	Coulometric Electro-chemical Sensor
Intended Use	The Nova Max One Blood Glucose Monitoris intended to be used for the quantitativemeasurement of glucose in fresh capillarywhole blood. It is intended for single-patienthome use and should not be used for testingmultiple patients. It is intended for selftesting outside the body by people withdiabetes mellitus as an aid to monitor theeffectiveness of diabetes control. The NovaMax One Blood Glucose Monitor isspecifically indicated for the quantitativemeasurement of glucose in fresh wholeblood capillary samples obtained from thefingertip or alternative site testing (AST) onthe forearm. AST on the forearm can beused only during steady-state blood glucoseconditions. It is not intended for thediagnosis of or screening for diabetes, and itis not intended for use on newborns.	The TRUEresult Blood Glucose System isintended for the quantitative determinationof glucose in human whole blood taken fromthe finger or forearm. The system isintended to be used to assist the patient andHealthcare Professional in the managementof diabetes.Healthcare Professionals may use thedevice to test venous whole blood; homeuse is limited to capillary whole bloodtesting.Not for neonatal use.	The Nova One Blood Glucose MonitoringSystem is intended to be used for thequantitative measurement of glucose invenous, arterial and fresh capillary wholeblood from the finger and forearm. It isintended for testing outside the body (in vitrodiagnostic use) and is intended for multiple-patient use in a professional healthcaresetting as an aid to monitor theeffectiveness of diabetes control program.This system should only be used withsingle-use, auto-disabling lancets.The Nova One Blood Glucose MonitoringSystem is not intended for the diagnosis ofor screening for diabetes, and it is notintended for use on neonates. Alternativesite testing on the forearm should be usedonly during steady-state blood glucoseconditions.Nova One Blood Glucose Test Strips are foruse with the Nova One Blood GlucoseMonitors for quantitatively measuringglucose in venous, arterial and freshcapillary whole blood from the finger andforearm.
HematocritRange	25% to 60%	20% to 60%	25% to 60%
Sample type	Capillary blood from the fingertip, forearm	Venous blood and Capillary blood from thefingertip, forearm	Venous/Arterial blood and Capillary bloodfrom the fingertip, forearm
Characteristic	Predicate - Nova Max One Blood GlucoseMonitor System - K112638	Predicate - TRUEresult Blood GlucoseMonitor System – K080641	Proposed - Nova One Blood GlucoseMonitor System
Sample size	0.4 µL	0.5 µL	0.4 µL
Glucose Units	mg/dL	mg/dL	mg/dL
SampleApplication	Test strip capillary draw	Test strip capillary draw	Test strip capillary draw
Handheld meter?	Yes	Yes	Yes
Data storage	Up to 400 blood glucose and control solutiontests	Up to 500 blood glucose and control solutiontests	Up to 400 blood glucose and control solutiontests
Analysis Time	4 seconds	4 seconds	4 seconds
Insulin Tracking	No.	No	No.
Power source	3 volt coin cell battery	3 volt coin cell battery	3 volt coin cell battery
Test Strip Ejector	Yes	No	Yes
Test StripsActive reagent:	Glucose Dehydrogenase - FAD	Glucose Dehydrogenase - PQQ	Glucose Dehydrogenase - FAD
Test StripCalibrationCoding	No User Input of Calibration code required	No User Input of Calibration code required	No User Input of Calibration code required
Accessories:
Controls:	Liquid, 3 levels	Liquid, 3 levels	Liquid, 3 levels
Lancing Device:	Nova Reusable Lancing Device and Lancets	Reusable Lancing Device and Lancets	Nova Single Use Disposable Safety Lancets

Comparison of Predicate and Proposed device

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration

Public Health Service '

10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 20, 2012

Nova Biomedical Corporation c/o Paul W. MacDonald 200 Prospect Street Waltham; MA 02454

Re: K122435

Trade/Device Name: Nova One Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: NBW, LFR, JJX Dated: December 12, 2012 Received: December 17, 2012

Dear Mr. MacDonald:

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. Iisting 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.

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Page 2-Mr. MacDonald

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. Benson 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):

Device Name:

K122435 Nova One Blood Glucose Monitor

Indications for Use:

The Nova One Blood Glucose Monitoring System is intended to be used for the quantitative me Nova Ont Group Choose in venous, arterial and fresh capillary whole blood from the finger and forearm. It is intended for testing outside the body (in vitro diagnostic use) and is intended for foroum. It is monebular in a professional healthcare setting as an aid to monitor the effectiveness of maniple patient be man. This system should only be used with single-use, auto-disabling diabetes control program "Tod Cyccore Monitoring System is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on neonates. Alternative site testing on the forearm should be used only during steady-state blood glucose conditions.

Nova One Blood Glucose Test Strips are for use with the Nova One Blood Glucose Monitors for quantitatively measuring glucose in venous, arterial and fresh capillary whole blood from the quantitatively modisoning glasses in vehicles calibrated to provide plasma equivalent results to linger and forsam. "The One Glucose Test Strips are for testing outside the body (in vitro diagnostic use only). The Nova One Blood Glucose Monitor should only be used as directed. diagnostic ass only). The NoTa One Broof or screening for diabetes, and are not intended for use on newborns.

Nova Max Control Solutions are intended for use with the Nova Max, Nova Max One and Nova North max Glucose Monitoring Systems as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Levels 1, 2, 3).

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Kattlu Semmo

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K122435

Page 1 of 1

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.