Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard blood glucose monitoring system using enzymatic chemistry and basic electronic processing, with no mention of AI or ML algorithms for data analysis, interpretation, or prediction.

Therapeutic

No
The device is intended for in vitro diagnostic use to measure glucose levels, aiding in monitoring the effectiveness of a diabetes control program, but it does not directly treat or prevent a disease.

Diagnostic

Yes

The device is intended for the quantitative measurement of glucose in blood and is used as an "aid to monitor the effectiveness of diabetes control program" which is a diagnostic purpose. It is also explicitly stated as "in vitro diagnostic use".

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical hand-held testing device (monitor) that works in conjunction with test strips. It describes hardware components like user interface buttons, a keypad, a battery, and a nonvolatile storage format. This is not a software-only device.

IVD (In Vitro Diagnostic)

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

The "Intended Use / Indications for Use" section explicitly states: "It is intended for testing outside the body (in vitro diagnostic use)". This statement directly identifies the device as an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 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.

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 finger and forearm.

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

NBW, LFR, JJX

Device Description

Nova One Blood Glucose Monitor

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.

Nova One Blood Glucose Test Strips

The test strips contain a reaction layer that contains a glucose-enzyme (> 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. 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, viscosity-adjusting 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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

finger, forearm

Indicated Patient Age Range

The Nova One Blood Glucose Monitoring System is not intended for use on neonates.

Intended User / Care Setting

multiple-patient use in a professional healthcare setting

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 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.

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.

K112638, K080641

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

0

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)

1

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.

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 finger and forearm.

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 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.

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.

3

| Characteristic | Predicate - Nova Max One Blood Glucose
Monitor System - K112638 | Predicate - TRUEresult Blood Glucose
Monitor System - K080641 | Proposed - Nova One Blood Glucose
Monitor System |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measuring Range | 20-600 mg/dL | 20-600 mg/dL | 20-600 mg/dL |
| Operating
Principle | Coulometric Electro-chemical Sensor | Amperometric Electro-chemical Sensor | Coulometric Electro-chemical Sensor |
| Intended Use | The Nova Max One Blood Glucose Monitor
is intended to be used for the quantitative
measurement of glucose in fresh capillary
whole blood. It is intended for single-patient
home use and should not be used for testing
multiple patients. It is intended for self
testing outside the body by people with
diabetes mellitus as an aid to monitor the
effectiveness of diabetes control. The Nova
Max One Blood Glucose Monitor is
specifically indicated for the quantitative
measurement of glucose in fresh whole
blood capillary samples obtained from the
fingertip or alternative site testing (AST) on
the forearm. AST on the forearm can be
used only during steady-state blood glucose
conditions. It is not intended for the
diagnosis of or screening for diabetes, and it
is not intended for use on newborns. | The TRUEresult Blood Glucose System is
intended for the quantitative determination
of glucose in human whole blood taken from
the finger or forearm. The system is
intended to be used to assist the patient and
Healthcare Professional in the management
of diabetes.

Healthcare Professionals may use the
device to test venous whole blood; home
use is limited to capillary whole blood
testing.

Not for neonatal 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
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.

.

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.

6

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 .

7

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

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