NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR

K122688 · Nova Biomedical Corporation · LFR · Apr 4, 2013 · Clinical Chemistry

Device Facts

• Record ID: K122688
• Device Name: NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
• Applicant: Nova Biomedical Corporation
• Product Code: LFR · Clinical Chemistry
• Decision Date: Apr 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nova Max Mini Blood Glucose and β-Ketone Monitor System is intended to be used for the quantitative measurement of glucose or β-hydroxybutyrate (β-ketone) 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 Mini Blood Glucose and β-Ketone Monitor System is specifically indicated for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip or alternative site testing on the forearm, or β-ketone in whole blood capillary samples obtained from the fingertip only. Glucose AST on the forearm can be used only during steady-state blood glucose conditions. The Nova Max Mini is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on neonates. The Nova Max Mini Blood Glucose Test Strips are intended for use only with the Nova Max Mini Blood Glucose Monitor System to quantitatively measure capillary blood glucose from the finger and forearm. The Nova Max Mini Ketone Test Strips are intended for use only on the Nova Max Mini Blood Glucose and β-Ketone Monitor System to quantitatively measure capillary β-hydroxybutyrate from the finger. Nova Max Mini Glucose/Ketone Control Solutions are intended for use with the Max Mini Glucose or β-Ketone Test Strips as a quality control check to verify the accuracy of test results. There are two levels of controls, (Level 2 and Level 3).

Device Story

Handheld monitor system for quantitative measurement of glucose and β-hydroxybutyrate (β-ketone) in capillary whole blood. Uses electrochemical biosensor technology; glucose dehydrogenase-FAD for glucose; β-hydroxybutyrate dehydrogenase for ketones. User applies blood sample to test strip via capillary action; meter measures resulting electrical current proportional to analyte concentration. Designed for single-patient home use by individuals with diabetes. Provides digital readout of results; stores up to 400 tests. Includes control solutions for accuracy verification. Benefits patients by enabling self-monitoring of diabetes control and ketone levels to aid in management.

Clinical Evidence

Bench testing only. Precision studies performed using heparinized venous whole blood across multiple concentrations (N=90 per glucose level; N=20 per ketone level). Method comparison studies conducted against YSI reference method (glucose) and enzymatic spectroscopy (ketone) with 100 samples each, demonstrating high correlation (R²=0.9953 for glucose; R²=0.9931 for ketone). Usability study with 40 participants confirmed ease of use and ability to differentiate between test types.

Technological Characteristics

Coulometric electrochemical sensor; glucose measurement via GDH-FAD (Aspergillus sp.); ketone measurement via ß-hydroxybutyrate dehydrogenase (Alcaligenes fecalis). Hand-held form factor; 3V coin cell battery; non-volatile data storage. No user calibration coding required.

Indications for Use

Indicated for people with diabetes mellitus for self-testing of blood glucose or ß-hydroxybutyrate (ß-ketone) to monitor diabetes control effectiveness. Not for neonates, diagnosis, or screening. Glucose testing via fingertip or forearm (steady-state only); ketone testing via fingertip only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Nova Max Plus Blood Glucose and β-Ketone Monitor System (k091547)
• Nova Max One Blood Glucose Monitor System (k112638)
• Nova Max Plus Glucose and β-Ketone Control Solutions (k101633)

Submission Summary (Full Text)

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K122688

## 510(k) Summary

A. Date Prepared: November 8. 2012

B. 510(K) Owner:

> Nova Biomedical Corporation 200 Prospect St. Waltham, MA 02454 USA Contact Person: Paul W. MacDonald Phone: [phone] Fax Number: 784-891-4806 Registration Number: 1219029

். Device Information

Proprietary Name:

Nova Max Mini Blood Glucose and ß-Ketone Monitor System

Common Or Usual Name:

Blood Glucose and ß-Ketone Monitor

Classification Name:

System, Test, Blood Glucose, Over the Counter

- 4. Classification:
Class II (assay) and Class I, Reserved Controls

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

LFR, Glucose Dehydrogenase

JJY, Multi-Analyte Controls

JIN, Ketones

6. Regulatory Section:

21 CFR 862.1345, Glucose Test System

21 CFR 862.1660, Quality Control (assayed and unassayed)

21 CFR 862.1435, Ketone Test System

7. Panel:

Clinical Chemistry (75)

- D. Intended Use:
The Nova Max Mini Blood Glucose and ß-Ketone Monitor System is intended to be used for the quantitative measurement of glucose or ß-hydroxybutyrate (ß-ketone) 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 Mini Blood Glucose and ß-Ketone Monitor System is specifically indicated for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip or alternative site testing on the forearm, or ß-ketone in whole blood capillary samples

APR 4 2013

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obtained from the fingertip only. Glucose AST on the forearm can be used only during steady-state blood glucose conditions.

The Nova Max Mini is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on neonates.

The Nova Max Mini Blood Glucose Test Strips are intended for use only with the Nova Max Mini Blood Glucose Monitor System to quantitatively measure capillary blood glucose from the finger and forearm.

The Nova Max Mini Ketone Test Strips are intended for use only on the Nova Max Mini Blood Glucose and ß-Ketone Monitor System to quantitatively measure capillary Bhydroxybutyrate from the finger.

Nova Max Mini Glucose/Ketone Control Solutions are intended for use with the Nova Max Mini Glucose and ß-Ketone Monitor and test strips as a quality control check to verify the accuracy of test results. There are two levels of controls, (Level 2 and Level 3).

ய Device Description:

Nova Max Mini Blood Glucose and ß-Ketone Monitor

The monitor is a hand-held testing device that works in conjunction with Nova Max Mini glucose test strips to measure glucose or the Nova Max Mini β-Ketone test strips to measure ß-ketone in a whole blood sample. Monitor operation is self-prompting using three user interface buttons. In addition to measuring glucose and ketone, 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 non-volatile format to prevent data loss.

Nova Max Mini Blood Glucose Test Strips

The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricyanide as a mediator and will utilize glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD) chemistry (Aspergillis sp.). 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 end of 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 50 strips. These test strips are manufactured by Nova Biomedical and identical to those cleared for market with the predicate Nova Max One Blood Glucose Monitor System (K112638).

Nova Max Mini ß-Ketone Test Strips

The Nova Max Mini β-Ketone test strips contain a reaction layer that contains the enzyme βhydroxybutyrate dehydrogenase (Alcaligenes fecalis) greater than or equal to 0.3 IU; mediator greater than or equal to 0.42 µg: coenzyme equal or greater than 0.28 µg and additional ingredients (polymers, buffers). 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 end of the strip, the blood is drawn into the reaction space via capillary action. This simple one-step process provides a blood ß-Ketone result displayed on the monitor. Two ketone test strips will be provided with the meter kit and will also be available separately in cartons of 10 strips. Ketone strips are individually packaged in foil pouches. The ketone test strip is identical to the strip cleared for market with the predicate Nova Max Plus Blood Glucose and ß-Ketone Monitor (K091547).

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## Control Solutions

The control solutions are aqueous assayed solutions, containing buffered D-Glucose. B-Ketone, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are two levels of controls, (Level 2 and Level 3). One level of control (Level 2) will be provided with the monitor and both levels will be available for sale separately from the monitor. These controls are manufactured by Nova Biomedical and identical to those cleared for market as Nova Max Plus Glucose and β-Ketone Control Solution (Κ101633).

- に Summary of Technological Characteristics:
The Nova Max Mini Blood Glucose and β-Ketone Monitor is the same device cleared in K091547 (Nova Max Plus Blood Glucose and β-Ketone Monitor System) and K112638 (Nova Max One Blood Glucose Monitor) and has the same fundamental scientific technology. The Nova Max Mini Blood Glucose and ß-Ketone Monitor is substantially equivalent to the Nova Max Plus Blood Glucose and β-Ketone Monitor and the Nova Max One Blood Glucose Monitor.

The Nova Max Mini Blood Glucose Monitor measures glucose electrochemically as described in K112638 (Nova Max One Glucose Monitor System) and measures ketone electrochemically as described in K091547 (Nova Max Plus Blood Glucose and B-Ketone Monitor). In the same manner, the magnitude of the current is proportional to the amount of glucose or ketone present in the sample, providing a quantitative measure of glucose or ketone in whole blood and control solutions.

- G. Predicate Device:
K091547 - Nova Max Plus Blood Glucose and β-Ketone Monitor System K112638 - Nova Max One Blood Glucose Monitor System

- H. Comparison to Predicate Devices:
The Nova Max Mini Blood Glucose and β-Ketone Monitor, while smaller than both the Nova Max Plus (K091547) and the Nova Max One (K112638) Monitors, has the same fundamental scientific technology and user interface. The only changes made to the components of the system as compared to the cleared systems (K091547 and K112638) are the smaller housing and display. The Nova Max Mini Monitor has the same indications for use as the Nova Max Plus Monitor System and uses the same technology for glucose measurement as the Nova Max One Monitor System. The Nova Max Mini Blood Glucose and ß-Ketone Monitor is substantially equivalent to the Nova Max Plus Blood Glucose ß-Ketone and Nova Max One Glucose Monitor System. Please see the table Comparison of Predicate and Proposed Devices below.

- l. Performance Studies:
The performance of the Nova Max Mini Blood Glucose and β-Ketone Monitor was studied in the laboratory settings. The studies demonstrated that the device can provide glucose or ketone results that are substantially equivalent to the current methods for blood glucose and ketone measurements obtained from capillary blood.

- J. Conclusion:
Results of laboratory testing demonstrate that the Nova Max Mini Blood Glucose and ß-Ketone Monitor produces results that are substantially equivalent to results obtained on the predicate devices. The system performs as intended and raises no new safety or effectiveness issues.

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Comparison of Predicate and Proposed device

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| Characteristic | Predicate - Nova Max One Blood<br>Glucose Monitor System - K112638 | Predicate – Nova Max Plus Blood<br>Glucose and β-Ketone Monitor System -<br>K091547 | Proposed - Nova Max Mini Blood<br>Glucose and β-Ketone Monitor System |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Measured | Glucose | Glucose or β-Ketone | Glucose or β-Ketone |
| Operating<br>Principle | Coulometric Electro-chemical Sensor | Coulometric Electro-chemical Sensor | Coulometric Electro-chemical Sensor |
| Intended Use | The Nova Max One Blood Glucose<br>Monitor is intended to be used for the<br>quantitative measurement of glucose<br>in fresh capillary whole blood. It is<br>intended for single-patient home use<br>and should not be used for testing<br>multiple patients. It is intended for<br>self testing outside the body by<br>people with diabetes mellitus as an<br>aid to monitor the effectiveness of<br>diabetes control. The Nova Max One<br>Blood Glucose Monitor is specifically<br>indicated for the quantitative<br>measurement of glucose in fresh<br>whole blood capillary samples<br>obtained from the fingertip or<br>alternative site testing (AST) on the<br>forearm. AST on the forearm can be<br>used only during steady-state blood<br>glucose conditions. It is not intended<br>for the diagnosis of or screening for<br>diabetes, and it is not intended for<br>use on newborns. | The Nova Max Plus Glucose and β-<br>Ketone Monitoring System is intended to<br>be used for the quantitative measurement<br>of glucose or β-hydroxybutyrate (β-<br>Ketone) in fresh capillary whole blood. It<br>is intended for use by people with<br>diabetes mellitus in the home and by<br>healthcare professionals in clinical<br>settings as an aid to monitor the<br>effectiveness of diabetes control. It is not<br>intended for use in the diagnosis of or<br>screening for diabetes mellitus and is not<br>intended for use on neonates. The Nova<br>Max Plus Monitor is specifically indicated<br>for the quantitative measurement of<br>glucose in fresh capillary whole blood<br>samples obtained from the fingertip,<br>forearm, and palm or β-ketone in fresh<br>capillary whole blood samples obtained<br>from the fingertip only. | The Nova Max Mini Blood Glucose and β-<br>Ketone Monitor System is intended to be<br>used for the quantitative measurement of<br>glucose or β-hydroxybutyrate (β-ketone)<br>in fresh capillary whole blood. It is<br>intended for single-patient home use and<br>should not be used for testing multiple<br>patients. It is intended for self-testing<br>outside the body by people with diabetes<br>mellitus as an aid to monitor the<br>effectiveness of diabetes control. The<br>Nova Max Mini Blood Glucose and β-<br>Ketone Monitor System is specifically<br>indicated for the quantitative<br>measurement of glucose in fresh capillary<br>whole blood obtained from the fingertip or<br>alternative site testing on the forearm, or<br>β-ketone in whole blood capillary samples<br>obtained from the fingertip only. Glucose<br>AST on the forearm can be used only<br>during steady-state blood glucose<br>conditions.<br>The Nova Max Mini is not intended for the<br>diagnosis of or screening for diabetes,<br>and it is not intended for use on neonates. |
| Characteristic | Predicate - Nova Max One Blood<br>Glucose Monitor System - K112638 | Predicate - Nova Max Plus Blood<br>Glucose and β-Ketone Monitor System -<br>K091547 | Proposed - Nova Max Mini Blood<br>Glucose and β-Ketone Monitor System |
| | | | The Nova Max Mini Blood Glucose Test<br>Strips are intended for use only with the<br>Nova Max Mini Blood Glucose Monitor<br>System to quantitatively measure<br>capillary blood glucose from the finger<br>and forearm.<br><br>The Nova Max Mini Ketone Test Strips<br>are intended for use only on the Nova<br>Max Mini Blood Glucose and β-Ketone<br>Monitor System to quantitatively measure<br>capillary β-hydroxybutyrate from the<br>finger.<br><br>Nova Max Mini Glucose/Ketone Control<br>Solutions are intended for use with the<br>Nova Max Mini Glucose and β-Ketone<br>Monitor and test strips as a quality control<br>check to verify the accuracy of test<br>results. There are two levels of controls,<br>(Level 2 and Level 3). |
| Measuring<br>Range | 20-600 mg/dL | 20-600 mg/dL | 20-600 mg/dL |
| KET Measuring<br>Range | N/A | 0.1 – 8.0 mmol/L | 0.1 - 8.0 mmol/L |
| Hematocrit<br>Range | 25% to 60% | 25% to 60% | 25% to 60% |
| Sample type | Capillary blood from the fingertip,<br>forearm | Capillary blood from the fingertip, forearm<br>and palm (Ketone fingertip only) | Capillary blood from the fingertip, forearm<br>(Ketone fingertip only) |
| GLU Sample | 0.4 µL | 0.3 µL | 0.4 µL |
| Characteristic | Predicate - Nova Max One Blood<br>Glucose Monitor System - K112638 | Predicate – Nova Max Plus Blood<br>Glucose and β-Ketone Monitor System –<br>K091547 | Proposed - Nova Max Mini Blood<br>Glucose and β-Ketone Monitor System |
| Glucose Units | mg/dL | mg/dL | mg/dL |
| Ketone Units | N/A | mmol/L | mmol/L |
| Sample<br>application | 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<br>solution tests | Up to 400 blood glucose and control<br>solution tests | Up to 400 blood glucose and control<br>solution tests |
| GLU Analysis<br>Time | 4 seconds | 5 seconds | 4 seconds |
| Insulin Tracking | No. | No | No. |
| KET Analysis<br>Time | N/A | 10 seconds | 10 seconds |
| Power source | 3 volt coin cell battery | 3 volt coin cell battery | 3 volt coin cell battery |
| GLU Test Strips<br>Active reagent: | Glucose, Dehydrogenase - FAD | Glucose Oxidase | Glucose Dehydrogenase - FAD |
| KET Test Strips<br>Active reagent | N/A | β-hydroxybutyrate dehydrogenase | β-hydroxybutyrate dehydrogenase |
| Test Strip<br>Calibration<br>Coding | No User Input of Calibration code<br>required | No User Input of Calibration code<br>required | No User Input of Calibration code<br>required |
| Lancing Device: | Nova Reusable Lancing Device and<br>Lancets | Nova Reusable Lancing Device and<br>Lancets | Nova Reusable Lancing Device and<br>Lancets…