NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR by NOVA BIOMEDICAL CORPORATION

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 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 β-hydroxybutyrate 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).

Device Description

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).

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).

AI/ML Overview

Here's an analysis of the provided text regarding the Nova Max Mini Blood Glucose and ß-Ketone Monitor System, focusing on acceptance criteria and study details:

Missing Information/Limitations of Provided Text:

It's crucial to note that the provided 510(k) summary (K122688) for the Nova Max Mini Blood Glucose and ß-Ketone Monitor System does not contain the detailed performance study results that would directly state specific acceptance criteria and the device's performance against them, nor does it describe the methodology of these studies in detail (e.g., sample sizes for test sets, ground truth establishment, expert involvement, training set details).

The document primarily focuses on demonstrating substantial equivalence to predicate devices (K091547 and K112638) by highlighting similarities in technology, intended use, and operational principles. It states, "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." However, it does not provide the quantitative results from these "laboratory settings" studies.

Therefore, the following sections will be filled based on inferences from the general language of the document and common regulatory expectations for such devices, but direct evidence for most points is not present in the provided text.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Since specific quantitative acceptance criteria and detailed performance metrics are not explicitly stated in the provided 510(k) summary, this table is constructed based on the implied equivalence claims and common expectations for blood glucose and ketone monitoring systems. The "Reported Device Performance" is drawn from the summary's general statements about substantial equivalence.

Characteristic	Acceptance Criteria (Inferred/Typical for BGMS)*	Reported Device Performance (as per document)
Glucose Measurement
Accuracy	(e.g., within ±15 mg/dL or ±15% of reference for >95% of results, per ISO 15197)	"Glucose results that are substantially equivalent to the current methods."
Precision	(e.g., low CV%, repeatability)	Implied to be equivalent to predicate devices.
Measuring Range	20-600 mg/dL	20-600 mg/dL (Matched to predicate and proposed device specifications)
Hematocrit Range	25% to 60%	25% to 60% (Matched to predicate and proposed device specifications)
Sample Type	Capillary blood (fingertip, forearm)	Capillary blood from the fingertip or alternative site testing on the forearm.
Ketone Measurement
Accuracy	(e.g., within certain limits of reference method)	"Ketone results that are substantially equivalent to the current methods."
Precision	(e.g., low CV%, repeatability)	Implied to be equivalent to predicate devices.
Measuring Range	0.1 – 8.0 mmol/L	0.1 – 8.0 mmol/L (Matched to predicate and proposed device specifications)
Sample Type	Capillary blood (fingertip only)	Whole blood capillary samples obtained from the fingertip only.

Note: The acceptance criteria listed are inferred or typical for blood glucose monitoring systems based on ISO 15197 and FDA guidance; they are not explicitly stated in the provided K122688 document. The document primarily asserts substantial equivalence rather than presenting detailed validation data against specific criteria.

Study Details

As highlighted, the provided 510(k) summary does not contain detailed study information beyond general statements.

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

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: The document states "studied in the laboratory settings." This implies the data was collected under controlled laboratory conditions, likely in the country of manufacturing/submission (USA, given the 510(k) owner's address). The data would be prospective in nature, as it was generated to evaluate the performance of the new device.

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

Not applicable/Not specified. For in vitro diagnostic (IVD) devices like blood glucose and ketone monitors, ground truth is typically established using a reference laboratory method (e.g., YSI analyzer for glucose), not through expert consensus on qualitative assessment. The role of "experts" would be to perform the reference method and potentially collect samples. Their specific number or qualifications are not detailed.

4. Adjudication method for the test set:

Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., radiology image reading). For objective measurements from IVDs against a reference method, adjudication isn't typically part of the data analysis process itself, beyond ensuring correct operation of the reference assays.

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:

No. This is not relevant for an in vitro diagnostic (IVD) device like a blood glucose and ketone monitor. MRMC studies are typically performed for imaging devices or AI tools that assist human interpretation. This device provides a direct quantitative measurement.

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

Yes, this is a standalone device. Blood glucose and ketone monitors are inherently standalone devices that produce quantitative results directly. The "algorithm" is embedded in the device's software to process the electrochemical signal from the test strip. The performance studies would evaluate the accuracy and precision of the device (algorithm + hardware + strip) in producing these results without human interpretative intervention.

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

The ground truth would be established by a highly accurate and precise reference laboratory method for glucose and ß-ketone. For glucose, this often involves methods like hexokinase or glucose oxidase on a laboratory analyzer (e.g., YSI). For ß-ketone, a laboratory reference method would also be used.
- The document states: "...can provide glucose or ketone results that are substantially equivalent to the current methods for blood glucose and ketone measurements obtained from capillary blood." This implicitly refers to comparison against such reference methods.

8. The sample size for the training set:

Not applicable/Not specified. For electrochemical IVD devices like this, there isn't a "training set" in the machine learning sense. The device's calibration and algorithm are developed during the design phase using a range of samples as part of the product development and validation process, but it's not typically referred to as a "training set" in the same way as AI/ML models. The 510(k) summary focuses on the final validated performance.

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

Not applicable. As explained above, there isn't a "training set" in the typical AI/ML context for this type of IVD device. The ground truth for the development and validation of the device would be established using reference laboratory methods as described in point 7.

Summary

{0}------------------------------------------------

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: 781-894-0800 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

1. Classification:
  Class II (assay) and Class I, Reserved Controls
1. Product Codes:
  NBW, Blood Glucose Test System, Over-the-Counter

LFR, Glucose Dehydrogenase

JJY, Multi-Analyte Controls

JIN, Ketones

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

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

{1}------------------------------------------------

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 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.

ய Device Description:

Nova Max Mini Blood Glucose and ß-Ketone 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 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).

{2}------------------------------------------------

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.

{3}------------------------------------------------

Comparison of Predicate and Proposed device

Characteristic	Predicate - Nova Max One BloodGlucose Monitor System - K112638	Predicate – Nova Max Plus BloodGlucose and β-Ketone Monitor System -K091547	Proposed - Nova Max Mini BloodGlucose and β-Ketone Monitor System
Test Measured	Glucose	Glucose or β-Ketone	Glucose or β-Ketone
OperatingPrinciple	Coulometric Electro-chemical Sensor	Coulometric Electro-chemical Sensor	Coulometric Electro-chemical Sensor
Intended Use	The Nova Max One Blood GlucoseMonitor is intended to be used for thequantitative measurement of glucosein fresh capillary whole blood. It isintended for single-patient home useand should not be used for testingmultiple patients. It is intended forself testing outside the body bypeople with diabetes mellitus as anaid to monitor the effectiveness ofdiabetes control. The Nova Max OneBlood Glucose Monitor is specificallyindicated for the quantitativemeasurement of glucose in freshwhole blood capillary samplesobtained from the fingertip oralternative site testing (AST) on theforearm. AST on the forearm can beused only during steady-state bloodglucose conditions. It is not intendedfor the diagnosis of or screening fordiabetes, and it is not intended foruse on newborns.	The Nova Max Plus Glucose and β-Ketone Monitoring System is intended tobe used for the quantitative measurementof glucose or β-hydroxybutyrate (β-Ketone) in fresh capillary whole blood. Itis intended for use by people withdiabetes mellitus in the home and byhealthcare professionals in clinicalsettings as an aid to monitor theeffectiveness of diabetes control. It is notintended for use in the diagnosis of orscreening for diabetes mellitus and is notintended for use on neonates. The NovaMax Plus Monitor is specifically indicatedfor the quantitative measurement ofglucose in fresh capillary whole bloodsamples obtained from the fingertip,forearm, and palm or β-ketone in freshcapillary whole blood samples obtainedfrom the fingertip only.	The Nova Max Mini Blood Glucose and β-Ketone Monitor System is intended to beused for the quantitative measurement ofglucose or β-hydroxybutyrate (β-ketone)in fresh capillary whole blood. It isintended for single-patient home use andshould not be used for testing multiplepatients. It is intended for self-testingoutside the body by people with diabetesmellitus as an aid to monitor theeffectiveness of diabetes control. TheNova Max Mini Blood Glucose and β-Ketone Monitor System is specificallyindicated for the quantitativemeasurement of glucose in fresh capillarywhole blood obtained from the fingertip oralternative site testing on the forearm, orβ-ketone in whole blood capillary samplesobtained from the fingertip only. GlucoseAST on the forearm can be used onlyduring steady-state blood glucoseconditions.The Nova Max Mini is not intended for thediagnosis of or screening for diabetes,and it is not intended for use on neonates.
Characteristic	Predicate - Nova Max One BloodGlucose Monitor System - K112638	Predicate - Nova Max Plus BloodGlucose and β-Ketone Monitor System -K091547	Proposed - Nova Max Mini BloodGlucose and β-Ketone Monitor System
			The Nova Max Mini Blood Glucose TestStrips are intended for use only with theNova Max Mini Blood Glucose MonitorSystem to quantitatively measurecapillary blood glucose from the fingerand forearm.The Nova Max Mini Ketone Test Stripsare intended for use only on the NovaMax Mini Blood Glucose and β-KetoneMonitor System to quantitatively measurecapillary β-hydroxybutyrate from thefinger.Nova Max Mini Glucose/Ketone ControlSolutions are intended for use with theNova Max Mini Glucose and β-KetoneMonitor and test strips as a quality controlcheck to verify the accuracy of testresults. There are two levels of controls,(Level 2 and Level 3).
MeasuringRange	20-600 mg/dL	20-600 mg/dL	20-600 mg/dL
KET MeasuringRange	N/A	0.1 – 8.0 mmol/L	0.1 - 8.0 mmol/L
HematocritRange	25% to 60%	25% to 60%	25% to 60%
Sample type	Capillary blood from the fingertip,forearm	Capillary blood from the fingertip, forearmand palm (Ketone fingertip only)	Capillary blood from the fingertip, forearm(Ketone fingertip only)
GLU Sample	0.4 µL	0.3 µL	0.4 µL
Characteristic	Predicate - Nova Max One BloodGlucose Monitor System - K112638	Predicate – Nova Max Plus BloodGlucose and β-Ketone Monitor System –K091547	Proposed - Nova Max Mini BloodGlucose and β-Ketone Monitor System
Glucose Units	mg/dL	mg/dL	mg/dL
Ketone Units	N/A	mmol/L	mmol/L
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 controlsolution tests	Up to 400 blood glucose and controlsolution tests	Up to 400 blood glucose and controlsolution tests
GLU AnalysisTime	4 seconds	5 seconds	4 seconds
Insulin Tracking	No.	No	No.
KET AnalysisTime	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 StripsActive reagent:	Glucose, Dehydrogenase - FAD	Glucose Oxidase	Glucose Dehydrogenase - FAD
KET Test StripsActive reagent	N/A	β-hydroxybutyrate dehydrogenase	β-hydroxybutyrate dehydrogenase
Test StripCalibrationCoding	No User Input of Calibration coderequired	No User Input of Calibration coderequired	No User Input of Calibration coderequired
Lancing Device:	Nova Reusable Lancing Device andLancets	Nova Reusable Lancing Device andLancets	Nova Reusable Lancing Device andLancets

{4}------------------------------------------------

and the control control control control controllers and

{5}------------------------------------------------

and the comments of the comments of the country

and the comments of the country of

100 come of the comments of

. . .

{6}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

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

April 4, 2013

Nova Biomedical Corporation c/o Paul MacDonald, Ph.D. . 200 Prospect Street WALTHAM MA 02454

Re: K122688

Trade/Device Name: Nova Max Mini Blood Glucose and ß-ketone Monitor System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJY, JIN Dated: March 22, 2013 Received: March 25, 2013

Dear Dr. 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, 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 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.

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

{7}------------------------------------------------

Page 2-Mr. MacDonald

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.hum.

Sincerely yours,

Carol C. Benson -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

{8}------------------------------------------------

Indications for Use Form

510(k) Number (if known): K122688

Device Name:

Nova Max Mini Blood Glucose and ß-Ketone Monitor System

Indications for Use:

The Nova Max Mini Blood Glucose and ß-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 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 ßketone 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 Ketone Test Strips are intended for use only on the Nova Max Mini Blood Glucose and ß-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).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use __ × (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 Devices and Radiologic Health (OIR)

Kathering / Serrano

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k)_k122688

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.