K Number

Device Name

NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS

Manufacturer

NOVA BIOMEDICAL CORPORATION

Date Cleared

2012-03-09

(182 days)

Product Code

NBW JJX LFR

Regulation Number

862.1345

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. Nova Max One Glucose Test Strips are intended for use only with the Nova Max One Blood Glucose Monitor for quantitative tests. The Glucose Monitor is intended to quantitatively measure glucose (sugar) in fresh capillary whole blood obtained from the finger tip or alternative site testing (AST) on the forearm. AST can be used only during steady-state blood glucose conditions. The Glucose Monitor is calibrated to provide plasma equivalent results to laboratory methods. Nova Max One Glucose Test Strips are for testing outside the body (in vitro diagnostic use only). The Monitor should only be used by a single user in the home and should not be shared by users. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on newborns. Nova Max Control Solutions are intended for use with the Nova Max Blood 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).

Device Description

Nova Max One Blood Glucose Monitor The monitor is a hand-held testing device that works in conjunction with Nova Max 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 non-volatile format to prevent data loss. Nova Max One 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. 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 25 strips. Historical data (on file at Nova Biomedical) shows minimal differences between lots of test strips produced over 2 years. As a result, test strips will now be manufactured to meet a single calibration code requirement, allowing for the elimination of a calibration step for the user when using the Nova Max One Blood Glucose Monitor. 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 (1, 2 and 3). 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 market with the predicate Nova Max Blood Glucose Monitor System (K070255).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K070255, K051839, K092638

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard electrochemical glucose measurement technology and basic device functionality (data storage, user interface). There is no mention of AI/ML algorithms for data analysis, prediction, or interpretation.

Therapeutic

Explanation: The device is intended for quantitative measurement of glucose to aid in monitoring the effectiveness of diabetes control. It is explicitly stated that it is "not intended for the diagnosis of or screening for diabetes." Therefore, it is a diagnostic device used for monitoring rather than a therapeutic device that treats or prevents a condition.

Diagnostic

Yes

The device measures glucose levels in fresh capillary whole blood, which provides information to aid in monitoring the effectiveness of diabetes control. While it explicitly states it is "not intended for the diagnosis of or screening for diabetes," the measurement of glucose levels for monitoring purposes, particularly for a chronic condition like diabetes, falls under the umbrella of diagnostic or monitoring tools. It provides data that informs health management decisions, which is a key function of diagnostic devices, even if it's not for initial diagnosis.

SaMD (Software as a Medical Device)

The device description clearly outlines a "hand-held testing device" which is a hardware component, along with test strips and control solutions. This is not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states that the device is for "quantitative measurement of glucose in fresh capillary whole blood" and "for self testing outside the body". This clearly indicates testing of a biological sample (blood) outside of the body to obtain diagnostic information (glucose levels).
Device Description: The description of the test strips mentions a "reaction layer" and "glucose-enzyme" which are components involved in a chemical reaction with the blood sample to measure glucose. This is characteristic of in vitro diagnostic tests.
Control Solutions: The inclusion and description of control solutions for "quality control check to verify the accuracy of blood glucose test results" further supports its classification as an IVD. Control solutions are used to ensure the proper functioning and accuracy of in vitro diagnostic devices.
Explicit Statement: The description of the Nova Max One Glucose Test Strips explicitly states they are "for testing outside the body (in vitro diagnostic use only)".

All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Nova Max One Glucose Test Strips are intended for use only with the Nova Max One Blood Glucose Monitor for quantitative tests. The Glucose Monitor is intended to quantitatively measure glucose (sugar) in fresh capillary whole blood obtained from the finger tip or alternative site testing (AST) on the forearm. AST can be used only during steady-state blood glucose conditions. The Glucose Monitor is calibrated to provide plasma equivalent results to laboratory methods. Nova Max One Glucose Test Strips are for testing outside the body (in vitro diagnostic use only). The Monitor should only be used by a single user in the home and should not be shared by users. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on newborns.

Nova Max Control Solutions are intended for use with the Nova Max Blood 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).

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

NBW, LFR, JJX

Device Description

Nova Max One 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. 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 25 strips.
Historical data (on file at Nova Biomedical) shows minimal differences between lots of test strips produced over 2 years. As a result, test strips will now be manufactured to meet a single calibration code requirement, allowing for the elimination of a calibration step for the user when using the Nova Max One Blood Glucose Monitor.

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 (1, 2 and 3). 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 market with the predicate Nova Max Blood Glucose Monitor System (K070255).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

fingertip or alternative site testing (AST) on the forearm

Indicated Patient Age Range

The device is not intended for use on newborns.

Intended User / Care Setting

single-patient home use, self testing outside the body by people with diabetes mellitus

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 Max One Blood Glucose Monitor was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements.
Results of laboratory and clinical testing demonstrate that the performance of the Nova Max One Blood Glucose Monitor has the same intended uses, with similar technological characteristics and can produce 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.

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.

K070255, K051839, K092638

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

K112638

MAR - 9 2012

510(k) Summary

510(K) Owner:	Nova Biomedical Corporation
Registration
Number:	1219029
Address:	200 Prospect St.
Waltham, MA 02454 USA
Phone:	781-894-0800
Fax Number:	784-891-4806
Contact Person:	Paul W. MacDonald
Date Prepared:	12/19/2011
Proprietary Name:	Nova Max One Blood Glucose Monitoring System
Common Or Usual
Name:	Blood Glucose Monitor
Classification
Name:	System, Test, Blood Glucose, Over the Counter
Product Codes:	NBW, LFR, JJX
Predicate Device:	K070255 - Nova Max Blood Glucose Monitor System
K051839 - FreeStyle Freedom Blood Glucose Monitoring System
K092638 - FreeStyle Blood Glucose Test Strips
Device
Description:	Nova Max One Blood Glucose Monitor
The monitor is a hand-held testing device that works in conjunction with Nova Max
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 non-volatile format to prevent data
loss.
Nova Max One 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. 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 25 strips.
Historical data (on file at Nova Biomedical) shows minimal differences between lots
of test strips produced over 2 years. As a result, test strips will now be
manufactured to meet a single calibration code requirement, allowing for the
elimination of a calibration step for the user when using the Nova Max One Blood
Glucose Monitor.
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 (1, 2 and 3). 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 market with the predicate Nova Max Blood Glucose Monitor
System (K070255).
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.
Nova Max One Glucose Test Strips are intended for use only with the Nova Max
One Blood Glucose Monitor for quantitative tests. The Glucose Monitor is intended
to quantitatively measure glucose (sugar) in fresh capillary whole blood obtained
from the finger tip or alternative site testing (AST) on the forearm. AST can be used
only during steady-state blood glucose conditions. The Glucose Monitor is
calibrated to provide plasma equivalent results to laboratory methods. Nova Max
One Glucose Test Strips are for testing outside the body (in vitro diagnostic use
only). The Monitor should only be used by a single user in the home and should not
be shared by users. It is not intended for the diagnosis of or screening for diabetes,
and it is not intended for use on newborns.
Nova Max Control Solutions are intended for use with the Nova Max Blood 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).

، "،

| Summary of
Technological
Characteristics: | The Nova Max One Blood Glucose Monitor has the same fundamental scientific
technology and the same intended use as the current on-market Nova Max Blood
Glucose Monitor (K070255). The Nova Max One Blood Glucose Monitor is
substantially equivalent to the Nova Max Glucose Monitor System.
The Nova Max One Blood Glucose Monitor measures glucose electrochemically as
described in K070255 (Nova Max 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. |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to
Predicate Devices: | The Nova Max One Blood Glucose Monitor uses the same fundamental scientific
technology and has the same intended use as the predicate Nova Max Blood
Glucose Monitor (K070255). |
| Performance
Studies: | The performance of the Nova Max One Blood Glucose Monitor was studied in the
laboratory and in clinical settings by healthcare professionals and lay users. The
studies demonstrated that lay users can obtain blood glucose results that are
substantially equivalent to the current methods for blood glucose measurements. |
| Conclusion: | Results of laboratory and clinical testing demonstrate that the performance of the
Nova Max One Blood Glucose Monitor has the same intended uses, with similar
technological characteristics and can produce 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. |

: :

. . . . . . .

the was an a subscription of the subscription in the subscription in

Comparison of Predicate Devices and Proposed device

Characteristic	Measuring Range	Operating Principle	Intended Use	Characteristic	Hematocrit Range	Sample type	Sample size
Predicate
K070255 - Nova Max Blood
Glucose Monitor System	20-600 mg/dL	Coulometric Electro-chemical
Sensor	The Nova Max Blood Glucose
Monitor is intended to be used for
the quantitative measurement of
glucose in whole blood. It is
intended for use by people with
diabetes mellitus in the home as
an aid to monitor the effectiveness
of diabetes control. it is not
intended for use in the diagnosis
of or screening for diabetes
mellitus and is not intended for
use on neonates. The Nova Max
Blood Glucose Monitor is
specifically indicated for the
quantitative measurement of
glucose in whole blood samples
obtained from the fingertip,
forearm and palm.	Predicate
K070255 - Nova Max Blood
Glucose Monitor System	25% to 60%	Capillary blood: fingertip, forearm, palm	0.30 uL	mg/dL	Test strip capillary draw	Yes	Up to 400 blood glucose and
control solution tests	5 seconds	No	3 volt coin cell battery		Liquid	Glucose Oxidase	No User Input of Calibration code required
Predicate
K051839- Abbott FreeStyle
Freedom Blood Glucose
Monitoring System	20-500 mg/dL	Coulometric Electro-chemical
Sensor	The FreeStyle Freedom Blood
Glucose Monitoring System is
intended for use in the
quantitative measurement of
glucose in capillary whole
blood from the finger, upper
arm and palm, and venous
whole blood. It is intended for
use by healthcare
professionals and people with
diabetes mellitus at home as
an aid in monitoring the
effectiveness of a diabetes
control program. It is not
intended for the diagnosis of
or screening for diabetes
mellitus, and is not intended
for use on neonates or arterial
blood.	Predicate
K051839 – Abbott FreeStyle
Freedom Blood Glucose
Monitoring System	15% to 65%	Capillary blood: forearm,
upper arm, hand, thigh, calf,
or fingers	0.30 uL	mg/dL	Test strip capillary draw	Yes	Up to 400 blood glucose and
control solution tests	5 seconds	No	3 volt coin cell battery		Liquid	Glucose Dehydrogenase-
PQQ	No User Input of Calibration
coding required
Predicate
K092638 - Abbott FreeStyle
Blood Glucose Test Strips	20-500 mg/dL	Coulometric Electro-chemical
Sensor	The FreeStyle Lite Blood
Glucose Monitoring System is
intended for use in the
quantitative measurement of
glucose in capillary whole
blood from the finger, upper
arm and palm, and venous
whole blood. It is intended for
use by healthcare
professionals and people with
diabetes mellitus at home as
an aid in monitoring the
effectiveness of a diabetes
control program. It is not
intended for the diagnosis of
or screening for diabetes
mellitus, and is not intended
for use on neonates or
arterial blood.	Predicate
K092638 – Abbott FreeStyle
Blood Glucose Test Strips	15% to 65%	Capillary blood: forearm,
upper arm, hand, thigh, calf,
or fingers	0.30 uL	mg/dL	Test strip capillary draw	Yes	Up to 400 blood glucose and
control solution tests	4 seconds	No	3 volt coin cell battery		Liquid	Glucose Dehydrogenase -
FAD	Calibration coding required
Proposed
Nova Max One Blood Glucose
Monitor System	20-600 mg/dL	Coulometric Electro-chemical
Sensor	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	Proposed
Nova Max One Blood Glucose
Monitor System	25% to 60%	Capillary blood: fingertip,
forearm	0.40 uL	mg/dL	Test strip capillary draw	Yes	Up to 400 blood glucose and
control solution tests	4 seconds	No.	3 volt coin cell battery		Liquid	Glucose Dehydrogenase - FAD	No User Input of Calibration
code required

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Page 5 of 5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract representation of a human form or a bird in flight. The emblem is composed of several curved lines that create a sense of movement and dynamism.

10903 New Hampshire Avenue Silver Spring, MD 20993

Nova Biomedical Corporation c/o Paul W. MacDonald Chief Quality and Regulatory Affairs Officer 200 Prospect Street Waltham, MA 02454

MAR 0 9 2012

Re: K112638

Trade/Device Name: Nova Max One Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, LFR, JJX Dated: January 30, 2012 Received: February 1, 2012

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); lan the Ace oregallerinents, medical device reporting (reporting of medical device-related laberse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known): K112638

Device Name:

Nova Max One Blood Glucose Monitoring System

Indications for Use:

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 Diagnostic Devices (OIVD)

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

510(k) K112638

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