(212 days)
No
The device description and intended use focus on electrochemical measurement of glucose and ketones using test strips and a monitor. There is no mention of AI or ML in the text.
No.
The device is intended for quantitative measurement and monitoring of glucose or ß-ketone levels, which aids in monitoring the effectiveness of diabetes control, but it does not directly treat or cure the condition.
No
The device is intended for "monitoring the effectiveness of diabetes control" and not for the "diagnosis of or screening for diabetes."
No
The device description clearly outlines a hand-held testing device (hardware) that works in conjunction with test strips (hardware/consumable) to measure glucose or ketones. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is for the "quantitative measurement of glucose or ß-hydroxybutyrate (ß-ketone) in fresh capillary whole blood." This involves testing a biological sample (blood) outside the body to obtain diagnostic information (glucose and ketone levels).
- Device Description: The description details how the device works with test strips to measure these substances in a blood sample.
- Components: The system includes test strips and control solutions, which are typical components of IVD devices used for chemical analysis of biological samples.
- Regulatory Context: The mention of predicate devices with K numbers (K091547 and K112638) indicates that this device has gone through the FDA's regulatory process for medical devices, specifically those used for in vitro diagnostics.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, tissue, or urine, that have been taken from the human body to help detect, diagnose, monitor, or treat disease. This device clearly fits that definition.
N/A
Intended Use / 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 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 ß-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).
Product codes
NBW, LFR, JJY, JIN
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 ß-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 ß-Ketone test strips contain a reaction layer that contains the enzyme ßhydroxybutyrate 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 ß-Ketone Control Solution (K101633).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip, Forearm (for Glucose), Fingertip (for ß-ketone)
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
Single-patient home use for self-testing.
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 Mini Blood Glucose and ß-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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
-
- Classification:
Class II (assay) and Class I, Reserved Controls
- Classification:
-
- Product Codes:
NBW, Blood Glucose Test System, Over-the-Counter
- Product Codes:
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 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).
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 Blood
Glucose Monitor System - K112638 | Predicate – Nova Max Plus Blood
Glucose and β-Ketone Monitor System -
K091547 | Proposed - Nova Max Mini Blood
Glucose and β-Ketone Monitor System |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Measured | Glucose | Glucose or β-Ketone | Glucose or β-Ketone |
| Operating
Principle | Coulometric Electro-chemical Sensor | Coulometric 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 Nova Max Plus Glucose and β-
Ketone Monitoring 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 use by people with
diabetes mellitus in the home and by
healthcare professionals in clinical
settings 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 Plus Monitor is specifically indicated
for the quantitative measurement of
glucose in fresh capillary whole blood
samples obtained from the fingertip,
forearm, and palm or β-ketone in fresh
capillary whole blood samples obtained
from the fingertip only. | 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. |
| Characteristic | Predicate - Nova Max One Blood
Glucose Monitor System - K112638 | Predicate - Nova Max Plus Blood
Glucose and β-Ketone Monitor System -
K091547 | Proposed - Nova Max Mini Blood
Glucose and β-Ketone Monitor System |
| | | | 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
Nova Max Mini Glucose and β-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). |
| Measuring
Range | 20-600 mg/dL | 20-600 mg/dL | 20-600 mg/dL |
| KET Measuring
Range | N/A | 0.1 – 8.0 mmol/L | 0.1 - 8.0 mmol/L |
| Hematocrit
Range | 25% to 60% | 25% to 60% | 25% to 60% |
| Sample type | Capillary blood from the fingertip,
forearm | Capillary blood from the fingertip, forearm
and 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 Blood
Glucose Monitor System - K112638 | Predicate – Nova Max Plus Blood
Glucose and β-Ketone Monitor System –
K091547 | Proposed - Nova Max Mini Blood
Glucose and β-Ketone Monitor System |
| Glucose Units | mg/dL | mg/dL | mg/dL |
| Ketone Units | N/A | mmol/L | mmol/L |
| Sample
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
solution tests | Up to 400 blood glucose and control
solution tests | Up to 400 blood glucose and control
solution tests |
| GLU Analysis
Time | 4 seconds | 5 seconds | 4 seconds |
| Insulin Tracking | No. | No | No. |
| KET Analysis
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
Active reagent: | Glucose, Dehydrogenase - FAD | Glucose Oxidase | Glucose Dehydrogenase - FAD |
| KET Test Strips
Active reagent | N/A | β-hydroxybutyrate dehydrogenase | β-hydroxybutyrate dehydrogenase |
| Test Strip
Calibration
Coding | No User Input of Calibration code
required | No User Input of Calibration code
required | No User Input of Calibration code
required |
| Lancing Device: | Nova Reusable Lancing Device and
Lancets | Nova Reusable Lancing Device and
Lancets | Nova Reusable Lancing Device and
Lancets |
.
4
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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 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 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
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