(422 days)
Not Found
No
The device description and performance studies focus on electrochemical biosensor technology and standard accuracy/precision metrics. There is no mention of AI, ML, or related concepts.
No
The device is an in vitro diagnostic device used to measure blood ketone levels, which aids in monitoring the effectiveness of a diabetes control program. It does not provide treatment or directly alleviate a medical condition, which are characteristic functions of a therapeutic device.
Yes
The device is explicitly stated to be for "quantitative measurement of ß-Ketone (beta-hydroxybutyrate) level" and for "in vitro diagnostic use," which are characteristic functions of diagnostic devices. It is also described as an "aid to monitor the effectiveness of diabetes control program," which implies a diagnostic or monitoring role.
No
The device description explicitly states that the system consists of a meter, single-use test strips, and control solutions, which are all hardware components. The system is based on electrochemical biosensor technology, which also involves hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for both the KetoSens Blood ß-Ketone Monitoring System and the KetoSens Multi Blood ß-Ketone Monitoring System explicitly states they are "for in vitro diagnostic use".
- Measurement of Analyte in Biological Sample: The device is intended for the "quantitative measurement of ß-Ketone (beta-hydroxybutyrate) level in capillary whole blood samples" and "venous EDTA whole blood". This involves analyzing a biological sample outside of the body.
- Aid to Monitor a Medical Condition: The intended use is "as an aid to monitor the effectiveness of diabetes control program". This indicates the results are used to inform decisions related to a medical condition.
- Testing Outside the Body: The description mentions "self-testing outside the body" and the analysis of blood samples, which are performed externally.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
KetoSens Blood ß-Ketone Monitoring System is intended to be used for the quantitative measurement of f-Ketone (beta-hydroxybutyrate) level in capillary whole blood samples drawn from the fingertip. The KetoSens Blood B-Ketone Monitoring Systems are for self-testing outside the body (for in vitro diagnostic use) in the home as an aid to monitor the effectiveness of diabetes control program. The system is not in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared.
The KetoSens Blood ß-Ketone Test Strips work with the KetoSens Blood ß-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the fingertip.
KetoSens Multi Blood p-Ketone Monitoring System is intended to be used for the quantitative measurement of f-Ketone (beta-hydroxybutyrate) level in capillary whole blood from the fingertip and venous EDTA whole blood. KetoSens Multi Blood ß-Ketone Monitoring System is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system should only be used with single-use, auto-disabling lancing devices.
The KetoSens Multi Blood p-Ketone Test Strips work with Blood ß-Ketone Meter to quantitatively measure Blood B-Ketone in capillary whole blood samples drawn from the fingertip and venous whole blood drawn in professional healthcare settings.
Product codes (comma separated list FDA assigned to the subject device)
JIN
Device Description
The KetoSens Blood ß-Ketone Monitoring System/KetoSens Multi Blood ß-Ketone Monitoring System consists of a meter, single use test strips, and control solutions with two different B-Ketone concentrations ("Control A" and "Control B" ranges).
The KetoSens Blood ß-Ketone Monitoring System/KetoSens Multi Blood ß-Ketone Monitoring System is based on an electrochemical biosensor technology (electrochemical). The System measures the Blood ß-Ketone level in whole blood samples using a small electrical current generated in the test strips.
The following items are included in the KetoSens Blood ß-Ketone Monitoring System:
- 1 KetoSens Blood ß-Ketone Meter
- 1 Lancing device
- 10 Lancets
- Carrying Case
- 1 Owner's Booklet
- 1 Quick Reference Guide
- 2 Batteries (3.0V lithium batteries)
The following items are included in the KetoSens Multi Blood ß-Ketone Monitoring System:
- KetoSens Multi Blood ß-Ketone Meter
- 1 Owner's Booklet
- 2 Batteries (3.0V lithium batteries)
- Carrying Case
The following items is compatible with the KetoSens Blood ß-Ketone Monitoring System and KetoSens Multi Blood ß-Ketone Monitoring System and is available separately.
- KetoSens (Multi) Blood ß-Ketone Test Strips
- The KetoSens ß-Ketone Control Solution (Level A and B)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, blood (capillary whole blood, venous EDTA whole blood)
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
KetoSens Blood ß-Ketone Monitoring System: self-testing, home, single person use.
KetoSens Multi Blood ß-Ketone Monitoring System: multiple-patient use, professional healthcare settings.
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)
- Repeatability Test (Report No. BKM-031F-R001):
- Purpose: to confirm the precision of Ketone Monitoring System through evaluating test results of blood samples obtained by the same user using multiple meters and strip lots.
- Sample Size: 300 measurements for each concentration level.
- Key results: The pooled SD of concentration intervals 1, 2 were 0.027, 0.056mmo/L respectively that were below 0.075 mmo/L. The pooled CV % of concentration intervals 3, 4 and 5 were 3.7, 3.5 and 3.6%, respectively that were below 5.0 %.
- Intermediate Precision Test (Report No. BKM-031F-R002):
- Purpose: to evaluate the test dates, other uses, and results tested with other meters in a similar environment using KetoSens Blood {}-Ketone Monitoring System (BKMS) and control solution.
- Sample Size: 600 measurements for each control level.
- Key results: The pooled SD for concentration interval 1 was 0.049mmol/L that is less than 0.075mmol/L, and the pooled CV for interval 2, 3 were 3.8, 4.3, respectively that are below 5.0 %.
- Linearity Test (Report No. BKM-031F-R003):
- Purpose: to demonstration range (from 0 mmol/L to 8.0 mmo/L) of KetoSens Blood f-Ketone Monitoring System and confirm linearity through Linearity Study.
- Key results: The coefficient of determination (x2) was able to confirm a high linear correlation above 0.95 for all strip lots and total strip lots (r2 values range from 0.9982 to 0.9987).
- System Accuracy Test (Report No. BKM-031F-R004):
- Purpose: to conducting system accuracy of KetoSens Blood Ketone Monitoring System (BKMS) through clinical evaluation using capillary and venous blood samples.
- Sample Size: minimum of 200 capillary blood samples, 204 capillary blood samples, 204 venous blood samples.
- Key results (Capillary blood): 100 % of 204 capillary blood samples fell within either = 0.3 mmol/L of the reference measurement procedure at ketone concentrations
§ 862.1435 Ketones (nonquantitative) test system.
(a)
Identification. A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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April 13, 2018
i-SENS, Inc. Joon Ho Jung RA Team Manager 43, Banpo-daero 28-gil, Seocho-gu Seoul, 06646 Korea
Re: K170463
Trade/Device Name: KetoSens Blood β-Ketone Monitoring System KetoSens Multi Blood ß-Ketone Monitoring System Regulation Number: 21 CFR 862.1435 Regulation Name: Ketones (nonquantitative) test system C Regulatory Class: Class I, meets limitation of exemptions 21 CFR 862.9(c)(5) Product Code: JIN Dated: April 3, 2018 Received: April 10, 2018
Dear Joon Ho Jung:
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
1
801 and Part 809); medical device 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kellie B. Kelm -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
2
Indications for Use
510(k) Number (if known) K170463
Device Name KetoSens Blood ß-Ketone Monitoring System
Indications for Use (Describe)
KetoSens Blood ß-Ketone Monitoring System is intended to be used for the quantitative measurement of f-Ketone (betahydroxybutyrate) level in capillary whole blood samples drawn from the fingertip. The KetoSens Blood B-Ketone Monitoring Systems are for self-testing outside the body (for in vitro diagnostic use) in the home as an aid to monitor the effectiveness of diabetes control program. The system is not in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared.
The KetoSens Blood ß-Ketone Test Strips work with the KetoSens Blood ß-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the fingertip.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K170463
Device Name
KetoSens Multi Blood ß-Ketone Monitoring System
Indications for Use (Describe)
KetoSens Multi Blood p-Ketone Monitoring System is intended to be used for the quantitative measurement of f-Ketone (beta-hydroxybutyrate) level in capillary whole blood from the fingertip and venous EDTA whole blood. KetoSens Multi Blood ß-Ketone Monitoring System is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system should only be used with single-use, auto-disabling lancing devices.
The KetoSens Multi Blood p-Ketone Test Strips work with Blood ß-Ketone Meter to quantitatively measure Blood B-Ketone in capillary whole blood samples drawn from the fingertip and venous whole blood drawn in professional healthcare settings.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the logo for i-sens. The logo consists of the letter "i" in blue, with a green circle above it. The word "sens" is written in blue next to the "i". The logo is simple and modern.
510(k) Summary
Introduction 1.
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
| 1.1 | Type of 510(k): | Traditional 510(k) |
|---|---|---|
| 1.2 | Submitter Information: | i-SENS, Inc. |
| 43, Banpo-daero 28-gil, Seocho-gu, Seoul, Korea | ||
| Tel.) +82-2-910-0453 | ||
| Fax) +82-2-942-2514 | ||
| e-mail: jhjung@i-sens.com | ||
| Contact Person: Joon Ho Jung | ||
| 1.3 | Prepared Date: | April 3, 2018 |
2. Device Name
| 2.1 Trade Name | KetoSens Blood β-Ketone Monitoring System |
|---|---|
| KetoSens Multi Blood β-Ketone Monitoring System | |
| 2.2 Classification Name | JIN - Class I, 21 CFR 862.1435 Ketones (nonquantitative) test system |
| Meets limitations of exemptions 21 CFR 862.9(c)(5) | |
| 2.3 510k Number | K170463 |
KetoSens Blood B-Ketone Monitoring System and KetoSens Multi Blood B-Ketone Monitoring System are essentially the same product in exception to the product name. The two systems include the same meter, test strips, and control solution with the only difference in the names due to the different indications for use (single vs. multiple-patient use). Due to the nature of the similarities, the candidate device's name of KetoSens Blood ß-Ketone Monitoring System will be used as a representative of the two devices in this submission.
Device Description 3.
The KetoSens Blood ß-Ketone Monitoring System/KetoSens Multi Blood ß-Ketone Monitoring System consists of a meter, single use test strips, and control solutions with two different B-Ketone concentrations ("Control A" and "Control B" ranges).
The KetoSens Blood ß-Ketone Monitoring System/KetoSens Multi Blood ß-Ketone Monitoring System is based on an electrochemical biosensor technology (electrochemical). The System measures the Blood ß-Ketone level in whole blood samples using a small electrical current generated in the test strips.
5
The following items are included in the KetoSens Blood ß-Ketone Monitoring System:
- 1 KetoSens Blood ß-Ketone Meter
- 1 Lancing device
- 10 Lancets
- Carrying Case
- 1 Owner's Booklet
- 1 Quick Reference Guide
- 2 Batteries (3.0V lithium batteries)
The following items are included in the KetoSens Multi Blood ß-Ketone Monitoring System:
- KetoSens Multi Blood ß-Ketone Meter
- 1 Owner's Booklet
- 2 Batteries (3.0V lithium batteries)
- Carrying Case
The following items is compatible with the KetoSens Blood ß-Ketone Monitoring System and KetoSens Multi Blood ß-Ketone Monitoring System and is available separately.
- KetoSens (Multi) Blood ß-Ketone Test Strips -
- The KetoSens ß-Ketone Control Solution (Level A and B)
Intended Use 4.
4.1 KetoSens Blood ß-Ketone Monitoring System
KetoSens Blood ß-Ketone Monitoring System is intended to be used for the quantitative measurement of {}-Ketone (beta-hydroxybutyrate) level in capillary whole blood samples drawn from the fingertip. The KetoSens Blood ß-Ketone Monitoring Systems are for self-testing outside the body (for in vitro diagnostic use) in the home as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared.
The KetoSens Blood ß-Ketone Test Strips work with the KetoSens Blood ß-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the fingertip.
6
KetoSens Multi Blood ß-Ketone Monitoring System 4.2
KetoSens Multi Blood ß-Ketone Monitoring System is intended to be used for the quantitative measurement of ß-Ketone (beta-hydroxybutyrate) level in capillary whole blood from the fingertip and venous EDTA whole blood. KetoSens Multi Blood ß-Ketone Monitoring System is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system should only be used with singleuse, auto-disabling lancing devices.
The KetoSens Multi Blood ß-Ketone Test Strips work with the KetoSens Multi Blood ß-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the fingertip and venous whole blood drawn in professional healthcare settings.
Substantial Equivalence Information 5.
The candidate devices are comparable and substantially equivalent to the predicate device.
- 5.1 Predicate Device Name Nova Max Plus Blood Glucose and ß-Ketone Monitoring System Nova Max Blood Glucose and ß-Ketone Monitor -The Nova Max Plus Ketone Test Strips -
- K091547 Predicate 510(k) Number 3.2
6. Comparison with Predicate Devices
Table 1. The Composition Comparison of the Candidate Devices with the Predicate device
| Device Name | Nova Max Plus Blood Glucose and
β-Ketone Monitoring System
( Predicate device ) | KetoSens Blood β-Ketone
Monitoring System
( Candidate device ) |
|-------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Meter | Image: Nova Max Plus Blood Glucose Meter | Image: KetoSens Blood β-Ketone Monitoring System |
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43, Banpo-daero 28-gil, Seocho-gu, Seoul, Korea
43, Banpo-daero 28-gil, Seocho-gu, Seoul, Korea
Tel: +82-2-916-6191 Fax: +82-2-942-2514
| Device Name | Nova Max Plus Blood Glucose and
β-Ketone Monitoring System | KetoSens Blood β-Ketone
Monitoring System |
|-------------|------------------------------------------------------------------------------|-------------------------------------------------------------|
| | (Predicate device) | (Candidate device) |
| Test Strips | Image: Nova Max Plus Blood Glucose and β-Ketone Monitoring System Test Strip | Image: KetoSens Blood β-Ketone Monitoring System Test Strip |
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Image /page/8/Picture/0 description: The image shows the logo for i-sens. The logo is blue, except for a green dot above the "i". The text is sans-serif and bolded.
6.1 Similarities and Differences
The candidate device and the predicate device (Ketone) are classified under 21 CFR 862.1435, which states: "A ketones (nonquantitative) est system is a device intended to identify ketones in urine and other body fluids. Identification of ketones and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on kets and patients with diabetes." The predicate device has the capacity to measure both glucose as well as {}- ketone in blood, whereas the can'y measures }- ketone. Substantial equivalence is claimed for the ketone measurement parameter of the predicate device since the of the devices are identical in terms of measuring ketone, and the indications only differ in glucose measuring capabilities between the candidate device and the predicate device.
The intended use for Ketone, operating principle, fundamental scientific technology of the candidate device. The list of similarities and differences between the candidate device and the predicate device are shown in Table 2:
| Item | Nova Max Plus Blood Glucose and
β-Ketone Monitoring System
(Predicate device) | KetoSens Blood β-Ketone Monitoring System
(Candidate device) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Nova Max Plus Blood Glucose and β-Ketone
Monitoring System Monitor is intended to be used for the
quantitative measurement of glucose 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 Blood
Glucose and β-Ketone Monitor is specifically indicated
for the quantitative measurement of glucose in fresh
capillary whole blood samples obtained from the
fingertip, forearm and palm and β-hydroxybutyrate (β-
ketone) in capillary whole blood from the finger only. | Single-patient use
KetoSens Blood β-Ketone Monitoring System is intended to be
used for the quantitative measurement of β-Ketone (beta-
hydroxybutyrate) level in capillary whole blood samples drawn
from the fingertip. The KetoSens Blood β-Ketone Monitoring
Systems are for self-testing outside the body (for in vitro
diagnostic use) in the home as an aid to monitor the
effectiveness of diabetes control program. The system is not
intended for use in the diagnosis of or screening for diabetes
mellitus and is not intended for use on neonates. This system is
intended to be used by a single person and should not be shared.
The KetoSens Blood β-Ketone Test Strips work with the
KetoSens Blood β-Ketone Meter to quantitatively measure
Blood β-Ketone in capillary whole blood samples drawn from
the fingertip. |
| | The Nova Max Plus Ketone Test Strips are intended for
use only on the Nova Max Plus Blood Glucose and β-
Ketone Monitor.
Nova Max Plus Ketone Control Solutions are intended for
use with Nova Max Plus Blood Glucose and β-Ketone
Monitor and Nova Max β-Ketone Test Strips as a quality
control check to verify the accuracy of blood ketone test
results. There are three levels of controls, (Levels 1,2 and
3). | The KetoSens β-Ketone Control Solutions are intended for use
with the KetoSens Blood β-Ketone meter and KetoSens Blood
β-Ketone test strip to check that the meter and the test strip are
working together properly and that the test is performing
correctly.
Multiple-patient use
KetoSens Multi Blood β-Ketone Monitoring System is intended
to be used for the quantitative measurement of β-Ketone (beta-
hydroxybutyrate) level in capillary whole blood from the
fingertip and venous EDTA whole blood. KetoSens Multi Blood
β-Ketone Monitoring System is intended for in vitro diagnostic
use and is intended for multiple-patient use in professional
healthcare settings as an aid to monitor the effectiveness of
diabetes control program. The system is not intended for use
in the diagnosis of or screening for diabetes mellitus and is not
intended for use on neonates. This system should only be used
with single-use, auto-disabling lancing devices. |
| | | The KetoSens Multi Blood β-Ketone Test Strips work with the
KetoSens Multi Blood β-Ketone Meter to quantitatively
measure Blood β-Ketone in capillary whole blood samples
drawn from the fingertip and venous whole blood drawn in
professional healthcare settings. |
| | | The KetoSens β-Ketone Control Solutions are intended for use
with the KetoSens Multi Blood β-Ketone meter and KetoSens
Multi Blood β-Ketone test strip to check that the meter and the
test strip are working together properly and that the test is
performing correctly. |
| Fundamental scientific technology | | |
| Operating principle | β-hydroxybutyrate (β- ketone) is converted by β-
hydroxybutyrate dehydrogenase and the magnitude of | Same |
Table 2. The Similarities and Differences between the Candidate Devices and the Predicate Device
9
i·sens
i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu, Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514
| Page 6 of 18 |
|---|
10
| electrical current resulting from this enzymatic reaction | ||
|---|---|---|
| is proportional to the amount of β-hydroxybutyrate | ||
| present in the sample. | ||
| Assay method | Electrochemical | Same |
| Active reagent | β-hydroxybutyrate dehydrogenase | Same |
| Test measured | Blood Glucose and β-Ketone | Blood β-Ketone |
| Technical specifications | ||
| Sample type | Fresh capillary whole blood (fingertip) | Fresh capillary whole blood (fingertip) |
| Venous EDTA whole blood (multi-patient use only) | ||
| Hematocrit range | 25%-60% | 20%-55% |
| Operating | ||
| Temperature Range | 59°F - 86°F | 50 °F ~ 104 °F |
| Operating Relative | ||
| Humidity | 10%- 90% RH | Same |
| Test time (sec.) | 10 | 8 |
| Memory capacity | Up to 400 | Up to 1,000 |
| Power source | 3 volt coin cell battery CL 2450 | Two 3.0 V lithium batteries (CR2032) |
| Weight | 2.65 oz | 2.53 oz (with batteries) |
| Test range | 0.1 - 8.0 mmol/L | Same |
| Controls | Nova Max Max Plus Ketone Control Solutions | |
| (Levels 1, 2, and 3) | KetoSens β-Ketone Control Solutions | |
| (Level A and B) | ||
| Coding | No User Input required for Nova Max | No coding required (Automatic code identification) |
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Image /page/11/Picture/0 description: The image shows the logo for i-sens. The "i" is green and the rest of the word is blue. The logo is simple and modern.
7. Risk Analysis
We have performed a risk analysis to confirm that risks determined from Preliminary Risk Analysis and severty and to show detailed countermeasures information, warning, indication and design. Based on risk analysis results, we've conducted the performance evaluation tests to confirm the safety and effectiveness of the candidate device.
Validation Activity Summary for the Candidate Device 8.
We have conducted the following validation tests to confirm that the candidate device works properly. Table 4 is the summary of the software validation test results for the candidate device. The tests were conducted for Ketone Monitoring System software.
| Test ID and name | Validation activities descriptions | Test results summary |
|---|---|---|
| MR16-014_3~06 | ||
| Performance Test (Drop, | ||
| Vibration, Temperature and | ||
| Humidity exposure limits tests) | Test the performance of meter by | |
| dropping, vibrating, and exposing to high | ||
| or low temperature and high humidity. | ||
| After the test, check the measurement and | ||
| operation performance. | Measurement and operation performance of | |
| all meters passed the tests. | ||
| BKM-031F-R021-3 | ||
| Software Function Test | Test the performance of meter based on set | |
| criteria. | 100% Compliance | |
| BKM-031F-R022-3 | ||
| Memory Test Report | 1st Test is to confirm if the meter operates | |
| correctly in full occupied memory | ||
| condition. | ||
| 2nd Test is to confirm if the memory | ||
| records and recalls the measured data and | ||
| calculates average data correctly. 3rd Test | ||
| is to confirm if the meter calculates | ||
| average value on leap year correctly. | Average calculated by meter software | |
| exactly matched with average calculated | ||
| manually. | ||
| BKM-031F-R023-3 | To check if the clock is running | |
| accurately for a period of time | It is confirmed that the time differential | |
| between the meter and international |
Table 3. Software Validation Summary
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| Test ID and name | Validation activities descriptions | Test results summary |
|---|---|---|
| Time Test Report | standard time is within ±15 sec. Therefore, Time function of the meter has been verified. | |
| BKM-031F-R024-3 | ||
| DAC Function Test Report | To verify that the reference voltage of the work electrode is 200 mV. | Test result shows that DAC function of the meter has been verified through 10 meters. Therefore, DAC function of the meter has been verified. |
| BKM-031F-R025-3 | ||
| Measurement Timing and ADC | ||
| Test Report | To verify if the Measurement timing and ADC function works correctly corresponding to the requirement specification. | Test results confirmed that Measurment timing and ADC function of KetoSens has been verified. |
| BKM-031F-R026-3 | ||
| Code Identification Test Report | To verify the automatic code identification (no coding) function of the meter works properly. | Test result shows that code #1~15 have been correctly identified by all meters. |
| BKM-031F-R027-3 | ||
| Power Consumption Test Report | To verify the power consumption in various modes of the meter works properly. | Test result confirmed that the meter has been verified through 10 meters. |
| BKM-031F-R028-3 | ||
| Battery Lifetime Test Report | To verify capable testing times on a continuous measurement condition. | Estimation of the number of times it is capable of testing based on the electrical current consumption and it is possible test about 7320 times. The actual measurement testing was conducted with 2EA the samples. It is assured that the model is capable of testing 3000 times. |
Performance Evaluation Summary of the Candidate Device 9.
9.1 Repeatability Test (Report No. BKM-031F-R001)
The purpose of repeatability test is to confirm the precision of Ketone Monitoring System through evaluating test results of blood
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Image /page/13/Picture/0 description: The image shows the logo for i-sens. The "i" is lowercase and has a green dot above it. The rest of the word, "sens", is also lowercase and in blue. The logo is simple and modern.
samples obtained by the same user using multiple meters and strip lots.
| Concentration
(mmol/L) | N | Mean
(mmol/L) | SD
(mmol/L) | %CV |
|---------------------------|-----|------------------|----------------|-----|
| 0.4 | 300 | 0.39 | 0.027 | 6.8 |
| 1.1 | 300 | 1.08 | 0.056 | 5.1 |
| 3.4 | 300 | 3.38 | 0.126 | 3.7 |
| 5.2 | 300 | 5.16 | 0.182 | 3.5 |
| 6.9 | 300 | 6.91 | 0.248 | 3.6 |
Summary results of repeatability test for the KetoSens Blood β-Ketone Monitoring System
Conclusion:
The pooled SD of concentration intervals 1, 2 were 0.027, 0.056mmo/L respectively that were below 0.075 mmo/L. The pooled CV % of concentration intervals 3, 4 and 5 were 3.7, 3.5 and 3.6%, respectively that were below 5.0 %.
Intermediate Precision Test (Report No. BKM-031F-R002) 9.2
The purpose of this intermediate precision test is to evaluate the test dates, other uses, and results tested with other meters in a similar environment using KetoSens Blood {}-Ketone Monitoring System (BKMS) and control solution.
Organized results for each lot and results summed up
| Control
Level | N | Mean
(mmol/L) | SD
(mmol/L) | %CV |
|------------------|-----|------------------|----------------|-----|
| Level 1 | 600 | 0.63 | 0.049 | 7.7 |
| Level 2 | 600 | 2.23 | 0.085 | 3.8 |
| Level 3 | 600 | 4.04 | 0.173 | 4.3 |
| Page 10 of 18 |
|---|
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Conclusion:
The pooled SD for concentration interval 1 was 0.049mmol/L that is less than 0.075mmol/L, and the pooled CV for interval 2, 3 were 3.8, 4.3, respectively that are below 5.0 %.
Linearity Test (Report No. BKM-031F-R003) 9.3
The purpose of conducting linearity test is to demonstration range (from 0 mmol/L to 8.0 mmo/L) of KetoSens Blood f-Ketone Monitoring System and confirm linearity through Linearity Study.
Table 3. Summary results of Linearity test
Strip lot. ML07KEA05B : y = 1.0034x - 0.0145, r2 = 0.9987 Strip lot. ML07KEA10C : y = 1.0250x - 0.0466, r2 = 0.9982 Strip lot. ML08KEA07B : y = 1.0209x - 0.0323, r2 = 0.9982 Total 3 strip lots: y = 1.0159x -0.0303, r2 = 0.9985
Conclusion:
Linearity test was conducted by measuring the ketone level in the whole blood samples usings. These results were able to obtain the following linear equation and the coefficient of determination (x2) was able to confirm a high linear correlation above 0.95.
System Accuracy Test (Report No. BKM-031F-R004) 9.4
The purpose of conducting system accuracy of KetoSens Blood Ketone Monitoring System (BKMS) through clinical evaluation using capillary and venous blood samples. The acuracy of KetoSens is evaluated with capillary blood samples collected from a minimum of 200 sample is evaluated with each of strip lots on one meters run with the KetoSens BKMS and with the standard measurement.
| Item | Result | ||
|---|---|---|---|
| ketone | |||
| concentration |