(98 days)
Not Found
No
The description focuses on electrochemical biosensor technology for glucose measurement and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is an in vitro diagnostic device used to monitor glucose levels, not to treat a medical condition.
No
The "Intended Use" section explicitly states, "It is not intended for use on neonates and is not for the diagnosis or screening of diabetes." The system is for "monitoring the effectiveness of diabetes control," which implies managing an already diagnosed condition, not diagnosing it.
No
The device description explicitly states the system consists of a multi-use blood glucose meter, test strips, and control solutions, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The system is intended for use outside the body (in vitro diagnostic use)..."
N/A
Intended Use / Indications for Use
The Assure® Prism multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites (forearm, palm, thigh, and calf). Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for use outside the body (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. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
Assure® Prism multi Blood Glucose Test Strips are for use with the Assure® Prism multi blood glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
Product codes
NBW, CGA
Device Description
The Assure Prism multi Blood Glucose Monitoring System (BGMS) consists of a multi use blood glucose meter, test strips, and control solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately).
The Assure Prism multi BGMS are based on an electrochemical biosensor technology (electrochemical). The System measures the glucose level in whole blood samples using a small electrical current generated in the test strips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips and alternative sites (forearm, palm, thigh, and calf)
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
multiple-patient use in 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)
Disinfection study was performed on the meter by an outside commercial testing service to evaluate effectiveness of disinfectants, Dispatch® Hospital Cleaner Disinfectant Towels with Bleach (EPA Reg. No: 56392-7), CaviWipes1 (EPA Reg. No: 46781-13), and PDI ®Super Sani-Cloth® Germicidal Disposable Wipe (EPA Reg. No: 9480-4) in preventing the spread of blood-borne pathogens, using hepatitis B virus (HBV). The results demonstrated complete inactivation of live virus inoculated on the materials of the meter. We have also demonstrated that 10,950 each of cleaning and disinfection cycles for meter with the same disinfectant designed to simulate 3 years of multiple-patient use has no effect on the performance or the external materials of the meter.
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2015
I-SENS, INC. JOON JUNG RA TEAM MANAGER 43, BANPO-DAERO 28-GIL, SEOCHO-GU 137-873 SEOUL KOREA
Re: K151164
Trade/Device Name: Assure Prism multi Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW Dated: July 9, 2015 Received: July 10, 2015
Dear Joon 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.htm.
Sincerely yours,
Yung W. Chan -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
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Indications for Use
510(k) Number (if known) K151164
Device Name
Assure Prism multi Blood Glucose Monitoring System
Indications for Use (Describe)
The Assure® Prism multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites (forearm, palm, thigh, and calf). Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for use outside the body (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. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
Assure® Prism multi Blood Glucose Test Strips are for use with the Assure® Prism multi blood glucose meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
| 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) |
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i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 137-873, Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514
510(k) Summary
(As required by 21 CFR 807.92)
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of 510(k) | Special 510(k) |
| Submitter
Information | i-SENS, Inc.
43, Banpo-daero 28-gil, Seocho-gu 137-873, Seoul, Korea
Tel.) +82-2-916-6191
Fax) +82-2-942-2514
e-mail: jhjung@i-sens.com
Contact Person: Joon Ho Jung |
| Prepared Date | April, 29th, 2015 |
| Device Name
and
Classification | Trade name: Assure Prism multi Blood Glucose Monitoring System
Common name: Blood Glucose Test System
Classification product code: NBW, CGA
Regulation number: 21 CFR 862.1345 Glucose Test System
Classification panel: 75, Chemistry
Device class: Class II |
| Predicate Device
Information | Device name: ACURA Plus Multi Blood Glucose Monitoring System
510(k) number: K131419 |
| Device
Description | The Assure Prism multi Blood Glucose Monitoring System (BGMS) consists of a
multi use blood glucose meter, test strips, and control solutions with two
different glucose concentrations ("Control A" and "Control B" ranges, sold
separately).
The Assure Prism multi BGMS are based on an electrochemical biosensor
technology (electrochemical). The System measures the glucose level in whole
blood samples using a small electrical current generated in the test strips. |
| Intended Use: | The Assure Prism multi Blood Glucose Monitoring System is intended for the
quantitative measurement of glucose in fresh capillary whole blood samples drawn
from the fingertips and alternative sites (forearm. palm. thigh. and calf). |
4
| Alternative site testing should be used only during steady-state blood glucose
conditions. The system is intended for use outside the body (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. The system is only used with auto-
disabling, single use lancing device. It is not intended for use on neonates and is not
for the diagnosis or screening diabetes.
Assure Prism multi Blood Glucose Test Strips are for use with the Assure Prism
multi blood glucose meter to quantitatively measure glucose in fresh capillary whole
| blood samples drawn from the fingertips and alternatives sites. | |||
|---|---|---|---|
| Comparison to | |||
| the Predicate | |||
| Device | The candidate device and the predicate device consist of the same meter and test | ||
| strips. The measurement principle, fundamental scientific technology, operating | |||
| ranges, and performance characteristics of the candidate device remain the same | |||
| as those of the predicate device. Assure Prism multi has not changed since its CLIA | |||
| categorization. Additional 3 disinfectants have been validated in order to be used | |||
| with the system upon clearance. Accordingly, there have been some labeling | |||
| changes made in accordance with the addition of the 3 disinfectants. The differences | |||
| in appearance of meter and test strips are as follows. | |||
| Features | ACURA Plus Multi BGMS | ||
| (Predicate device, K131419) | Assure Prism multi BGMS | ||
| (Candidate device | |||
| K151164/CR140257) | |||
| Meter | |||
| shell | Differences in meter button symbols (functions remain the same) | ||
| Image: ACURA Plus Multi BGMS meter | Image: Assure Prism multi BGMS meter |
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| | Strip
Logo | | |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--|
| | Image: ACURA strip | Image: arkray strip | |
| Type of Test | Quantitative, Amperometric method, Glucose oxidase ( Aspergillus sp. ) | | |
| Test Principle | The reagent on the test strip produces a small electrical current using glucose as a
substrate in the blood sample. The meter converts electrical current to glucose
concentration. | | |
| Summary of
Pre-cleaning
and Disinfection | The device is intended for multiple patients use in a professional healthcare setting.
Disinfection study was performed on the meter by an outside commercial testing
service to evaluate effectiveness of disinfectants, Dispatch® Hospital Cleaner
Disinfectant Towels with Bleach (EPA Reg. No: 56392-7), CaviWipes1 (EPA Reg.
No: 46781-13), and PDI ®Super Sani-Cloth® Germicidal Disposable Wipe (EPA
Reg. No: 9480-4) in preventing the spread of blood-borne pathogens, using hepatitis
B virus (HBV). The results demonstrated complete inactivation of live virus
inoculated on the materials of the meter. | | |
| | We have also demonstrated that 10,950 each of cleaning and disinfection cycles for
meter with the same disinfectant designed to simulate 3 years of multiple-
patient use has no effect on the performance or the external materials of the meter. | | |
| Conclusion | Based on the submitted information in this premarket notification, the
candidate device is substantially equivalent to the predicate device. Further,
the candidate device has met the performance, safety, and effectiveness of the
device for its intended use. | | |