(85 days)
Not Found
No
The description focuses on electrochemical biosensor technology and does not mention AI or ML.
No
The device is described as a blood glucose monitoring system used for quantitative measurement of glucose, assisting in monitoring the effectiveness of diabetes control. It is explicitly stated that the system is "not for the diagnosis or screening of diabetes," and its function is to measure, not to treat or alleviate a disease, making it a diagnostic/monitoring device rather than a therapeutic one.
Yes
The device aids in monitoring the effectiveness of diabetes control by measuring glucose levels, which is a diagnostic-related function, even though it explicitly states it is not for the diagnosis or screening of diabetes.
No
The device description explicitly states the system consists of a blood glucose meter, test strips, and control solutions, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is intended for use outside the body (in vitro).
- Measurement of Glucose: The system measures glucose in blood samples, which is a biological sample.
- Aid to Monitor Diabetes Control: The system is used to monitor the effectiveness of diabetes control, which is a diagnostic purpose.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
The ACURA PLUS 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 such as the 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) 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.
The ACURA PLUS Multi Blood Glucose Test Strips are for use with the ACURA PLUS 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 ACURA PLUS Multi Blood Glucose Monitoring System (BGMS) consists of an ACURA PLUS Multi Blood Glucose Meter, ACURA PLUS Multi Blood Glucose Test Strips, and ACURA PLUS Control Solutions with three different glucose concentrations ("Control 1", "Control 2", and "Control 3" ranges). The ACURA PLUS 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. ACURA PLUS Control Solutions are used to test the performance of the system with a known range of glucose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf.
Indicated Patient Age Range
It is 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 disinfectant, CLOROX GERMICIDAL Wipes (EPA Reg. No: 67619-12), 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 pre-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.
0
K13/4/9
Image /page/0/Picture/1 description: The image shows the logo for i-sens. The logo consists of the lowercase letters 'i-sens' in a bold, sans-serif font. A stylized circle with two curved lines above it partially encloses the 'i' in 'i-sens'. The logo is simple and modern.
27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, Inc.
27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, Korea
Tel. 82-2-916-6191
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.
27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, Korea
Tel.) +82-33-903-0767
Fax) +82-33-748-6191
e-mail: cylim@i-sens.com
Contact Person: Chae Yun Lim |
| Prepared Date | May 15, 2013
AUG 09 2013 |
| Device Name
and
Classification | Trade name: ACURA PLUS 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 Blood Glucose Monitoring System
510(k) number: K103278 |
| Device
Description | The ACURA PLUS Multi Blood Glucose Monitoring System (BGMS) consists of
an ACURA PLUS Multi Blood Glucose Meter, ACURA PLUS Multi Blood
Glucose Test Strips, and ACURA PLUS Control Solutions with three different
glucose concentrations ("Control 1", "Control 2", and "Control 3" ranges).
The ACURA PLUS 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. ACURA
PLUS Control Solutions are used to test the performance of the system with a
known range of glucose. |
| Intended Use: | The ACURA PLUS 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 such as the 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 ) 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. |
| | The ACURA PLUS Multi Blood Glucose Test Strips are for use with the ACURA |
| | PLUS Multi Blood Glucose Meter to quantitatively measure glucose in fresh |
| | capillary whole blood samples drawn from the fingertips and alternative sites. |
| Comparison to | The candidate device and the predicate device consist of the same meter and test |
| the Predicate | strips. And the measurement principle, fundamental scientific technology, |
| Device | operating ranges, and performance characteristics of the candidate device are the |
| | same as those of the predicate device. However, they have separate names because |
| | of the different indications for use (single- vs. multiple-patient use). Also, there |
| | are some label changes made in accordance with the changed indications for use. |
| | Both devices use same control solutions. |
| 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 | The device is intended for multiple patients use in a professional healthcare |
| Pre-cleaning | setting. Disinfection study was performed on the meter by an outside commercial |
| and Disinfection | testing service to evaluate effectiveness of disinfectant, CLOROX GERMICIDAL |
| | Wipes (EPA Reg. No: 67619-12), 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 pre-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. |
:
1
Image /page/1/Picture/0 description: The image contains the logo for i-sens. The logo consists of the lowercase letters "i-sens" in a bold, sans-serif font. The "i" is dotted with a small circle, and the entire word is partially enclosed by a curved line that starts above the "i" and extends around the left side of the word.
2
Image /page/2/Picture/0 description: The image shows a logo for i-sens. The logo features the text "i-sens" in a bold, sans-serif font. The "i" is lowercase, and there are three curved lines above it, resembling a stylized eye or sensor. The overall design is simple and modern.
.
i-SENS, Inc. 27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
.
1999 - 1999
.
.
:
·
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 9, 2013
i-SENS, Inc. C/O Chae Yun Lim 27-36, Gwangun-ro, Nowon-gu, Seoul 139-845, Korea
Re: K131419
Trade/Device Name: ACURA PLUS Multi Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: July 10, 2013 Received: July 11, 2013
Dear Chae Yun Lim:
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). and Cosmetic rearly market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mannes of the Act include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and adviteration. 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), if your device is elassinos controls. Existing major regulations affecting your device can be it may be sucjoet to additions, 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 than Federal statutes and regulations administered by other Federal agencies. You must or any i vothat salates and encluding, but not limited to: registration and listing (2 l 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
4
Page 2-Chae Yun Lim
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/Resourcesfor You/Industry/default.htm.
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
5
Indications for Use Form
510(k) Number (if known): _k131419
Device Name: ACURA PLUS Multi Blood Glucose Monitoring System
Indications for Use:
The ACURA PLUS 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 such as the 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) 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.
The ACURA PLUS Multi Blood Glucose Test Strips are for use with the ACURA PLUS Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
AND/OR Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Katherine Serrano -S
Division Sian-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K131419
Page 1 of 1
X