(78 days)
Not Found
No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components. The performance studies and validation activities focus on the accuracy and functionality of the meter and test strips, not on algorithmic learning or prediction.
No.
The device is an in vitro diagnostic device used to measure glucose levels, not to treat a condition.
Yes
Explanation: The device is used for the quantitative measurement of glucose level in capillary whole blood, which is a diagnostic measurement. However, the document explicitly states, "Do not use the system for the diagnosis or screening of diabetes." and "Do not use the system for the diagnosis of diabetes without the guidance of healthcare professional." This means it aids in monitoring effectiveness but cannot be used for the initial diagnosis of diabetes.
No
The device description explicitly lists hardware components such as the meter, test strips, control solutions, lancing device, and lancets. The performance studies also include tests related to the physical characteristics of the device (e.g., Drop Test, Vibration Test, Electrical Safety Report).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "CareSens N Blood Glucose System should be used only for testing outside the body (in vitro diagnostic use only)." and "The CareSens N Test Strip is intended for selftesting outside the body (in vitro diagnostic use only)."
- Device Description: The "Device Description" section also refers to the system as "an in vitro diagnostic device".
- Function: The device measures glucose levels in capillary whole blood, which is a biological sample taken from the body and tested in vitro (outside the body).
- Purpose: The intended use is to aid in monitoring the effectiveness of diabetes management, which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
The CareSens N Meter is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. CareSens N Blood Glucose System should be used only for testing outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis or screening of diabetes. Testing sites include the traditional fingertip testing along with alternate sites testing on forearm, palm, thigh and calf.
CareSens N Test Strip is used with the CareSens N Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The CareSens N Test Strip is intended for selftesting outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis of diabetes without the guidance of healthcare professional. Testing sites include the traditional fingertip testing along with alternate sites testing on forearm, palm, thigh and calf.
CareSens Control A&B Solutions are a red liquid to check that both the meters and test strips are working together properly. It contains a known range of glucose as written on the bottle.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX
Device Description
CareSens N Blood Glucose Monitoring System ("CareSens N BGMS") is an in vitro diagnostic device designed to measure the concentration of glucose in capillary whole blood with CareSens N Test Strips. The CareSens N model consists of the CareSens N meter (Model GM505IA, GM505IB, GM505IC: IA, IB and IC indicates the color of the devices, respectively, black, white, and light blue.), CareSens N test strips, and CareSens control solutions for two different glucose concentration ranges (called "Normal" and "Middle" ranges), lancing device, lancets, user manual, quick reference guide and a logbook.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip, forearm, palm, thigh and calf
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home or in clinical 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)
The following performance evaluation tests were conducted, with results being satisfactory:
- Repeatability Test: Precision, with concentrations
§ 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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IC083468
Image /page/0/Picture/1 description: The image shows a logo with the word "i-sens" in a stylized font. The "i" is lowercase and has a small circle above it, resembling a dot. The rest of the word, "-sens," is also lowercase. To the left of the word is a circular graphic with a complex, textured pattern inside. The overall design is simple and modern.
i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea
Tel. 82-2-916-6191
Special 510(k) SUMMARY
FEB 1 0 2009
(As required by 2I.CFR.807.87)
| Type of 510(k): | Special |
|---|---|
| Submitter's Previously Cleared Device: | Name - CareSens Blood Glucose Monitoring System |
| 510(k) number - K080923 | |
| Introduction: | This 510(k) submission contains information/data on modifications made |
| to submitter's previously cleared device. The modifications do not | |
| affect the intended use of the device or alter the fundamental scientific | |
| technology of the device. The major modifications are the addition of | |
| an automatic code identification feature, and the user interface | |
| applications: alarms and post-meal flagging. | |
| Submitted By: | i-SENS, Inc. |
| 465-6, Wolgye-dong, Nowon-gu, Seoul, 139-845, Korea | |
| Tel.) ++82-2-916-6191 | |
| Fax) ++82-2-942-2514 | |
| www.i-sens.com | |
| Contact Person: | Dr. Hyun Joon Oh, Phone: +82-33-903-0760, Fax +82-33-748-6191 |
| Date Summary was Prepared: | November 6, 2008 |
| Device Name: | Trade name: CareSens N Blood Glucose Monitoring System |
| Common Name: Blood Glucose Test System | |
| Classification Name: Class II, 862.1345 Glucose Blood Tester | |
| Predicate Device: | We claim substantial equivalence to submitter's previously cleared |
| CareSens Blood Glucose Monitoring System ("CareSens BGMS") | |
| The glucose measurement test principle: | same as CareSens BGM |
| Intended Use: | same as CareSens BGM |
| Fundamental scientific technology: | same as CareSens BGM |
:
:
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Image /page/1/Picture/0 description: The image shows the logo for i-sens. The logo consists of the word "i-sens" in a sans-serif font, with the "i" in lowercase and the rest of the word in lowercase. To the left of the word is a circular graphic made up of many small words. The words are arranged in a circular pattern, and they are all in a small font size.
i-SENS. Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
systems by i-SENS, Inc. (K080923) and the OneTouch® Ultra® Blood Glucose Monitoring System by LifeScan, Inc. (K024194).
Device Description:
CareSens N Blood Glucose Monitoring System ("CareSens N BGMS") is an in vitro diagnostic device designed to measure the concentration of glucose in capillary whole blood with CareSens N Test Strips. The CareSens N model consists of the CareSens N meter (Model GM505IA, GM505IB, GM505IC: IA, IB and IC indicates the color of the devices, respectively, black, white, and light blue.), CareSens N test strips, and CareSens control solutions for two different glucose concentration ranges (called "Normal" and "Middle" ranges), lancing device, lancets, user manual, quick reference guide and a logbook.
Comparison to Submitter's Previously Cleared Device (K080923):
Modifications:
Automatic code identification by the meter through detection of a marked pattern on each strip, so that the user does not input code information.
For the meter, the only difference is the addition of code identification sensors in the meter, while all other major elcctronic components are the same as those of CareSens BGMS. Please refer to Page 3 of Section 10 Specifications for details.
For the strip, the only difference is printing code-specific marks on the back side of each strip with infrared absorbing ink, while all the reagent components and mcasurement process are the same as those of CareSens BGMS. Please refer to Page 11 of Section 10 Specifications for details.
Alarms (Three time set alarms, and 2-hour post meal alarm) Post-meal flagging of test results Number of Buttons on the meter is three
7-2
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Image /page/2/Picture/0 description: The image shows the logo for i-SENS, a company that specializes in biosensor technology. The logo features a stylized lowercase "i" with a circular element above it, followed by the text "sens" in a bold, sans-serif font. The logo is simple and modern, reflecting the company's focus on innovation and technology.
.
:
| Common Features | ||
|---|---|---|
| Item | CareSens N BGMS | CareSens BGMS |
| Enzyme | Glucose Oxidase | |
| Measurement principle | Amperometric method | |
| Test principle | Glucose Oxidase chemical reaction. The instrument measures the extent of current cause by presence of glucose in sample. | |
| Intended use | The test strips work with the device to quantitatively measure glucose in capillary whole blood. The test Strips are for in vitro (i.e., outside the body) diagnostic use only. | |
| Sample | Fresh capillary whole blood | |
| Electrode | Carbon | |
| Calibration | Plasma-equivalent | |
| Test Time (second) | 5 | |
| Sample volume (µL) | 0.5 | |
| Memory | 250 | |
| Test Range(mg/dL) | 20~600 | |
| Hematocrit range (%) | 20~60 (below 400mg/dL) | |
| Glucose units | Either mg/dL or mmol/L | |
| Checking the system | Control solution | |
| Alternate Site | Yes | |
| Capability | ||
| Operating Humidity | 10~90% | |
| Differences | ||
| Item | CareSens N BGMS | CareSens BGMS |
| Coding | Automatic code identification | Manual input by button |
| Self-diagnosis of code | ||
| identification function | Yes | No |
| Three time set Alarms | ||
| and 2-hour post-meal | ||
| Alarm | Yes | No |
| Post-meal flagging | Yes | No |
| Number of buttons | 3 buttons | 2 buttons (CareSens II) |
| 1 button (CareSens POP) |
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i-SENS, Inc.
Image /page/3/Picture/1 description: The image shows a logo for "i-sens". The logo is composed of a stylized letter "i" followed by the word "sens". The "i" is surrounded by a circular pattern of small dots, giving it a technological or digital feel. The word "sens" is written in a bold, sans-serif font, and the overall design is simple and modern.
465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
Since for CareSens N, the glucose measurement test principle, intended use, and fundamental scientific technology are the same as the submitter's unmodified device (K080923), there is no reason to expect that the performance would be different, but most of the performance evaluation tests done for the unmodified device were repeated to confirm that performance still satisfies the acceptance criteria. For performance evaluation, the following summary table shows the tests that were repeated.
Additionally, the substantial equivalence report for comparison to OneTouch® Ultra® is provided in Section 11.
Performance evaluation summary of modified device, CareSens N BGMS
The report numbers PE-01 to PE-17 in this table indicate those of the unmodified device (K080923), and the methods used for the tests can be found in that prior application. Please note that the actual reports for tests PE-01 to PE-17 that were repeated for CareSens N, are not included in this submission. .
| Report
| No. | Title | Pre-determined Acceptance Criteria | Results | ||
|---|---|---|---|---|---|
| PE-01 | Repeatability Test | Concentration | Precision | Satisfactory | |
| 1 Page 19 of Section 14 Risk analysis: H11-C11.2 Error of code recognition function |
2 Page 19 of Section 14 Risk analysis: H11-C11.1 Error (shorted or disconnected circuit) in the infraced photoreflectors
for auto coding function
3 Page 20 of Section 14 Risk analysis: H16 software
4 Page 20 of Section 14 Risk analysis: H16 software-C16.3 Functional error of memory recall
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Image /page/6/Picture/0 description: The image shows a logo with the word "isens" in a stylized font. The "i" in "isens" is designed to look like an eye, with a circular shape above the letter. The rest of the letters in "isens" are in lowercase and have a bold, sans-serif font. The logo appears to be for a company or organization named "isens."
i-SENS, Inc. Tel. 82-2-916-6191 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea
| 15-15 | Electromagnetic Compatibility Report | It should meet the EMC test regulations given in p3 of the title report (Electronic Compatibility Report). | Satisfactory |
|---|---|---|---|
| 15-2 | Electrical Safety Report | It should comply with the test regulations given in p1 of the title report. | Satisfactory |
Conclusion:
:
All predetermined acceptance criteria were satisfied. The data also demonstrates that the CareSens N BGMS is substantially equivalent to the following predicate device systems:
K080923 - i-SENS, Inc. CareSens Blood Glucose Monitoring System K024194 - LifeScan, Inc. OneTouch® Ultra® Blood Glucose Monitoring System
్ Page 16 of Section 14 Risk analysis: H4 electromagnetic field compatibility
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The text is likely part of a document or sign, indicating an association with a public health organization.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
I-Sens, Inc. c/o Hyun Joon Oh Division Manager, Quality Assurance 465-6 Wolgye-Dong, Nowon-Gu Seoul, Republic of Korea 139-845
FEB 1 0 2009
Re: K083468
Trade Name: CareSens N Blood Glucose Monitoring System Regulation Number: 21 CFR 862, 1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW. CGA. JJX Dated: January 26, 2009 Received: January 26, 2009
Dear Hyun Joon Oh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
Image /page/7/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three bodies, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
signature
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
510(k) Number (if known): 长۵૪ 3468
Device Name: CareSens N Blood Glucose Monitoring System
Indication For Use: The CareSens N Meter is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. CareSens N Blood Glucose System should be used only for testing outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis or screening of diabetes. Testing sites include the traditional fingertip testing along with alternate sites testing on forearm, palm, thigh and calf.
CareSens N Test Strip is used with the CareSens N Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The CareSens N Test Strip is intended for selftesting outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis of diabetes without the guidance of healthcare professional. Testing sites include the traditional fingertip testing along with alternate sites testing on forearm, palm, thigh and calf.
CareSens Control A&B Solutions are a red liquid to check that both the meters and test strips are working together properly. It contains a known range of glucose as written on the bottle.
Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Yici May acting
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083468