BASESENS BLOOD GLUCOSE MONITORING SYSTEM

K093475 · Hygeia, Inc. · NBW · Feb 24, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093475
• Device Name: BASESENS BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Hygeia, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BaseSens I Blood Glucose Monitoring System is used for the quantitative measurement of glucose levels in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. The BaseSens I Blood Glucose Monitoring System should be used only for testing outside the body (in vitro diagnostic use only). The BaseSens I Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions. BaseSens I Test Strip is used with the BaseSens I Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The BaseSens I Test Strip is intended for self-testing outside the body (in vitro diagnostic use only). The BaseSens I Test Strips are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions. BaseSens I Control A&B Solutions are 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.

Device Story

BaseSens I Blood Glucose Monitoring System is a rebranded i-Sens CareSens N system. Device measures glucose in fresh capillary whole blood samples using test strips. Principle of operation: amperometric method; glucose oxidase chemical reaction; instrument measures current proportional to glucose concentration. Used by patients at home or clinicians in clinical settings. Output: quantitative glucose level displayed on meter. System includes meter, test strips, and control solutions. Provides aid in diabetes management; not for diagnosis or screening. Features automatic code identification, 250-test memory, and post-meal flagging.

Clinical Evidence

No new clinical data provided. Performance characteristics, including precision, linearity, analytical specificity, and method comparison, were established in the predicate submissions (k080923 and k083468).

Technological Characteristics

Amperometric measurement principle using glucose oxidase enzyme and carbon electrodes. Test time: 5 seconds. Sample volume: 0.5 µL. Test range: 20-600 mg/dL. Hematocrit range: 20-60%. Features automatic code identification, 3-button interface, and memory for 250 tests. Powered by battery (implied).

Indications for Use

Indicated for quantitative measurement of glucose in capillary whole blood to monitor diabetes management effectiveness. For home or clinical use. Not for neonates, diagnosis, or screening of diabetes. Testing sites: fingertip, forearm, palm, thigh, calf (AST only during steady-state).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• i-Sens CareSens Blood Glucose Monitoring System (K080923)
• CareSens N Blood Glucose Monitoring System (K083468)

Submission Summary (Full Text)

{0}------------------------------------------------

093475

## SUMMARY OF SAFETY AND EFFECTIVENESS

February 16, 2010

FEB 2 4 2010

Trade Name: BaseSens I Blood Glucose Monitoring System Common Name: Blood Glucose Monitoring System Classification Name: System, Test, Blood Glucose, Over the Counter Classification Panel: Clinical Chemistry

Applicant:

Eran Bashan, Ph.D. President

Hygieia, Inc. 330 E. Liberty Street Ann Arbor, MI 48104 USA Tel: [phone] Cell: 734-316-2227 Fax: [phone]

All questions and/or comments concerning this document should be made to:

Robert J. Bard, Esq. Managing Director

HealthCare Technologies Consultants PO Box 506 South Lyon, MI 48178 USA Tel: [phone] Cell: 734-330-5990

{1}------------------------------------------------

#### DESCRIPTION OF THE PRODUCT 1.0

The BaseSens I Blood Glucose Monitoring System is identical to the i-Sens CareSens N Blood Glucose Monitoring System. The Hygieia BaseSens I Blood Glucose Monitoring System is a rebranded CareSens N System. Rebranding here is intended to be understood as all components of the CareSens N System have been relabeled with the Hygieia name BaseSens I or BaseSens I Blood Glucose Monitoring System.

As fully identical to the i-Sens CareSens N Blood Glucose Monitoring System, the BaseSens I Blood Glucose Monitoring System is thereby substantially equivalent to the i-Sens CareSens N Blood Glucose Monitoring System.

- The Hygieia, Inc. BaseSens I Blood Glucose Monitoring System 1.1

| Classification or descriptor | Name or designation |
|------------------------------|--------------------------------------------------|
| Trade Name | BaseSens I Blood Glucose Monitoring System |
| Common Name | Blood Glucose Monitoring System |
| Classification Name | System, Test, Blood Glucose, Over the<br>Counter |
| Classification Panel | Chemistry |
| Product Code | NBW (also CGA and JJX) |
| Regulation Number | 862.1345 |

- The System includes the BaseSens 1 blood glucose meter, test 1.1.1 strips and controls
#### 2.0 PREDICATE DEVICES

- 2,1 i-Sens CareSens Blood Glucose Monitoring System K080923 and the CareSens N Blood Glucose Monitoring System (k083468) are manufactured by i-SENS, Seoul, South Korea.
- The device under review is also manufactured by i-SENS, 2.1.1 Seoul, South Korea. The BaseSens I Blood Glucose Monitoring System is a re-branding of the CareSens N System and is substantial equivalent to the CareSens N System.

#### INDICATIONS FOR USE 3.0

- The BaseSens I Blood Glucose Monitoring System and the CareSens N 3.1 System have the following indications for use.

| BaseSens I Blood Glucose Monitoring System | CareSens N Blood Glucose Monitoring System |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| The BaseSens I Blood Glucose Monitoring<br>System is used for the quantitative measurement<br>of glucose levels in capillary whole blood as an<br>aid in monitoring the effectiveness of diabetes<br>management at home or in clinical settings. The<br>BaseSens I Blood Glucose Monitoring System<br>should be used only for testing outside the body | Same |

{2}------------------------------------------------

| (in vitro diagnostic use only). The BaseSens I Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| BaseSens I Test Strip is used with the BaseSens I Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The BaseSens I Test Strip is intended for self-testing outside the body (in vitro diagnostic use only). The BaseSens I Test Strips are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions. | Same |
| BaseSens I Control A&B Solutions are 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. | Same. |

#### 4.0 DEVICE DESCRIPTIONS

- 4.1 Specifications
- 4.1.1 The BaseSens I Blood Glucose Monitoring System and the CareSens N Blood Glucose Monitoring System including the following identical system components.
- 4.1.1.1 BaseSens | Meter (included in the System package)
- BaseSens I Test strips (included in the System 4.1.1.2 package)
- BaseSens I Control Solutions. The Control 4.1.1.3 Solutions are not included in the System package. This component can be purchased separately.
- The BaseSens I Blood Glucose Monitoring System and the 4.1.2 CareSens N Blood Glucose Monitoring System have identical product specifications.
- 4.2 Materials
- The components used in the manufacture of the BaseSens I 4.2.1 meter are identical to those of the i-Sens CareSens N meter.

{3}------------------------------------------------

- The components used in the manufacture of the BaseSens I 4.2.2 test strips are identical to those of the i-Sens CareSens N test strips.
- 4.2.3 The components used in the manufacture of the BaseSens I control solution are identical to those of the i-Sens CareSens N control solution.

#### COMPARISON OF BASESENS SYSTEM AND ITS PREDICATES 5.0

| Device Features | | | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | BaseSens I BGMS | CareSens N BGMS | CareSens BGMS |
| Enzyme | Glucose Oxidase | Glucose Oxidase | Glucose Oxidase |
| Measurement<br>Principle | Amperometric method | Amperometric method | Amperometric method |
| Test Principle | Glucose oxidase<br>chemical reaction.<br>The instrument<br>measures the extent<br>of current cause by<br>presence of glucose<br>in sample. | Glucose oxidase<br>chemical reaction.<br>The instrument<br>measures the extent<br>of current cause by<br>presence of glucose<br>in sample. | Glucose oxidase<br>chemical reaction. The<br>instrument measures the<br>extent of current cause<br>by presence of glucose<br>in sample, |
| Intended use | The test strips work<br>with the device to<br>quantitatively<br>measure glucose in<br>capillary whole blood.<br>The test Strips are for<br><i>in vitro</i> (i.e., outside<br>the body) diagnostic<br>use only. | The test strips work<br>with the device to<br>quantitatively<br>measure glucose in<br>capillary whole blood.<br>The test Strips are for<br><i>in vitro</i> (i.e., outside<br>the body) diagnostic<br>use only. | The test strips work with<br>the device to<br>quantitatively measure<br>glucose in capillary<br>whole blood. The test<br>Strips are for <i>in vitro</i> (i.e.,<br>outside the body)<br>diagnostic use only. |
| Sample | Fresh capillary whole<br>blood | Fresh capillary whole<br>blood | Fresh capillary whole<br>blood |
| Electrode | Carbon | Carbon | Carbon |
| Calibration | Plasma-equivalent | Plasma-equivalent | Plasma-equivalent |
| Test Time (seconds) | 5 | 5 | 5 |
| Sample volume (µL) | 0.5 | 0.5 | 0.5 |
| Memory | 250 | 250 | 250 |
| Test Range(mg/dL) | 20~600 | 20~600 | 20~600 |

{4}------------------------------------------------

| Hematocrit range<br>(%) | 20~60 (below<br>400mg/dL) | 20~60 (below<br>400mg/dL) | 20~60 (below 400mg/dL) | | |
|--------------------------------------------------------|----------------------------------|----------------------------------|-------------------------------------------------------|--|--|
| Glucose units | Either mg/dL or<br>mmol/L | Either mg/dL or<br>mmol/L | Either mg/dL or mmol/L | | |
| Checking the<br>system | Control solution | Control solution | Control solution | | |
| Alternate Site<br>Capability | Yes | Yes | Yes | | |
| Operating Humidity | 10~90% | 10~90% | 10~90% | | |
| Differences | | | | | |
| ltem | BaseSens I BGMS | CareSens N BGMS | CareSens BGMS | | |
| Coding | Automatic code<br>identification | Automatic code<br>identification | Manual input by button | | |
| Self-diagnosis of<br>code identification<br>function | Yes | Yes | No | | |
| Three time set<br>Alarms and 2-hour<br>post-meal Alarm | Yes | Yes | No | | |
| Post-meal flagging | Yes | Yes | No | | |
| Number of buttons | 3 buttons | 3 buttons | 2 buttons (CareSens II)<br>1 button (CareSens<br>POP) | | |

Conclusion: The BaseSens | Blood Glucose Monitoring System does not raise any new safety and efficacy concerns when compared to the cleared CareSens N Blood Glucose Monitoring System.

The BaseSens I Blood Glucose Monitoring System is identical to the i-Sens CareSens N Blood Glucose Monitoring System. The Hygieia BaseSens I Blood Glucose Monitoring System is a rebranded CareSens N Blood Glucose Monitoring System. As fully identical to the i-Sens CareSens N Blood Glucose Monitoring System, the BaseSens I Blood Glucose Monitoring System is thereby substantially equivalent to the i-Sens CareSens N Blood Glucose Monitoring System.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or other bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird image.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

FEB 2 4 2010

Hygieia, Inc. c/o Healthcare Technologies Consultants Robert J. Bard, Esq. Managing Director P.O. Box 506 South Lyon, MI 48178

> k093475 Trade/Device Name: BaseSens I Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: January 17, 2010 Received: January 19, 2010

Dear Robert J. Bard:

Re:

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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{6}------------------------------------------------

### Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. 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 [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Signature

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

# Indication for Use

510(k) Number (k093475):

Device Name: BaseSens I Blood Glucose Monitoring System

Indication for Use: The BaseSens I Blood Glucose Monitoring System is used for the quantitative measurement of glucose levels in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. The BaseSens I Blood Glucose Monitoring System should be used only for testing outside the body (in vitro diagnostic use only). The BaseSens I Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions.

BaseSens I Test Strip is used with the BaseSens I Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The BaseSens I Test Strip is intended for self-testing outside the body (in vitro diagnostic use only). The BaseSens I Test Strips are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions.

BaseSens I 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 X (21 CFR Part 801 Subpart D) Over the Counter Use x (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

and/or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k093425