DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM

K113343 · Delbio Incorporation · NBW · Feb 8, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113343
• Device Name: DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Delbio Incorporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 8, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The DiaCheck Superior Blood Glucose Monitoring System is intended for the rne Black our of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The DiaCheck Superior Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

Device Story

DiaCheck Superior Blood Glucose Monitoring System measures glucose levels in fresh capillary whole blood samples obtained from fingertips. Device intended for home use by individuals with diabetes to monitor glycemic control. System comprises blood glucose meter, test strips, and control solution. User applies blood sample to test strip inserted into meter; meter performs electrochemical measurement of glucose concentration. Results displayed on meter screen to assist users in managing diabetes. System designed for single-patient use; not for clinical screening, diagnosis, or neonatal testing. Control solution used to verify system accuracy and proper function of meter and strips.

Clinical Evidence

Bench testing only. Robustness studies demonstrated no change in performance or external materials after 260 cleaning and disinfection cycles using Super Sani-Cloth Germicidal Wipes (EPA #9480-4), simulating 5 years of single-patient use.

Technological Characteristics

Electrochemical glucose monitoring system; utilizes capillary whole blood samples; intended for in vitro diagnostic use.

Indications for Use

Indicated for single-patient use for the monitoring of blood glucose levels.

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.

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 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 outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and iconic, representing the HHS's role in promoting the health and well-being of the nation.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Delbio Incorporation c/o Nicky Pan 3F. No. 252, Shangying Road Guishan Industrial Zone Taoyuan County China (Taiwan) 33341

FEB - 8 2012

k113343 Re:

R1100 15 DIACHECK SUPERIOR 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: December 9, 2011 Received: January 9, 2012

Dear Nicky Pan:

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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to act resol and metic Act (Act) that do not require approval of a premarket the Federal I vou, Drag, and Coou may, therefore, market the device, subject to the general approvin approvisions of the Act. The general controls provisions of the Act include controls provisions of the samual 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 If your device to such additional controls. Existing major regulations affecting (1 Nr.), It may of says. It Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. your device can be found in Therther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not I least be advised that I DTF o lessination that your device complies with other requirements mean that I DA mas made a statutes and regulations administered by other Federal agencies. of the Act of any I ouctures and submitted including, but not limited to: registration in rou intest compt) was t 807); labeling (21 CFR Parts 801 and 809); medical device and insting (21 CF R F a v 80 - ), 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).

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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/Medical

Devices/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 [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Signature

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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DELBio Incorporation Special 510(k)

DiaCheck Smart Blood Glucose Monitoring System DiaCheck Superior Blood Glucose Monitoring System

### Indications for Use

510(k) Number (if known): K113343

Device Name: DiaCheck Smart Blood Glucose Monitoring System

Indications for Use:

DiaCheck Smart Blood Glucose Monitoring System:

The DiaCheck Smart Blood Glucose Monitoring System is intended for the quantitative rno Blacmost of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

The DiaCheck Smart Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

#### DiaCheck Smart Blood Glucose Test Strips:

The DiaCheck Smart Blood Glucose Test Strips are for use with the DiaCheck Smart Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The Test Strip is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

#### DiaCheck Glucose Control Solution:

The DiaCheck Control solutions are intended for use with DiaCheck Blood Glucose The DiaCheck Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly.

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use x (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
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| Division Sign-Off |
|--------------------------------------|
| Office of In Vitro Diagnostic Device |
| Evaluation and Safety |
| 510(k) K 11 3343 |

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DELBio Incorporation . Special 510(k)

DiaCheck Smart Blood Glucose Monitoring System DiaCheck Superior Blood Glucose Monitoring System

## Indications for Use

#### 510(k) Number (if known): K113343

Device Name: DiaCheck Superior Blood Glucose Monitoring System

Indications for Use:

### DiaCheck Superior Blood Glucose Monitoring System:

The DiaCheck Superior Blood Glucose Monitoring System is intended for the rne Black our of glucose in fresh capillary whole blood samples from the fingertips by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

The DiaCheck Superior Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

### DiaCheck Superior Blood Glucose Test Strip:

The DiaCheck Superior Blood Glucose Test Strips are for use with the DiaCheck rne Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples from the fingertip. The Test Strip is intended for self testing outside the body (in vitro diagnostic use). This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

#### DiaCheck Glucose Control Solution:

The DiaCheck Control solutions are intended for use with DiaCheck Blood Glucose The DiaCheck Blood Glucose Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is being performed correctly.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _______________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)_K 11 334