SIDEKICK BLOOD GLUCOSE TEST SYSTEM

K051147 · Home Diagnostics, Inc. · NBW · Jul 12, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051147
• Device Name: SIDEKICK BLOOD GLUCOSE TEST SYSTEM
• Applicant: Home Diagnostics, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The intended use of the modified device as described in its labeling has not changed.

Device Story

Sidekick Blood Glucose Test System; in vitro diagnostic device for quantitative glucose measurement. Input: capillary whole blood sample from finger or forearm. Operation: electrochemical biosensor technology; system analyzes blood sample to determine glucose concentration. Output: numerical blood glucose value displayed to user. Usage: point-of-care; intended for both patient self-testing and healthcare professional use. Clinical utility: assists in diabetes management by providing real-time glucose data for monitoring and treatment adjustments.

Clinical Evidence

No clinical data provided; substantial equivalence established via design control activities, risk analysis, and verification/validation testing of device modifications.

Technological Characteristics

Electrochemical biosensor; quantitative glucose test system; capillary whole blood analysis; finger or forearm sampling.

Indications for Use

Indicated for quantitative blood glucose determination in capillary whole blood from finger or forearm to assist patients and healthcare professionals in diabetes management.

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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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 depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

JUL 1 2 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Karen DeVincent Director of Regulatory Affairs/ Quality Assurance Home Diagnostics, Inc. 2400 NW 55th Court Fort Lauderdale, FL 33309

k051147 Re:

Trade/Device Name: Sidekick Blood Glucose Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: June 20, 2005 Received: June 21, 2005

Dear Ms. DeVincent:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have rowe 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).

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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 premained netiretine 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):__K051147

Device Name: _ Sidekick Blood Glucose Test System

Indications For Use:

The Sidekick Blood Glucose Test System is intended for the quantitative determination The Glookin' 2100a Diole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

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

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

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

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

Albert G

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Division Sign Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K051147