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

Indications for 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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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k051147

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k030703, k032657
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for a name change, miniaturizing the meter so that it is attached to the cap of the vial of test strips, making the meter disposable, eliminating the need for coding the meter (the meter is for use only with the test strips provided with the meter), reduction in memory capacity from 365 test results to 50 test results, removal of the function allowing users to calculate and display morning average values, test time slightly reduced, units of measure cannot be changed by the user, and no date or time appears with the test result on the display.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and all changes mentioned in number 3 above.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.