MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL

K040670 · Home Diagnostics, Inc. · NBW · Mar 25, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040670
• Device Name: MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL
• Applicant: Home Diagnostics, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 25, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

Device Story

TrueTrack Smart System; blood glucose meter, test strips, and control solution; measures glucose in whole blood; used by patients at home and healthcare professionals in clinical settings. Modification adds serial cable accessory for data transfer from meter to personal computer. Fundamental scientific technology remains unchanged from predicate. Device provides glucose monitoring data to aid diabetes management.

Clinical Evidence

Bench testing only. Validation protocols addressed hazards identified in the risk analysis (FMEA).

Technological Characteristics

Electrochemical glucose test system; quantitative measurement of glucose in whole blood.

Indications for Use

Indicated for quantitative glucose determination in human whole blood 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 K040670

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I device. The following items are present and acceptable (delete/add items as necessary) for the MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL:

1. The name and 510(k) number of HOME DIAGNOSTICS, INC.'s previously cleared device, TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL, cleared under K030703. (For a preamendments device, a statement to this effect has been provided.)
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 the inclusion of a serial cable accessory to interface the glucose meter with a personal computer to transfer blood glucose results from the meter to the computer.

Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics.

4. 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.

Comments – Validation Protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FMEA)