TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM

K042080 · Home Diagnostics, Inc. · JJX · Aug 19, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042080
• Device Name: TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
• Applicant: Home Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 19, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The TrackEase Smart System Blood Glucose System is intended for use in the quantitative measurement of glucose in whole blood. The system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

Device Story

TrackEase Smart System; blood glucose meter; measures glucose in whole blood samples; provides quantitative results; used by patients with diabetes at home; modification reduces memory capacity from 365 to 200 results; disables morning average calculation/display; updates meter casing appearance; fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Blood glucose monitoring system; quantitative determination of glucose in whole blood; finger or forearm sampling; Class II device (21 CFR 862.1345).

Indications for Use

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

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K042080

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 TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM:

1. The name and 510(k) number of HOME DIAGNOSTICS, INC.'s previously cleared device, TrueTack smart System blood glucose meter, cleared under K030703, K032657, K040670. (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 a reduction in the number of blood glucose results stored in meter memory from 365 to 200, the calculation and display of morning average values has been disabled and appearance of the meter casing.

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

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.

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

August 17, 2004

(Date)

revised:3/27/98