TRUEBALANCE BLOOD GLUCOSE SYSTEM

K090495 · Home Diagnostics, Inc. · NBW · Mar 27, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090495
• Device Name: TRUEBALANCE BLOOD GLUCOSE SYSTEM
• Applicant: Home Diagnostics, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 27, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The TRUEbalance Blood Glucose System is intended for the quantitative determination of glucose in human capillary whole 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. The alternative site (forearm) testing for the TRUEbalance Blood Clucose System can be used only during steady-state blood glucose conditions. The TRUEbalance Blood Glucose System is not intended for the diagnosis of or screening for diabetes mellitus.

Device Story

TRUEbalance blood glucose monitoring system; modified from predicate to utilize universal calibration code. Modification involves replacing multiple test strip calibration codes with single code stored on non-removable, embedded code chip; removal of external code chip port from meter housing. Device measures glucose in capillary whole blood; intended for patient self-testing. Healthcare providers use output to monitor glycemic control. Modification maintains fundamental scientific technology of predicate.

Clinical Evidence

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

Technological Characteristics

Electrochemical glucose test system; capillary whole blood sensing; quantitative measurement; intended for OTC and professional use.

Indications for Use

Indicated for use by patients with diabetes for the quantitative measurement of glucose in capillary whole blood.

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 (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k090495

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 (labeling changes are permitted as long as they do not affect the intended use).
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.

The device has been modified from the use of multiple codes for test strip calibration in the predicate to the use of a single code in the new device. The universal code is stored on a non-removable code chip embedded in the TRUEbalance meter.

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

The differences are 1) a single calibration code programmed onto a code chip which is embedded inside the meter and 2) removal of code chip port from the outer meter case.

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 included:

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.