CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243

K081144 · Taidoc Technology Corporation · NBW · Jun 23, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081144
• Device Name: CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in the CLEVER CHEK Auto-Code Voice Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions. This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Device Story

Glucose meter and test strips; measures blood glucose levels. Modification introduces 'one code' feature; user verifies meter display matches test strip code during use; eliminates manual entry of multiple codes. Device appearance and weight updated. Used by patients for self-monitoring or clinicians in point-of-care settings. Output displayed on meter screen; informs glycemic control decisions. Benefits include simplified user interaction and reduced potential for manual coding errors.

Clinical Evidence

Bench testing only; no clinical data provided in the summary.

Technological Characteristics

Glucose meter and test strips; electrochemical sensing principle. Modification: single code feature assigned during manufacturing. Physical characteristics: updated meter appearance and weight. Design controls per 21 CFR 820.30.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from finger, palm, forearm, upper-arm, calf, and thigh. For use by healthcare professionals and people with diabetes mellitus to monitor diabetes control. Not for diagnosis or screening of diabetes; not for use on neonates. Alternative site testing restricted to steady-state blood glucose conditions.

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 k081144

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.) k072039
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.

This change was for utilizing a single code ("one code") feature for the glucose meter and test strips. This differs from predicate device glucose meter and test strips that utilized a "no coding" feature. Since the single code has been assigned during the manufacturing of the test strips, the user does not need to enter a code for the test strips, but checks the meter display to ensure that the code for the test strips is the same. In addition, the appearance and weight of the meter were changed.

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.

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.