CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM

K063212 · Taidoc Technology Corporation · NBW · Nov 22, 2006 · Clinical Chemistry

Device Facts

• Record ID: K063212
• Device Name: CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 22, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The TD-4231 and TD-4223 blood glucose monitoring systems are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, forearm, or upper arm. The systems are intended for use by a single person and should not be shared. The systems are intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The systems are not intended for the diagnosis of or screening for diabetes mellitus, nor for use on neonates.

Device Story

System measures glucose in fresh capillary whole blood via finger or alternative sites (palm, forearm, upper-arm, calf, thigh). Used by healthcare professionals and patients with diabetes at home to monitor glycemic control. Not for diagnosis or screening. Operates via electrochemical biosensor technology; blood sample applied to test strip; meter calculates glucose concentration; results displayed on screen. Assists in diabetes management; alternative site testing limited to steady-state conditions.

Clinical Evidence

No clinical data provided in the summary document.

Technological Characteristics

In vitro diagnostic blood glucose monitoring system. Features LCD display with range indicators, strip ejector mechanism, manual code entry interface, and optional audio output. Operates via electrochemical biosensor technology. Software-controlled features include range classification and alarm scheduling.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from finger, palm, forearm, or upper arm for single-patient self-testing by individuals with diabetes to monitor glycemic control. Not for neonatal use or diabetes screening/diagnosis.

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 k063212

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.) k061181
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:

A. An engineering change in the mechanical appearance and the addition of a strip ejector switch for the TD-4231. The strip can still be removed by hand as in previous device model.
B. Calibration is accomplished through entry of a code on the strip label rather than a code strip that is included with the test strips (which was the method used in the previous device model).
C. Added result indicators to the LCD display to indicate whether the result falls within the predefined low, normal, or high range.
D. Optional alarm function to remind the user to test control material daily on the TD-4231.
E. Added a speaking function to the TD-4223 which can be turned on or off. The visual display is always on.

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

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.