CLEVER CHEK TD-4225, MODEL TD-4225

K051854 · Taidoc Technology Corporation · NBW · Aug 5, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051854
• Device Name: CLEVER CHEK TD-4225, MODEL TD-4225
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 5, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Clever Chek TD-4225 Blood Glucose Test System is intended for use in the quantitative measurement of glucose in whole blood taken from the finger. 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.

Device Story

Clever Chek TD-4225 Blood Glucose Test System; quantitative measurement of glucose in capillary whole blood; finger-stick samples; intended for home use by patients with diabetes and professional use in clinical settings; aids in monitoring diabetes control programs; not for diagnostic or screening purposes; not for neonatal use.

Clinical Evidence

No clinical data provided. Substantial equivalence established via design control activities, risk analysis, and verification/validation testing of modified functions.

Technological Characteristics

Glucose test system; electrochemical biosensor technology; capillary whole blood sample; intended for finger-stick use; standalone device.

Indications for Use

Indicated for quantitative blood glucose measurement in capillary whole blood from the finger. Intended for use by healthcare professionals and patients with diabetes mellitus for monitoring diabetes control. Not for diagnosis or screening of diabetes; not for use on neonates.

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.

Predicate Devices

• K041107

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 K051854

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.) k041107
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 change of the mechanical appearance and the addition of functions to the device. The change in mechanical appearance specifically entails a slight modification in the meter size and in the color of the meter itself. The following functions were added to the product: Glucose test results of >13.3mmol/L (240mg/dL) will result in a prompt for Ketone and a “?.” Readings can be selected to be stored in memory or not, readings in memory can be deleted, 450 readings may now be stored in memory, control test solution mode is not stored in memory, ambient temperature and display with temperature units of °C and °F available. Finally, the ability to add 60 and 90 day readings average function has been added.

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

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.