CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING

K073494 · Taidoc Technology Corporation · NBW · Apr 2, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073494
• Device Name: CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The intended use of the modified device as described in its labeling has not changed.

Device Story

Blood glucose monitoring systems (meters) measure glucose levels in capillary whole blood samples. Modification involves software updates to the TD-4209, TD-4226, TD-4222, TD-4225, and TD-4207 meters. For TD-4209 and TD-4226, software now displays internal meter code for user verification against test strip vial codes. For TD-4222, TD-4225, and TD-4207, software eliminates manual user coding by utilizing an internal meter code. Devices are used by patients for self-monitoring of blood glucose. Output is a numerical glucose concentration displayed on the meter screen, assisting patients and clinicians in diabetes management.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Glucose monitoring meters utilizing electrochemical sensing technology. Modifications are limited to firmware/software logic regarding meter coding (displaying internal code or removing manual coding requirement).

Indications for Use

Indicated for the quantitative measurement of glucose in capillary whole blood as an aid in monitoring the effectiveness of diabetes control programs.

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

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k073494

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.

Easy Check TD-4209, Clever Chek TD-4222, Clever Chek TD-4225 and Clever Chek TD-4226 Blood Glucose Monitoring Systems cleared under k062235; ACHTUNG TD-4207 Blood Glucose Monitoring System cleared under 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: software change for the 4209 and 4226 glucose meters to allow the meter to display the internal meter code so that the user can verify the code on the test strip vial with the internal meter code, and software changes for the 4222, 4225, and 4207 glucose meters so there is only an internal meter code that does not require any coding by the user.

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

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.