CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS

K051936 · Taidoc Technology Corporation · NBW · Aug 8, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051936
• Device Name: CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

These Clever Chek TD-3215™ / Dr. T TD-3216™ Blood Glucose and Blood Pressure Measurement Systems are intended for in vitro diagnostic use. These systems are intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates. These systems are also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".

Device Story

Device modification involving change to mechanical appearance of top cover. Subject device is a modification of previously cleared device (K042795). Fundamental scientific technology remains unchanged. Modification assessed via design control activities, risk analysis, and verification/validation testing to ensure safety and performance.

Clinical Evidence

No clinical data; bench testing only via design control verification and validation activities.

Technological Characteristics

Mechanical modification to device top cover; fundamental scientific technology unchanged from predicate (K042795).

Indications for Use

Indicated for quantitative glucose measurement in capillary whole blood (fingertip) for diabetes management in patients with diabetes mellitus; not for neonates or diabetes diagnosis/screening. Also indicated for non-invasive systolic/diastolic blood pressure and pulse rate measurement in adults >16 years old with wrist circumference 5.25"-7.75".

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 k051936

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.) k042795
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 of the top cover of the device.

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

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.