U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM

K113768 · Taidoc Technology Corporation · LFR · Apr 12, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113768
• Device Name: U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Taidoc Technology Corporation
• Product Code: LFR · Clinical Chemistry
• Decision Date: Apr 12, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The U-RIGHT TD-4280 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. It is intended to be used by a single person and should not be shared. The U-RIGHT TD-4280 Blood Glucose Monitoring System is 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. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates. The meter contains speaking functions but is not intended for use by visually impaired users. The U-RIGHT TD-4280 Blood Glucose Test Strips are for use with the U-RIGHT TD-4280 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.

Device Story

System measures glucose in fresh capillary whole blood via electrochemical biosensor technology using glucose dehydrogenase; consists of meter, test strips, and control solutions. Used by patients at home for diabetes management. Meter features speaking function and RS-232 data transmission. User applies blood sample to test strip; meter processes signal to display quantitative glucose result. Output aids patients in monitoring diabetes control effectiveness. Modifications from predicate include added speaking function, physical design changes, reduced memory capacity (450 measurements), and updated data interface.

Clinical Evidence

Bench testing only. System accuracy performance compared to predicate device demonstrated substantial equivalence. Software verification and validation testing confirmed performance, safety, and effectiveness equivalent to the predicate.

Technological Characteristics

Glucose meter; RS-232 data transmission; speaking function; memory capacity 450 measurements. Materials validated for 5,000 cleaning/disinfection cycles. Fundamental scientific technology identical to predicate TD-4277.

Indications for Use

Indicated for single-patient use for the monitoring of blood glucose levels.

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

• TD-4277 Blood Glucose Monitoring System (K100322)

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 k113768

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.) k100322 TD-4277 Blood Glucose Monitoring System.
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. The name of the device has changed from "TD-4277 Blood Glucose Monitoring System" to "U-RIGHT TD-4280 Blood Glucose Monitoring System"
B. Addition of the speaking function. The speaking function required (1) a software change and (2) a labeling change
C. The physical appearance of the meter has slightly changed from a circular to a rectangle shape.
D. The weight of the meter (without batteries) has changed from 67.2 g to 48.8 g.
E. The data transmission method has changed from USB to RS-232 interface.
F. The memory capacity was reduced from 1,000 to 450 measurements.
G. The backlight function was removed from the device.

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

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recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

The U-RIGHT TD-4280 Blood Glucose Monitoring System is intended for single-patient use only. Disinfection efficacy studies were performed by an outside service to evaluate the virus elimination effectiveness of disinfecting wipes. Micro-Kill Plus disinfectant wipes (Medline, EPA Reg. No. 59894-10-37549) were validated demonstrating complete inactivation of duck hepatitis B virus on materials from the TD-4280 meter. The sponsor does not market a lancing device for use with the device. The sponsor performed robustness studies and demonstrated that there was no change in performance or in the external materials of the meter after 5,000 cleaning and disinfection cycles designed to simulate 5 years of single patient device use. Each robustness cycle consisted of one pre-clean wipe and one disinfection wipe. Labeling has been reviewed for adequate instructions in validated cleaning and disinfection procedures.