U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System

K151100 · Taidoc Technology Corporation · NBW · Sep 29, 2015 · Clinical Chemistry

Device Facts

• Record ID: K151100
• Device Name: U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 29, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

U-RIGHT TD-4116 Blood Glucose Monitoring System: The U-RIGHT TD-4116 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-RIGHT TD-4116 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. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates. The alternative site testing in this system can be used only during steady-state blood glucose conditions (when glucose is not changing rapidly). U-RIGHT TD-4116 Pro Blood Glucose Monitoring System: The U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by professionals testing with capillary whole blood samples. The U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by health care professionals in clinical settings as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates. The system is only used with single-use, auto-disabling lancing devices. The alternative site testing in this system can be used only during steady-state blood glucose conditions (when glucose is not changing rapidly).

Device Story

The U-RIGHT TD-4116 and TD-4116 Pro are blood glucose monitoring systems. The device accepts fresh capillary whole blood samples via test strips. It utilizes electrochemical sensing technology to measure glucose concentration, displaying results on an integrated screen. Used in clinical or home settings, the device is operated by patients or healthcare professionals. Modifications from the predicate include reduced physical dimensions and weight, addition of meal-time categorization and daily alarms, power source reduction to a single AAA battery, removal of alternative site testing (calf/thigh) and speaking functions, and updated cleaning/disinfection protocols for multi-patient use. The system provides quantitative glucose readings to assist in diabetes management.

Clinical Evidence

Performance evaluated via clinical and non-clinical studies comparing subject devices to YSI 2300 Glucose Analyzer (calibrated with NIST SRM 917A). Studies confirmed accuracy and substantial equivalence to the predicate device. No specific sensitivity/specificity metrics provided in summary.

Technological Characteristics

Electrochemical glucose sensing. Powered by one 1.5V AAA battery. Dimensions: 89mm x 52mm x 17mm; weight: 47g. Multi-patient use model (Pro) validated for cleaning/disinfection with Micro-Kill+ wipes (EPA reg 59894-10-37549).

Indications for Use

Indicated for the quantitative measurement of glucose in fresh capillary whole blood from the finger. Intended for single-patient use (TD-4116) or multiple-patient use (TD-4116 Pro) by healthcare professionals or patients for monitoring 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

• U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System (K090188)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER K151100

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.) U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System (K090188)

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. Changing the meter dimensions from 96mm(L) x 45 mm (W) x 23 mm (H) to 89mm(L) x 52 mm (W) x 17 mm (H). The thickness of the housing has also been reduced, resulting in a decrease in the weight of the meter from 71 g to 47 g (without the battery).

B. Additional (optional) user modes have been added to categorize if results are obtained before or after meals.

C. Four (optional) daily alarms have been added.

D. Power source has been changed from two 1.5 V AAA batteries to one 1.5 V AAA battery.

E. The open vial stability claim for the test strips is increased from three months to six months.

F. Calf and thigh are removed as alternative testing sites.

G. Speaking function has been removed.

H. Incorporating new validated cleaning and disinfection protocols into the labeling..

I. The name of the device was changed from the U-RIGHT TD-4227 No Coding Blood Glucose Monitoring System to the U-RIGHT TD-4116 Blood Glucose Monitoring System and U-RIGHT TD-4116 Pro Blood Glucose Monitoring System.

J. The labeling has been changed to reflect the other changes to the system.

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

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

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 modifications 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 device.

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Infection Control Studies: The U-RIGHT TD-4116 Blood Glucose Monitoring System is intended for single patient use and the U-RIGHT TD-4116 Pro Blood Glucose Monitoring System is intended for multiple-patient use. Disinfection efficacy testing was conducted by outside testing facilities and demonstrated complete inactivation of hepatitis B virus (HBV) with Micro-Kill+ (Micro-Kill Plus) Professional Disinfecting Wipes (EPA registration number 59894-10-37549). Robustness studies were performed by the sponsor demonstrating that there were no changes in the performance or external materials of the meter after 10,950 cycles of cleaning and disinfection with Micro-Kill+ (Micro-Kill Plus) Professional Disinfecting Wipes. The robustness studies were designed to simulate 3 years of multiple patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.