ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455

K082618 · Taidoc Technology Corporation · NBW · Oct 7, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082618
• Device Name: ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 7, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The UltraTRAK PRO Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the upper-arm, the calf and the thigh. 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. The alternative site testing in the UltraTRAK PRO Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Device Story

UltraTRAK PRO Blood Glucose Monitoring System measures glucose in fresh capillary whole blood; inputs include blood samples from finger or alternative sites (palm, upper-arm, calf, thigh). Device uses electrochemical biosensor technology to quantify glucose levels; output is numerical blood glucose concentration displayed to user. Intended for home use by patients with diabetes or clinical use by healthcare professionals. Provides real-time monitoring to assist in diabetes management; aids in assessing effectiveness of diabetes control programs. Not for diagnostic or screening purposes; alternative site testing requires steady-state conditions.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on bench testing and performance characteristics.

Technological Characteristics

Electrochemical glucose test system; utilizes capillary whole blood samples. Designed for finger and alternative site testing (palm, upper-arm, calf, thigh). System includes meter and test strips. Connectivity and specific software architecture details not provided. Sterilization and material specifications not detailed in provided text.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from finger, palm, upper-arm, calf, and thigh. For use by healthcare professionals and patients with diabetes mellitus to monitor diabetes control. Contraindicated for neonates and for diagnosis or screening of diabetes. Alternative site testing restricted to steady-state glucose conditions.

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 k082618

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.) k080501
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 adding a memory feature to store quality control solution values not available in the predicate device. The memory for control solution values is stored separately from the user blood glucose values. In comparison to the predicate, the physical appearance of the meter has been changed slightly and the unit of temperature measurement is fixed for Fahrenheit readings.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, reagents, test steps, and performance 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
c) A declaration of conformity with design controls. The declaration of conformity included:

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.