NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254

K092099 · Taidoc Technology Corporation · NBW · Dec 10, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092099
• Device Name: NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 10, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System, model no. TD-4251A/ TD-4252C/ TD-4253A/ TD-4254A are 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 forearm, 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 FORA TD-4251 / U-RIGHT TD-4252/ U-RIGHT TD-4253/U-RIGHT TD-4254 No-Coding Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Device Story

System consists of glucose meter, test strips, control solution, lancing device, and lancets. Uses electrochemical biosensor technology with glucose oxidase to measure glucose in fresh capillary whole blood. Operated by healthcare professionals or patients at home. Provides quantitative glucose concentration output to assist in monitoring diabetes control programs. Modifications from predicate include software updates, physical appearance changes, and associated labeling revisions.

Clinical Evidence

Bench testing only. System accuracy performance compared to predicate device. Mechanical resistance testing performed per EN ISO 15197. Software verification and validation confirmed performance, safety, and effectiveness equivalent to predicate.

Technological Characteristics

Electrochemical biosensor using glucose oxidase. Components: glucose meter, test strips, control solution, lancing device. Software-controlled. Meets EN ISO 15197 standards for mechanical resistance.

Indications for Use

Indicated for use as a blood glucose monitoring system for the quantitative measurement of glucose in capillary whole blood.

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

• FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 Blood Glucose Monitoring System (k082482)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k092099

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.) k082482 (FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 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. For models FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254, the software was modified to remove the code number selection feature and the labeling was modified to reflect the removal of the coding feature.

b. For model U-RIGHT TD-4253, the modifications include changes in physical appearance, an alteration in the arrangement of the printed circular board to fit the shape of the meter, software modification to remove the code number selection feature, and labeling modification to reflect the removal of the coding feature.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and sample type. Studies include software validation and verification activities, accuracy testing, mechanical resistance to drop and vibration, and evaluation of the effects of temperature and humidity.

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.