FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM

K100405 · Taidoc Technology Corporation · CGA · Jul 9, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100405
• Device Name: FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Taidoc Technology Corporation
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jul 9, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The FORA G90 Perform Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, forearm, upper arm, calf, or 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 programs. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

System comprises meter, test strips, and control solutions; utilizes electrochemical biosensor technology with glucose oxidase to measure glucose in fresh capillary whole blood. Designed for home use by patients with diabetes or by healthcare professionals. Device provides quantitative glucose readings to assist in monitoring diabetes control programs. Modifications from predicate include implementation of 'no-coding' functionality and preset mg/dL measurement units. Users apply blood sample to test strip; meter processes signal to display glucose concentration. Results aid in clinical decision-making regarding diabetes management. Not for diagnostic or screening purposes; not for neonatal use.

Clinical Evidence

Bench testing only. System accuracy performance was compared to the predicate device (K091898). Software verification and validation testing confirmed performance, safety, and effectiveness are equivalent to the predicate.

Technological Characteristics

Electrochemical blood glucose monitoring system. Software-controlled measurement. Modification: firmware update to disable code display and lock units to mg/dL. Fundamental sensing technology unchanged from predicate.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (finger, palm, forearm, upper arm, calf, thigh) for healthcare professionals and patients with diabetes mellitus to monitor diabetes control. Not for diabetes diagnosis/screening or neonatal use.

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 G90/U-RIGHT TD-4234 Blood Glucose Monitoring System (K091898)

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: k100405

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) for the FORA G90 Perform Blood Glucose Monitoring System.

1. The name and 510(k) number of TaiDoc Technology Corporation's previously cleared device, FORA G90 Blood Glucose Monitoring System/ U-Right TD-4234 Blood Glucose Monitoring System, cleared under k091898. (For a preamendments device, a statement to this effect has been provided.)

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 modifications to the software to: 1) turn off the code display on the screen so that the test strip code number is not displayed when the test strip is inserted and 2) to use mg/dL as the only unit of measurement.

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

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.