FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM

K093712 · Taidoc Technology Corporation · NBW · Feb 19, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093712
• Device Name: FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 19, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This system is intended for use outside the body (in vitro diagnostic use only). It is used for the quantitative measurement of glucose in fresh capillary whole blood samples taken from the palm, forearm, upper arm, calf, thigh, or fingers. It is not intended for the diagnosis of or screening for diabetes mellitus, or for use on neonates. This system provides you with plasma equivalent results.

Device Story

System comprises glucose meter, test strips, and control solutions; utilizes electrochemical biosensor technology with glucose oxidase to measure glucose in capillary whole blood. Operated by patients at home or healthcare professionals in clinical settings. Device processes electrical signals from test strip reaction to provide plasma-equivalent glucose concentration output. Results assist users in monitoring diabetes control programs. Modifications from predicate include software updates, physical appearance changes, and engineering adjustments.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements (21 CFR 820.30) to confirm that modifications did not impact safety or effectiveness.

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme; capillary whole blood input; plasma-equivalent output; handheld meter form factor; software-controlled; intended for OTC and professional use.

Indications for Use

Indicated for single-patient, in vitro quantitative blood glucose monitoring in fresh capillary whole blood from the finger; intended for home use by individuals with diabetes to monitor glycemic control; not for neonatal use or diabetes diagnosis/screening.

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 G30/TD-4241 Blood Glucose Monitoring System (K090187)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k093712

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the FORA G71a Blood Glucose Monitoring System, TD-4274 Blood Glucose Monitoring System:

1. The name and 510(k) number of Taidoc Technology Corporation's previously cleared device, FORA G30 Blood Glucose Monitoring System, Model TD-4241, cleared under k090187. (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.
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 software modifications for no-code (autocode), removed the following: AC/PC mode, reminder alarm, ketone warning, PC communication, and strip eject button; reduced memory to 20 sets and added measuring units in mg/dL only. Engineered for a smaller streamline size and labeling changes to address these modifications.

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.