FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264

K093005 · Taidoc Technology Corporation · NBW · Feb 5, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093005
• Device Name: FORA G72 BLODO GLUCOSE MONITORING SYSTEM/TD-4264 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4264
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 5, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The FORA G72 / TD-4264 Blood Glucose Monitoring System, FORA G70 / TD-4273 Blood Glucose Monitoring System, and Ultra Trak Active Blood Glucose Monitoring System are intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, nor for use on neonates. The alternative site testing in above systems can be used only during steady-state blood glucose conditions.

Device Story

System measures glucose concentration in fresh capillary whole blood using electrochemical biosensor test strips. Meter applies amperometry to measure electrical current generated by glucose-reagent reaction; current magnitude is proportional to glucose concentration. Used by healthcare professionals or patients at home for diabetes management. Provides quantitative glucose readings to aid in monitoring diabetes control programs. Not for diagnosis or screening. Alternative site testing requires steady-state blood glucose conditions.

Clinical Evidence

No clinical data provided; substantial equivalence established via design control activities, risk analysis, and verification/validation of software and physical modifications.

Technological Characteristics

Electrochemical biosensor (test strips) and meter. Amperometry-based measurement of electrical current. Quantitative measurement of glucose in whole blood and control solutions.

Indications for Use

Indicated for use by patients with diabetes for the quantitative measurement of glucose in fresh capillary whole blood samples.

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

• Clever Check TD-4222 No-code Blood Glucose Monitoring System (K090185)

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 k093005

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.) Clever Check TD-4222 No-code Blood Glucose Monitoring System, k090185.
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 the FOR A G72/TD-4264, FOR A G70/TD-4273, Ultra Trak Blood Glucose Monitoring Systems. The changes consisted of software modifications to reduce the memory capacity from 450 to 20 results and the elimination of the PC communication function. The size of the meter has been modified and the weight of the new device is less than that of the predicate.

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