FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247

K090536 · Taidoc Technology Corporation · NBW · Mar 26, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090536
• Device Name: FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 26, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FORA V12 No-Coding 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 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 also includes a speaking functionality to aid visually impaired persons. 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 above systems can be used only during steady-state blood glucose conditions.

Device Story

System measures glucose in fresh capillary whole blood via electrochemical biosensor technology. Input: capillary blood sample applied to test strip. Processing: electrochemical reaction converted to glucose concentration value. Output: digital glucose reading displayed on meter; audio output provided for visually impaired users. Used in home or clinical settings by patients or healthcare professionals. Assists in monitoring diabetes control programs. Does not diagnose diabetes.

Clinical Evidence

No clinical data provided; substantial equivalence based on design control activities, risk analysis, and verification/validation of mechanical modifications.

Technological Characteristics

Electrochemical glucose oxidase biosensor. Handheld meter with LCD display and voice output. Powered by battery. Connectivity: data port for potential PC interface. Sterilization: not applicable (test strips are disposable). Software: embedded firmware for signal processing and glucose calculation.

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

• FORA V10 Blood Glucose Monitoring System (K081560)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K090536

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 Chek TD-4227 Blood Glucose Monitoring System - k072784.
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

1. Change in Mechanical appearance – includes change in shape of buttons.
2. Change in name to FORA V12 No-coding Blood Glucose Monitoring System

Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, reagents, test strips and performance characteristics.

4. 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.

5. 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.