FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM

K112275 · Taidoc Technology Corporation · NBW · Dec 15, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112275
• Device Name: FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 15, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The FORA Premium V10 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. 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 glucose 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 single patient; not for visually impaired despite speaking functions. Input: capillary blood sample on test strip; Output: quantitative blood glucose concentration displayed on meter. Modifications from predicate include physical appearance, minor software updates, and transition from RS-232 to USB data transmission. Healthcare provider uses output to assess diabetes control program effectiveness; patient uses results for self-management. Benefits include convenient, accurate, and rapid glucose monitoring.

Clinical Evidence

Bench testing only. System accuracy performance compared against predicate device (FORA V30) demonstrated substantial equivalence. Software verification and validation testing confirmed performance, safety, and effectiveness equivalent to predicate.

Technological Characteristics

Handheld blood glucose meter. Electrochemical sensing principle. USB connectivity. Powered by internal battery. Materials validated for 5,000 cleaning/disinfection cycles. Software-based data processing and storage. Single-patient use design.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from the finger for home use by individuals with diabetes to monitor glycemic control. Not for neonatal use or diabetes screening/diagnosis.

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 V30 blood glucose monitoring system (K093635)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k112275

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.) k093635 FORA V30 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. The name of the device has changed from "FORA V30 Blood Glucose Monitoring System" to "FORA Premium V10 Blood Glucose Monitoring System".

B. The physical appearance of the meter.

C. The data transmission port (from RS232 to USB).

D. The C button is removed.

E. The number of measuring modes is reduced (General, AC PC and QC measuring modes are reduced to General and QC).

F. QC results are not stored in memory.

G. Size and weight changes

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

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.

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This device is intended for single-patient use only. Disinfection efficacy studies were performed by an outside service to evaluate the virus elimination effectiveness of disinfecting wipes in preventing the spread of bloodborne pathogens, particularly hepatitis B virus (HBV). Specifically, Micro-Kill+ cleaner disinfectant towels (with EPA registration # 59894-10-37549) were validated demonstrating complete inactivation of live virus. The sponsor does not market a lancing device for use with the device. The sponsor performed robustness studies and demonstrated that there was no change in performance or in the external materials of the meter after 5,000 cleaning and disinfection cycles designed to simulate 5 years of single patient device use. Labeling has been reviewed for adequate instructions in validated cleaning and disinfection procedures.