REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM

K072489 · Taidoc Technology Corporation · NBW · Sep 20, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072489
• Device Name: REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 20, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The REVOLUTION TD-4229 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 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 the REVOLUTION TD-4229 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Device Story

System measures glucose in fresh capillary whole blood; utilizes electrochemical biosensor technology. Input: capillary blood sample applied to test strip. Processing: electrochemical reaction produces electrical current proportional to glucose concentration; meter calculates blood glucose level. Output: digital display of glucose concentration. Used by healthcare professionals or patients at home for diabetes management. Provides quantitative data to monitor diabetes control program effectiveness. Benefits: enables convenient, frequent self-monitoring of blood glucose levels to assist in glycemic control.

Clinical Evidence

No clinical data provided in the summary document; substantial equivalence determined via bench testing and comparison to predicate device specifications.

Technological Characteristics

Electrochemical glucose test system. Consists of a meter and disposable test strips. Measures glucose via amperometric sensing principle. Standalone device. Battery-powered. No specific materials or software architecture details provided.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from finger and alternative sites (palm, forearm, upper-arm, calf, thigh) in patients with diabetes mellitus. Intended for use by healthcare professionals and patients at home. Contraindicated for neonates and for diagnosis or screening of diabetes mellitus. Alternative site testing restricted to steady-state glucose conditions.

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.

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k072489

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 Revolution TD-4229 Blood Glucose Monitoring System:

1. The name and 510(k) number of TaiDoc Technology Corporation's previously cleared device, Clever Chek TD-4223, cleared under k063212. (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 a change in the mechanical appearance, removal of units in mmol/L option, and for the removal of graphical result indicators for normal, low and high test results.

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.

revised: 8/1/03