ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276

K093940 · Taidoc Technology Corporation · NBW · Apr 23, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093940
• Device Name: ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 23, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The ADVOCATE REDICODE Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. It is intended for use by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

System measures glucose in fresh capillary whole blood via electrochemical biosensor (glucose oxidase). Components include meter, test strips, control solution, and lancing device. Used by healthcare professionals or patients at home for monitoring diabetes control. User applies blood sample to test strip; meter performs electrochemical analysis; result displayed on screen. Provides quantitative glucose values to assist in diabetes management. Modifications from predicate include software changes, removal of ketone warning, physical appearance updates, memory capacity changes, and removal of data transmission function.

Clinical Evidence

Bench testing only. Software verification and validation testing confirmed performance, safety, and effectiveness equivalent to the predicate device.

Technological Characteristics

Electrochemical biosensor using glucose oxidase. System includes meter, test strips, control solution, and lancing device. Modifications include software, memory capacity, and physical design changes. No specific ASTM standards or connectivity protocols listed.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from the finger; intended for home use by patients with diabetes to monitor glycemic control; not for diabetes diagnosis, screening, or neonatal use.

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

• ADVOCATE REDICODE Blood Glucose Monitoring System, Model TD-4223F (K072039)

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 k093940

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. k072039 (ADVOCATE REDICODE Blood Glucose Monitoring System, Model TD-4223F).
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:

Software modification to include two additional measuring modes (no food intake for at least 8 hours and 2 hours after meal), removal of ketone warning, physical appearance change to the meter and test strips, reduced memory capacity, minor engineering changes in PCBA and circuit board, battery type change, and removal of data transmission function.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and sample type. Studies include software validation, accuracy and precision testing, mechanical resistance to drop and vibration, evaluation of the effects of temperature and humidity, and user study evaluation.
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.