ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223

K093592 · Taidoc Technology Corporation · NBW · Feb 25, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093592
• Device Name: ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 25, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The ADVOCATE Redi-Code DUO Blood Glucose plus Blood Pressure Monitoring System is intended for use in the home or clinical setting for the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, forearm, or upper arm and for the non-invasive measurement of systolic and diastolic blood pressure and pulse rate in adults.

Device Story

System combines electrochemical glucose biosensor and oscillometric blood pressure monitor; uses fresh capillary whole blood for glucose; uses wrist-worn inflatable cuff (5.25"-7.75") for blood pressure; operated by healthcare professionals or patients at home; provides quantitative glucose, systolic/diastolic pressure, and pulse rate readings; aids in monitoring diabetes control programs; device includes speaking functions; results used by patients/providers to manage diabetes and blood pressure.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by software verification and validation testing.

Technological Characteristics

Electrochemical biosensor (glucose oxidase) for glucose; oscillometric technology for blood pressure. Includes speaking functions. System components: monitor, test strips, control solutions, lancet device. Software-controlled.

Indications for Use

Indicated for healthcare professionals and patients with diabetes mellitus for quantitative blood glucose monitoring (finger/alternative sites) and non-invasive blood pressure/pulse rate measurement. Contraindicated for neonates, and for diagnosis or screening of diabetes or hypertension. Not intended for visually impaired users despite speaking functions.

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 Duo Blood Glucose Plus Blood Pressure Monitoring System (K070641)

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: k093592

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) for the ADVOCATE Redi-Code DUO Blood Glucose plus Blood Pressure Monitoring System, model TD-3223E:

1. The name and 510(k) number of TaiDoc Technology Corporation's previously cleared device, ADVOCATE Duo Blood Glucose Plus Blood Pressure Monitoring System, cleared under k070641. (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. (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 modifications to the glucose meter portion of the device that includes: 1) a software modification to remove the test strip code selection step and the test strip code number from the display when the test strip is inserted, 2) a software modification to remove the voice readout of the test strip code number, and 3) a change in the physical appearance to remove the code button.

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.