DIACHEX BLOOD GLUCOSE MONITORING SYSTEM

K062829 · Tyson Bioresearch, Inc. · NBW · Oct 10, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062829
• Device Name: DIACHEX BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Tyson Bioresearch, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The DIACHEX Blood Glucose Test Strips are used with the DIACHEX Blood Glucose Meter for quantitatively measuring glucose (sugar) in fresh capillary whole blood obtained from the fingertip. The DIACHEX Test Strips are for testing outside the body (in vitro diagnostic use). The DIACHEX Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.

Device Story

Blood glucose meter modification; updates include meter name, physical size, memory capacity, date/time functionality, and 14-day average testing result calculation. Device operates as point-of-care diagnostic tool for glucose monitoring. Modifications verified via design control activities, risk analysis, and performance testing to ensure fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

No clinical data; substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of device modifications.

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme; potassium ferricyanide mediator. Measuring range 20-600 mg/dL. Sample volume ~1.5 uL. Powered by 3V Lithium CR 2032 battery. Meter dimensions 102x52x17 mm; weight 55g. Uses Glucode Chip for calibration.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from the fingertip for diabetes management. Intended for home and professional 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

• K052818

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 K062829

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.) k052818
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 ___ the meter name, the meter size, memory capacity, date/time addition, and inclusion of a 14 days average testing result.

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.

revised:8/1/03