ASCENSIA ELITE DIABETES CARE SYSTEM

K043311 · Bayer Healthcare, LLC · NBW · Dec 22, 2004 · Clinical Chemistry

Device Facts

• Record ID: K043311
• Device Name: ASCENSIA ELITE DIABETES CARE SYSTEM
• Applicant: Bayer Healthcare, LLC
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The Ascensia ELITE™ Diabetes Care System is for the Self-Monitoring of Blood Glucose as an adjunct to the care of person with diabetes. 4

Device Story

The Ascensia ELITE™ Diabetes Care System is a blood glucose monitoring device used by patients and healthcare professionals. It utilizes an electrochemical meter and dry reagent test strips. Capillary action draws a small whole blood sample into the test strip reaction chamber. The meter processes the electrochemical signal to quantify glucose levels, displaying results in 30 seconds. The system is used for self-monitoring of blood glucose as an adjunct to diabetes management. Results are referenced to plasma glucose. The device provides quantitative data to assist patients and clinicians in making diabetes care decisions.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control procedures; results met predetermined acceptance criteria.

Technological Characteristics

Microprocessor-based blood glucose meter; fundamental scientific technology unchanged from predicate; design controls per 21 CFR 820.30.

Indications for Use

Indicated for use by patients with diabetes for the quantitative measurement of glucose in capillary whole blood.

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

• Ascensia ELITE™ Blood Glucose Meter (K020208/K964630)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K043311

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 pre-amendments device, a statement to this effect has been provided.)
Ascensia ELITE Blood Glucose Meter (k020208 and k964630)

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.
The modification was a change to the microprocessor.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and a description of protocols used and specifications applied.

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.

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.