ACCU-CHEK ADVANTAGE SYSTEM

K032552 · Roche Diagnostics Corp. · NBW · Sep 12, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032552
• Device Name: ACCU-CHEK ADVANTAGE SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 12, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Accu-Chek Advantage system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary, venous, arterial, and neonate (including cord) blood samples; lay use is limited to capillary whole blood testing.

Device Story

Accu-Chek Advantage System measures glucose concentration in whole blood samples. Input: capillary, venous, arterial, or neonate blood applied to test strips. Principle: amperometric measurement using glucose dehydrogenase enzyme; enzyme converts glucose to gluconolactone, liberating electrons; electrons react with hexacyanoferrate (III) mediator; meter applies voltage to electrodes to re-oxidize reduced mediator; resulting current correlates to glucose concentration. Used in home or clinical settings by patients or healthcare professionals. Output: digital glucose concentration reading. Results assist in diabetes management and clinical decision-making. Code chip provided with test strips ensures meter calibration.

Clinical Evidence

Bench testing only. Validation protocols performed to address hazards identified in the risk analysis (FMEA). No clinical trial data presented.

Technological Characteristics

Blood glucose monitoring system; embedded firmware; modified dimensional and ergonomic specifications. Fundamental scientific technology remains unchanged from predicate.

Indications for Use

Indicated for quantitative glucose measurement in capillary whole blood for persons with diabetes (OTC) or by healthcare professionals (professional use). Professionals may also test venous, arterial, and neonate (including cord) blood. No specific age or gender contraindications listed.

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

• Accu-Chek Advantage System (K032552)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K032552

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I device. The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of ROCHE DIAGNOSTICS CORP.'s previously cleared device, ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM, cleared under K930979. (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 ease of use and increase customer satisfaction. The modifications affect the device's dimensional specifications, ergonomics of user interface, and software/firmware embedded within the device.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, 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.

Comments – Validation Protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FMEA)

revised:3/27/98

December 1, 2005