ACCU-CHEK INTEGRA SYSTEM

K050872 · Roche Diagnostics Corp. · LFR · May 2, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050872
• Device Name: ACCU-CHEK INTEGRA SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: May 2, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The Accu-Chek Integra system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring glucose 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 and venous blood samples; lay use is limited to capillary whole blood testing. Capillary blood samples can be acquired from fingertips, forearm, upper arm, thigh, calf and palm.

Device Story

Device modification submission for previously cleared Class II/III device (K031755). Modifications include changes to test read time, product packaging, and product name. Fundamental scientific technology remains unchanged. Verification and validation performed via Failure Mode Effects Analysis (FEMA) to assess impact of modifications. Design control activities and declaration of conformity provided to demonstrate that predetermined acceptance criteria were met.

Clinical Evidence

Multi-center performance study conducted to evaluate accuracy and precision. Results demonstrated that the Accu-Chek Integra correlates well with the laboratory plasma glucose reference test method. All predetermined acceptance criteria were satisfied.

Technological Characteristics

Photometric measurement; glucose dye oxidoreductase mediator reaction. Reportable range: 10-600 mg/dL. Hematocrit range: 25-65%. Operating temperature: +10°C to +40°C. Storage temperature: +2°C to +30°C.

Indications for Use

Indicated for persons with diabetes or health care professionals for monitoring glucose levels. Lay users limited to capillary whole blood testing; professionals may test capillary and venous blood. Suitable for alternate site testing (fingertips, forearm, upper arm, thigh, calf, palm).

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

• K031755

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 K050872

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.) k031755
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 test read time, packaging and name of the product.

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

The risk analysis used was the Failure Mode Effects Analysis (FEMA).

revised:8/1/03