ACCU-CHEK AVIVA PLUS TEST STRIP

K131029 · Roche Diagnostics Operations, Inc. · NBW · Aug 9, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131029
• Device Name: ACCU-CHEK AVIVA PLUS TEST STRIP
• Applicant: Roche Diagnostics Operations, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 9, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Accu-Chek Aviva Plus System and Accu-Chek Aviva Combo System are intended for the quantitative measurement of glucose in fresh capillary whole blood samples from the finger, palm, forearm, or upper arm. The systems are intended for use by a single person and should not be shared. The systems are intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The systems are not intended for the diagnosis of or screening for diabetes mellitus, nor for use on neonates.

Device Story

System comprises blood glucose meter, test strips, control solutions, and insulin infusion pump. Meter accepts fresh capillary whole blood samples; uses electrochemical test strips to quantify glucose levels. Modified Black Code Key provides universal coding for test strip lots. Meter interfaces with insulin pump via radio frequency for remote control and dose calculation based on user-entered data. Used at home by patients for diabetes management. Output displayed on meter screen; informs insulin dosing and diabetes control monitoring. Benefits include integrated glucose monitoring and insulin delivery control.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to confirm that the universal calibration key modification meets predetermined acceptance criteria.

Technological Characteristics

System includes glucose meter, test strips, and insulin pump. Uses electrochemical sensing for glucose measurement. Features radio frequency connectivity for meter-to-pump communication. Includes Black Code Key for universal test strip lot coding.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (finger, palm, forearm, upper arm) for single-patient self-testing by individuals with diabetes to monitor glycemic control. Not for neonatal use or diabetes diagnosis/screening.

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 Aviva Plus System (K101299)
• Accu-Chek Aviva Combo System (K111353)

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 K131029

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 Roche Diagnostic's previously cleared devices, the Accu-Chek Aviva Plus System cleared under k101299 and the Accu-Chek Aviva Combo System cleared under k111353.
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 switching from lot specific white calibration code key to black universal calibration code keys that will work with all test strip lots.

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.