GLUCOSE TEST SYSTEM

K113137 · Roche Diagnostics · NBW · Jan 6, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113137
• Device Name: GLUCOSE TEST SYSTEM
• Applicant: Roche Diagnostics
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 6, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The ACCU-CHEK® SmartView Test Strips are for use with the ACCU-CHEK® Nano Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

Device Story

System measures glucose in fresh capillary whole blood (fingertip/palm) via electrochemical test strips. User inserts strip into meter; device applies AC current to detect sample sufficiency; applies AC voltages at four frequencies to assess sample type, temperature, and quality; applies DC voltage to measure glucose-proportional current. AC and DC data combined for hematocrit and temperature-compensated glucose result. Used at home by patients for diabetes management. Meter features embedded strip lot code (no physical code key required). Output displayed on meter screen to inform patient of glucose levels for diabetes control monitoring.

Clinical Evidence

Bench testing only. Validation performed on device durability and performance after 260 cleaning and disinfection cycles using Super Sani-Cloth Germicidal Disposable Wipes to simulate 5 years of single-patient use. No clinical data provided.

Technological Characteristics

Electrochemical glucose monitoring. Dimensions: 69 x 43 x 20 mm. No-coding technology. Validated for chemical compatibility with Super Sani-Cloth Germicidal Disposable Wipes (EPA #9480-4).

Indications for Use

Indicated for single-patient use for blood glucose monitoring.

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

• Roche ACCU-CHEK Aviva Plus Blood Glucose Monitoring System (k101299)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k113137

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. Roche ACCU-CHEK Aviva Plus Blood Glucose Monitoring System – k101299
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
- A change in physical dimensions from 94 x 53 x 22 mm to 69 x 43 x 20 mm (LxWxH)
- A change in ergonomics of user interface (three buttons moved to different locations)
- A change from coding via a code key to no coding required
- A change to the meter name from "Roche ACCU-CHEK Aviva Plus Blood Glucose Monitoring System" to "Roche ACCU-CHEK Nano SmartView Blood Glucose Monitoring System"

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use and 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 – risk analysis method was FMEA.
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.

The device is intended for single patient use only. Super Sani-Cloth Germicidal Disposable Wipe with EPA registration # 9480-4 was validated demonstrating complete inactivation of live virus for use with the meter and lancing device. The sponsor also demonstrated that there was no change in performance or in

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the external materials of the meter and lancing device after 260 cleaning and disinfection cycles designed to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.