AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION

K121654 · I-Sens, Inc. · CGA · Sep 5, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121654
• Device Name: AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION
• Applicant: I-Sens, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Sep 5, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The i-SENS Auto-Chek Blood Glucose Monitoring System is intended for single patient home use.

Device Story

Blood glucose monitoring system; intended for single-patient home use. Device measures glucose levels in capillary whole blood. Modification includes changes to meter housing shape, test strip electric connector pattern, and brand name. System comprises meter, test strips, and control solution. Operates via electrochemical biosensor technology; consistent with predicate. User performs fingerstick, applies blood to test strip, and meter displays glucose concentration. Cleaning/disinfection validation performed using Clorox Germicidal Wipes to ensure material robustness over 520 cycles, simulating 5 years of use.

Clinical Evidence

Bench testing only. Validation focused on verifying that the modified electric connector pattern did not affect device safety or performance. Disinfection studies using CLOROX GERMICIDAL Wipes demonstrated complete inactivation of Hepatitis B virus and confirmed material robustness over 260 cleaning cycles, simulating 5 years of use.

Technological Characteristics

Electrochemical biosensor blood glucose monitoring system. Modifications: updated meter housing geometry and test strip electrical connector pattern. Validated for 520 cleaning/disinfection cycles using EPA-registered Clorox Germicidal Wipes. System includes meter, test strips, and control solution.

Indications for Use

Indicated for single patient home use for the monitoring of blood glucose levels.

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

• COOL Blood Glucose Monitoring System (k103396)

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: k121654

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 for the i-SENS AUTO-CHEK Blood Glucose Monitoring System:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
i-SENS, Inc., COOL Blood Glucose Monitoring System (k103396)

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:

1) The shape of meter's housing
2) The electric connector pattern of the test strip
3) The brand name of the meter, the test strip, the control solution and the blood glucose monitoring system.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and cleaning and disinfection robustness study.

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.

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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 i-SENS Auto-Chek Blood Glucose Monitoring System is intended for single patient home use. Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with Clorox® Germicidal Wipes (EPA Reg. No: 67619-12). The sponsor has demonstrated that there is no change in performance or in the external materials of the meter and lancing device after 520 pre-cleaning/disinfection cycles (each pre-cleaning/disinfection cycle includes 1 pre-cleaning and 1 disinfection wipe, adding up to a total of 520 wipes) designed to simulate 5 years of device use. Labeling has been reviewed for adequate instructions for validated cleaning and disinfection procedures.