SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM

K130138 · Roche Diagnostics Corp. · NBW · Mar 15, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130138
• Device Name: SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 15, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ACCU-CHEK Inform II Test strip is for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heelstick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples. The ACCU-CHEK Inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. The ACCU-CHEK Inform II Controls are intended for quality control performance checks on the ACCU-CHEK Inform II system with ACCU-CHEK Inform II test strips. The ACCU-CHEK Inform II Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform II system using ACCU-CHEK Inform II test strips.

Device Story

ACCU-CHEK Inform II System is a point-of-care blood glucose monitoring system for professional healthcare settings; used for multiple-patient testing. System components include meter, test strips, control solutions, and linearity test kit. Device measures glucose levels in whole blood samples to aid in monitoring glucose control. This submission specifically validates the use of Super Sani-Cloth wipes for cleaning and disinfecting the device housing and components, ensuring compatibility and effectiveness of disinfection protocols. Healthcare providers use the system to obtain rapid glucose readings, which inform clinical decisions regarding patient glycemic management. The device remains unchanged from its previous clearance (K121679); this notification serves to expand the list of approved cleaning agents.

Clinical Evidence

Bench testing only. Validation performed to confirm that Super Sani-Cloth wipes effectively clean and disinfect the six distinct components of the ACCU-CHEK Inform II System without impacting device performance or material integrity, following the same protocol used for the predicate device.

Technological Characteristics

Glucose dehydrogenase-based electrochemical blood glucose monitoring system. Components include meter, test strips, controls, and linearity kit. No changes to materials, design, or sensing technology from predicate. Validated for use with Super Sani-Cloth (EPA #9480-4) and Clorox Germicidal Wipes (EPA #67619-12) for disinfection.

Indications for Use

Indicated for quantitative glucose measurement in venous, arterial, neonatal heelstick, or fresh capillary whole blood in professional healthcare settings. Not for diabetes diagnosis/screening or neonate cord blood testing.

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 Inform II System (K121679)

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 k130138

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. k121679; ACCU-CHEK Inform II Blood Glucose Monitoring System
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: Modifications to the ACCU-CHEK Inform II Blood Glucose Monitoring System labeling to include validated cleaning and disinfection instructions for the use of an additional disinfectant product (Super Sani-Cloth, EPA #9480-4) with the meter.

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.

Infection Control Studies: The device system is intended for multiple-patient 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 the chosen disinfectant, Super Sani-Cloth, EPA #9480-4. Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 12,045 cleanings and disinfection cycles with the Super Sani-Cloth wipes.

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The robustness studies were designed to simulate 3 years of multiple-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.