FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM

K120568 · Abbott Diabetes Care, Inc. · NBW · Mar 29, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120568
• Device Name: FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 29, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The FreeStyle InsuLinx 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 FreeStyle InsuLinx Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

Device Story

System uses coulometric biosensor technology to measure glucose in capillary whole blood. Meter reacts glucose with Glucose Dehydrogenase (GDH) on test strip; electrochemical mediation generates electrical current proportional to glucose concentration. Device features touch screen, automated logbook, and 'plug and play' software for PC-based reporting. Patients/HCPs set reminders and target ranges. Software generates reports (Snapshot, Modal Day, Logbook, Statistics, Meal Averages) to facilitate therapy management. Used by patients at home for self-monitoring; data reviewed by HCPs to assess diabetes control. Modification adds lancing device and lancets to kit.

Clinical Evidence

No clinical data presented. Substantial equivalence established via bench testing and comparison of technical specifications to the predicate device.

Technological Characteristics

Coulometric biosensor; GDH-FAD enzyme; 0.3 µL sample volume; 5-second measurement time; 20-500 mg/dL range; 15-65% hematocrit range. Connectivity via USB. No coding required. Software resides on meter.

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

• FreeStyle InsuLinx Blood Glucose Monitoring System (k111874)

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: k120568

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) for the FreeStyle InsuLinx Blood Glucose Monitoring System:

1. The name and 510(k) number of SUBMITTER'S previously cleared device: FreeStyle InsuLinx Blood Glucose Monitoring System, cleared under k111874

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 FreeStyle InsuLinx Blood Glucose Monitoring System labeling to include validated cleaning and disinfection instructions for the FreeStyle Lancing Device.

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.

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.

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The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for single-patient use only. Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by an outside commercial testing facility demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Dispatch Hospital Cleaner Disinfectant Towels with Bleach (EPA Reg. No: 56392-8). Robustness studies were performed by the sponsor demonstrating that there was no change in performance or external materials for the meter and lancing device after 522 cleanings and 522 disinfection steps with Dispatch Hospital Cleaner Disinfectant Towels. The robustness studies were designed to simulate cleaning and disinfection once per week over 5 years. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.