FreeStyle InsuLinx Blood Glucose Monotioring System

K152328 · Abott Laboratories · LFR · Sep 17, 2015 · Clinical Chemistry

Device Facts

• Record ID: K152328
• Device Name: FreeStyle InsuLinx Blood Glucose Monotioring System
• Applicant: Abott Laboratories
• Product Code: LFR · Clinical Chemistry
• Decision Date: Sep 17, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples for a single person.

Device Story

The FreeStyle InsuLinx System is a personal blood glucose monitoring device for home use by patients with diabetes. It utilizes a meter and test strips based on coulometric biosensor technology; the device measures glucose via an electrochemical reaction with glucose dehydrogenase (GDH) on the test strip. The meter detects blood application, performs the assay, and displays the result. It features a touch screen, customizable audible/visual reminders, and an integrated logbook. The system includes 'plug and play' software (FreeStyle Auto-Assist) that installs via USB to a PC for data management and report generation. The device is intended for single-patient use. The current modification updates the lancing device to the FreeStyle Lancing Device II and updates the validated cleaning/disinfection protocols using Clorox Healthcare Bleach Germicidal Wipes.

Clinical Evidence

Bench testing only. Robustness studies performed for 522 cleaning/disinfection cycles to verify device functionality and material integrity. Disinfection efficacy testing validated complete inactivation of duck hepatitis B virus (HBV) using Clorox Healthcare Bleach Germicidal Wipes.

Technological Characteristics

Coulometric biosensor technology; GDH-FAD enzyme; 0.3 µL sample volume; 5-second measurement time; 20-500 mg/dL range; USB connectivity for data management; no coding required; validated for 522 cleaning/disinfection cycles (meter) and 210 cycles (lancing device) using Clorox Healthcare Bleach Germicidal Wipes.

Indications for Use

Indicated for single-person use for quantitative measurement of glucose in fresh capillary whole blood samples.

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 (k120568)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER: k153238

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, FreeStyle InsuLinx Blood Glucose Monitoring System (k120568). 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).

2. 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 changing the wipes used for cleaning and disinfection from Dispatch hospital cleaner disinfectant towels with bleach, EPA # 56392-8 to Clorox healthcare bleach germicidal wipes, EPA #67619-2.

3. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance characteristics. Studies performed include disinfection robustness testing to verify that the meter meets the acceptance criteria which is to pass the tests to stay functional after cleaning and disinfecting. In addition, disinfection efficacy testing was done to ensure that the meter meets the disinfection requirements.

4. 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.

The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples for a single person. Disinfection efficacy of the Clorox Healthcare Bleach Germicidal Wipes (EPA #67619-12) was validated using materials from the meters demonstrating complete inactivation of duck hepatitis B virus (HBV). The sponsor also performed robustness studies demonstrating that there was no change in performance or in the materials of the FreeStyle InsuLinx Blood Glucose Monitoring System after 522 cleaning and 522 disinfection cycles (1 cycle per week for 5 years) designed to simulate five years use life of the device. The labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.