Freestyle Freedom Blood Glucose Monitoring Sytem

K152442 · Abbott Laboratories · NBW · Dec 17, 2015 · Clinical Chemistry

Device Facts

• Record ID: K152442
• Device Name: Freestyle Freedom Blood Glucose Monitoring Sytem
• Applicant: Abbott Laboratories
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 17, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Freestyle Freedom Blood Glucose Monitoring System is intended for single-patient use only.

Device Story

The FreeStyle Freedom Blood Glucose Monitoring System is an in vitro diagnostic device for home use by patients with diabetes. It utilizes a blood glucose meter and compatible test strips to quantitatively measure glucose levels in fresh capillary whole blood samples obtained from the finger, upper arm, or palm. The system operates by analyzing the electrochemical reaction between the blood sample and the test strip reagents. The meter displays the glucose concentration, allowing patients to monitor their diabetes management. The device is intended for single-patient use to prevent cross-contamination. Results assist patients and healthcare providers in assessing the effectiveness of diabetes control programs. Alternate site testing is restricted to steady-state conditions when glucose levels are not fluctuating rapidly.

Clinical Evidence

Bench testing only. Disinfection efficacy studies demonstrated complete inactivation of Duck hepatitis B virus (DHBV) using Clorox Healthcare Bleach Germicidal Wipes. Robustness testing confirmed no change in performance or material integrity after 1044 cleaning/disinfection cycles, simulating 5 years of single-patient use.

Technological Characteristics

In vitro diagnostic glucose test system; electrochemical sensing principle; uses disposable test strips for capillary whole blood analysis; handheld meter form factor; intended for single-patient home use.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Review Summary

To: THE FILE

RE: DOCUMENT NUMBER K152442

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): Freestyle Freedom Blood Glucose Monitoring System.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) FreeStyle Blood Glucose Test Strips (K092638)
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:

Incorporating new validated cleaning and disinfection procedures into the labeling of the FreeStyle Freedom Blood Glucose Monitoring System to include: Clorox Healthcare Bleach Germicidal Wipes (67619-12).

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics (including efficacy of cleaning and disinfection agents on the materials of the meter and robustness of the system to repeated cleaning and disinfection).
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

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 Freestyle Freedom Blood Glucose Monitoring system is intended for single-patient use only. Disinfection efficacy studies were performed on materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of Duck hepatitis B virus (DHBV) with the chosen disinfecting agent, Clorox Bleach Germicidal Wipes (EPA Registration #67619-12). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 1044 cleaning and disinfection cycles with Clorox Bleach Germicidal Wipes (EPA Registration #67619-12). The robustness studies were designed to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.