FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM

K132511 · Abbott Diabetes Care, Inc. · NBW · Dec 24, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132511
• Device Name: FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 24, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Freestyle Precision Pro Blood Glucose and β-Ketone Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and from venous, arterial and neonatal whole blood, and for the quantitative measurement of ß-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous, arterial, and neonatal whole blood when used within 30 minutes after collection. The Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, autodisabling lancing devices. The system should not be used for the diagnosis of or screening for diabetes. The Freestyle Precision Pro Blood Glucose Test Strips are for use with the Freestyle Precision Pro Blood Glucose and B-Ketone Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, and from venous, arterial. and neonatal whole blood. The Freestyle Precision Pro Blood B-Ketone Test Strips are for use with the Freestyle Precision Pro Blood Glucose and B-Ketone Meter to quantitatively measure ß-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous, arterial, and neonatal whole blood. Freestyle Precision Pro Blood Glucose and ß-Ketone Monitoring System enables automatic transmission of stored data to a data management system using the docking station (optional). a data upload cable (optional), or wirelessly (optional) in a WiFi enabled facility when the meter and data management systems are properly configured.

Device Story

The FreeStyle Precision Pro is a microprocessor-controlled, handheld blood glucose and beta-ketone monitoring system for professional healthcare use. It accepts fresh capillary, venous, arterial, or neonatal whole blood samples via test strips. The device uses biosensor technology to measure electrical current from the test strip, which is algorithmically processed to compute glucose or ketone concentrations. The meter features an injection-molded plastic case, a graphic LCD for displaying results and menu prompts, and a barcode scanner for lot-specific test strip calibration. It stores up to 2,500 test results, 6,000 Operator IDs, and 1,000 Quality Control tests. Data can be transmitted to management systems via docking station, cable, or WiFi. Healthcare providers use the output to monitor the effectiveness of diabetes control programs. The device benefits patients by providing rapid, quantitative diagnostic information in clinical settings.

Clinical Evidence

Bench testing only. Verification and validation activities performed to assess impact of hematocrit range extension (15-65%). Disinfection efficacy studies confirmed complete inactivation of Hepatitis B Virus (HBV) using Dispatch Hospital Cleaner Disinfectant Towels with Bleach. Robustness testing confirmed no performance degradation after 10,950 cleaning/disinfection cycles.

Technological Characteristics

Microprocessor-controlled meter; injection-molded plastic housing; graphic LCD; barcode scanner for calibration; powered by two AA batteries. Sensing principle: biosensor measuring electrical current from test strips. Connectivity: docking station, data cable, or WiFi. Software: algorithm-based processing of electrical signals.

Indications for Use

Indicated for quantitative measurement of glucose and beta-ketone in fresh capillary, venous, arterial, and neonatal whole blood in professional healthcare settings to monitor diabetes control programs. Not for diagnosis or screening of diabetes.

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 Precision Pro Blood Glucose and β-Ketone Monitoring System (k130094)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k132511

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. (For a preamendments device, a statement to this effect has been provided.) k130094 FreeStyle Pro Blood Glucose and β-ketone 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 extending the hematocrit range for glucose and ketones from 30-60% to 15-65%.

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

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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Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System is intended for multi-patient use. Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial testing lab 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 also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 10,950 cleaning and disinfection cycles, using Dispatch Hospital Cleaner Disinfectant Towels with Bleach, to simulate 3 years of multiple patient use. Labeling has been reviewed for adequate instructions in validated cleaning and disinfection procedures.