FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM

K070850 · Abbott Diabetes Care, Inc. · NBW · Apr 10, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070850
• Device Name: FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 10, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FreeStyle Lite Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand. The FreeStyle Lite Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

Device Story

FreeStyle Lite Blood Glucose Monitoring System (BGMS) uses coulometric biosensor technology to measure glucose concentration in whole blood. Device employs glucose dehydrogenase (GDH) enzyme on test strips to recognize glucose; electrochemical measurement occurs via coulometry. System designed for use by healthcare professionals and patients at home to monitor diabetes control programs. Input is whole blood sample (0.3 microliter); output is quantitative glucose concentration (mg/dL) displayed on monitor. Key features include 400-result memory and 7-, 14-, and 30-day averages. Device eliminates manual calibration code entry required by predicate. Powered by 3V coin cell battery; includes serial port for communication. Provides patients with actionable data for diabetes management.

Clinical Evidence

Bench testing only; design control activities and verification/validation testing performed to confirm that modifications met predetermined acceptance criteria; no clinical data provided.

Technological Characteristics

Electrochemical glucose monitoring system; features backlight and test light; includes 7 and 30-day moving average calculation capability; increased data storage; no-code calibration; fundamental sensing technology consistent with predicate.

Indications for Use

Indicated for quantitative glucose measurement in whole blood for patients with diabetes mellitus. Suitable for use by healthcare professionals and patients at home. Sites include finger, forearm, upper arm, thigh, calf, and hand. Contraindicated for neonates and arterial 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 Freedom™ Blood Glucose Monitoring System (K051839)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k070850

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM:

1. The name and 510(k) number of ABBOTT DIABETES CARE INC.'s previously cleared device, FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTE, cleared under k051839. (For a preamendments device, a statement to this effect has been provided.)
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.
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 slightly smaller dimensions, addition backlight and test light, of 7 and 30 day moving averages, larger test storage, and no manual calibration code entry.
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.