MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM

K040814 · Abbott Laboratories · NBW · Apr 15, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040814
• Device Name: MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
• Applicant: Abbott Laboratories
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 15, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Precision Xtra Advanced Diabetes Management System is intended for in vitro diagnostic use (i.e., external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision Xtra is also intended for the quantitative measurement of β-hydroxybutyrate (β-ketone) in fresh capillary whole blood. The Precision Xtra system is indicated for home (lay user) or professional use in the management of Patients with diabetes. The Precision Xtra System may also be used for the quantitative measurement of glucose in venous, arterial, or neonatal whole blood and ketone in venous blood, provided the sample is used within 30 minutes after collection.

Device Story

Precision Xtra Advanced Diabetes Management System uses amperometric biosensor technology to measure glucose or β-hydroxybutyrate (β-ketone) levels. Device accepts fresh capillary, venous, arterial, or neonatal whole blood samples. Biosensor generates electrical current proportional to analyte concentration; system converts current into quantitative blood glucose or ketone result. Used in home or professional clinical settings; operated by patients or healthcare providers. Output displayed to user for diabetes management; informs clinical decisions regarding glycemic control and ketone monitoring.

Clinical Evidence

Performance evaluated in laboratory and clinical settings by healthcare professionals and lay users. Studies demonstrated that lay users obtain blood glucose and β-ketone results substantially equivalent to current measurement methods.

Technological Characteristics

Blood glucose meter; fundamental scientific technology unchanged from predicate. Modification involves name change and test strip compatibility.

Indications for Use

Indicated for patients with diabetes (lay users or professionals) for quantitative measurement of glucose and β-hydroxybutyrate (β-ketone) in fresh capillary whole blood. Also indicated for glucose measurement in venous, arterial, or neonatal whole blood and ketone measurement in venous blood.

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

• Precision Xtra™ Advanced Diabetes Management System (K983504)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K040814

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.)
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 changing the name from the Precision Xceed meter to the Precision Xtra meter and for the use of a strip on the meter that was previously cleared on a former version of the meter.

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.