PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS

K060768 · Abbott Diabetes Care, Inc. · JIN · Apr 21, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060768
• Device Name: PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: JIN · Clinical Chemistry
• Decision Date: Apr 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1435
• Device Class: Class 1

Indications for Use

The Precision Xtra Blood β-Ketone Test Strips are intended for in vitro diagnostic use (i.e., external use only) for the quantitative measurement of ß-hydroxybutyrate (ß-ketone) in fresh capillary whole blood. The Precision Xtra Blood ß-Ketone Test Strips are indicated for home (lay user) or professional use. Healthcare professionals may also use venous whole blood samples, provided the samples are used within 30 minutes of collection.

Device Story

Precision Xtra/Optium Blood ß-Ketone Test Strips utilize amperometric biosensor technology; device measures current proportional to ß-hydroxybutyrate concentration in blood samples. Used by lay users for home self-testing or by healthcare professionals in clinical settings. Input consists of fresh capillary whole blood (or venous blood for professionals); output is quantitative ß-ketone concentration. Provides rapid metabolic status assessment for patients with diabetes or other conditions; aids clinical decision-making regarding ketone management.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements; results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

Hydroxybutyrate dehydrogenase chemistry; test strip form factor; end/top fill mechanism; 0.5ul sample volume; 10-second test time.

Indications for Use

Indicated for the quantitative determination of hydroxybutyrate in whole blood.

Regulatory Classification

Identification

A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.

Predicate Devices

• k983504
• k050814

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k060768

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.) k983504 and k050814
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.

The modification to the test strips include – Shortened test time from 30 seconds to 10 seconds by reconfiguring the test strip, smaller sample size (1.5ul to 0.5ul), Strip color (from white to lilac) and Fill type (from a top fill to a end fill/top fill allowing sample to be added to the top end of the strip as opposed to the top of the strip).

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