The Precision Xtra / Optium Blood ß-Ketone Test Strips are intended to quantitatively measure blood ß-Ketone (Beta-Hydroxybutyrate) in fresh capillary whole blood from the fingertip. The test strips are for use outside the body (in vitro diagnostic use) and are for self-testing or healthcare professional use. Healthcare professionals may also use venous whole blood samples, provided the samples are used within 30 minutes of collection. The test strip is to be used for ketone concentrations in persons with diabetes and other conditions.

Device Description

The Precision® Xtra™ Diabetes Monitoring System utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of ß-hydroxybutyrate (ß-ketone) present in the sample, providing a quantitative measure of ß-ketone in whole blood and control solutions.

AI/ML Overview

The Abbott Precision Xtra Blood ß-Ketone Test Strips and Optium Blood ß-Ketone Test Strips are intended for the quantitative measurement of ß-ketone (Beta-Hydroxybutyrate) in fresh capillary whole blood and, for healthcare professionals, in venous whole blood samples within 30 minutes of collection. The device is for in vitro diagnostic use, for self-testing or professional use by individuals with diabetes and other conditions requiring ketone monitoring.

A study was conducted to demonstrate the substantial equivalence of the Precision Xtra Blood ß-Ketone Test Strips/Optium Blood ß-Ketone Test Strips to predicate devices (Precision Xtra Blood ß-Ketone Test Strips K983504 and Optium Blood ß-Ketone Test Strips K040814/K050814).

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that various performance aspects were tested and passed, indicating they met established acceptance criteria, but it does not specify the numerical criteria themselves or the exact reported performance values. The performance studies verified the device through "non clinical testing in the laboratory."

Performance Characteristic	Acceptance Criteria (Implied: Passed)	Reported Device Performance (Implied: Acceptable/Comparable)
Altitude	Met predefined specifications	Verified as acceptable
Dynamic Range	Met predefined specifications	Verified as acceptable
Precision	Met predefined specifications	Verified as acceptable
Linearity	Met predefined specifications	Verified as acceptable
Accuracy	Met predefined specifications	Verified as acceptable
Sample Volume	Met predefined specifications	Verified as acceptable
Interference	Met predefined specifications	Verified as acceptable
Sensor Movement	Met predefined specifications	Verified as acceptable
Oxygen Sensitivity	Met predefined specifications	Verified as acceptable
Sample Application (end/top fill)	Met predefined specifications	Verified as acceptable
Environmental (e.g., temperature/humidity)	Met predefined specifications	Verified as acceptable
Hematocrit	Met predefined specifications	Verified as acceptable
pH	Met predefined specifications	Verified as acceptable
Shipping	Met predefined specifications	Verified as acceptable

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for the non-clinical laboratory testing. The data provenance is stated as "non clinical testing in the laboratory," implying controlled laboratory conditions rather than patient data from a specific country. It is not specified whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided in the document. Given that the testing was "non clinical" and involved laboratory studies, it is unlikely that human experts were involved in establishing ground truth in the way described for clinical studies (e.g., radiologists interpreting images). Ground truth for these types of devices is typically established using a reference method or calibrated laboratory equipment.

4. Adjudication Method for the Test Set:

Not applicable, as this was non-clinical laboratory testing, not a clinical study involving human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The performance studies were non-clinical laboratory tests comparing the device to its predicate devices, not evaluating human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance assessment was effectively done. The performance studies described are for the device (test strips) itself, evaluating its accuracy, precision, and other analytical characteristics in a laboratory setting, without direct human intervention in the result generation process beyond using the device as intended. The "algorithm" here would be the electrochemical reaction and measurement system of the biosensor technology.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth. However, for "non clinical testing in the laboratory" of a quantitative measurement device, the ground truth would typically be established using:

Reference methods: Highly accurate and precise laboratory methods (e.g., enzymatic reference methods for ß-ketone).
Calibrated standards: Solutions with known, precise concentrations of ß-ketone.

8. The Sample Size for the Training Set:

The document does not contain information about a "training set." The mentioned studies are performance verification for the device, implying that the device's design and underlying technology were already established. For this type of in vitro diagnostic device, "training sets" are not typically used in the same manner as for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set is mentioned or implied for this non-clinical performance verification.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Abbott, a healthcare company. The logo consists of a stylized letter 'a' followed by the word 'ABBOTT' in capital letters. The font is a bold, sans-serif typeface, and the color is black against a white background.

K0607688

Ar bott I aboratories

Abnet Diabetes Care Inc.

1160 South Loop Road

Alarmeda. CA 94502

Telephone 510-748-5400
Facsimile 510-864-4770
www.abbottdiabetescare.com

APR 2 1 2006

Attachment 4

510(k) Summary

(as required by 21 CFR 807.92)

Maria E. Trejo Submitted by: Regulatory Affairs Associate Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502 510-749-6384
Date Submitted: March 21, 2006
Device Name: Precision Xtra Blood ß-Ketone Test Strips Optium Blood ß-Ketone Test Strips
Common Name: Blood Ketone Test Strips
Classification: Ketone Test System Class I per 21 CFR 862.1435
Product Code: IIN
Predicate Device: Precision Xtra Blood ß-Ketone Test Strips, K983504 Optium Blood ß-Ketone Test Strips, K040814
The Precision® Xtra™ Diabetes Monitoring System utilizes Description: amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of Bhydroxybutyrate (ß-ketone) present in the sample, providing a quantitative measure of ß-ketone in whole blood and control solutions.
Intended 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

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a ABBOTT

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.

Comparison to

Predicate Device: The Precision Xtra Blood B-Ketone Test Strips/ Optium Blood ß-Ketone Test Strips use the same fundamental scientific technology and have the same intended use as the predicate Precision Xtra Blood ß-Ketone Test Strips (K983504) and Optium Blood ß-Ketone Test Strips (K050814).

Performance

Studies: The performance of the Precision Xtra Blood ß-Ketone Test Strips was verified through non clinical testing in the laboratory. The studies demonstrated that the Precision Xtra Blood ß-Ketone Test Strips/ Optium Blood ß-Ketone Test Strips are substantially equivalent to the current Precision Xtra Blood ß-Ketone Test Strips / Optium Blood ß-Ketone Test Strips for blood ß-ketone measurements.

Conclusion: Results of non clinical testing demonstrate that the performance of the Precision Xtra Blood ß-Ketone Test Strips/ Optium Blood ß-Ketone Test Strips, when used according to the intended use stated above, are acceptable and comparable to the performance of the previously mentioned predicate device for ß-ketone testing.
Test performed and passed were altitude, dynamic range, precision, linearity, accuracy, sample volume, interference, sensor movement, oxygen sensitivity, sample application (end/top fill), environmental, haematocrit, PH and shipping.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three branches extending upwards. The text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Maria E. Trejo Regulatory Affairs Associate Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502

APR 2 1 2006

Re: K060768

Trade/Device Name: Precision Xtra Blood β-Ketone Test Strips Optium Blood B-Ketone Test Strips Regulation Number: 21 CFR8862.1435 Regulation Name: Ketones (nonquantitative) test system Regulatory Class: Class I Product Code: JIN Dated: March 21, 2006 Received: March 22, 2006

Dear Ms. Trejo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Albert Gutt

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ K060768

Device Name: Precision Xtra Blood ß-Ketone Test Strips Optium Blood ß-Ketone Test Strips

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Of cours and in Diam finatuation and b

Page 1 of

Regulation Number and Section

§ 862.1435 Ketones (nonquantitative) test system.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.