The Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic use for the quantitative measurement of glucose (Dglucose) in fresh capillary whole blood (fingertip), and of B-Ketone (beta hydroxybutyrate) in fresh capillary whole blood samples. The Precision Xceed Pro System is for home (lay user) or professional use. The system is not for use in diagnosing diabetes mellitus, but is to be used as an aid in monitoring the effectiveness of diabetes control programs.

Healthcare professionals may also use the product 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 Description

The Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System (BGKMS) utilizes amperometric biosensor technology to measure glucose and ß-ketone in the sample found in the Precision Xceed Pro test strips to quantitatively measure glucose and Bhydroxybutyrate (B-ketone) concentrations in whole blood samples and Precision, MediSense or Optium Control Solutions.

The Precision Xceed Pro BGKMS measures glucose electrochemically. The glucose biosensor is capable of determining glucose oxidized by the enzyme (Glucose Dehydrogenase, GDH) catalysed reaction with Nicotinamide Adenine Dinucleotide (NAD') cofactor. The reduced form of NAD (NADH) is re-oxidized by reaction with the electrochemical mediator, 1,10-phenanthroline quinone (1,10-PQ). The reduced mediator is re-oxidized via electron transfer at the electrode surface. This current is translated into a number by the monitor, after applying lot specific calibration information and after a 20 second countdown, a concentration value is presented to the user. In this same manner, the biosensor electrode utilizes the enzyme hydroxybutyrate Dehydrogenase (HBDH). which reacts with the ß-hydroxybutyrate (ß-ketone) concentration in the sample. This reaction is transferred to the monitor through an electrical current generated proportional to the level of ß-ketone in the sample. This current is translated into a number by the monitor, after applying lot specific calibration information and after a 10 second countdown, a concentration value is presented to the user.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System (K080960), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text states that the device was tested in accordance with ISO 15197:2003. While specific numerical acceptance criteria (e.g., % within ±15% of reference) are not explicitly detailed in the provided document, the study's conclusion clearly states that the device met these criteria. We can infer the categories of performance assessed.

Performance Metric Category	Acceptance Criteria (Implied by ISO 15197:2003 Compliance)	Reported Device Performance
Dynamic Range	Conforms to ISO 15197:2003 standards for glucose sensing.	Passed
Precision	Conforms to ISO 15197:2003 standards for glucose sensing.	Passed
Linearity	Conforms to ISO 15197:2003 standards for glucose sensing.	Passed
Accuracy	Conforms to ISO 15197:2003 standards. (e.g., typically a certain percentage of results within a defined margin of a reference method)	Passed
Temperature Effects	Conforms to ISO 15197:2003 standards.	Passed
Lay User Acceptability	Demonstrated acceptable for intended lay use.	Passed
Ease of Use	Demonstrated acceptable for intended lay use.	Passed

Note: Specific quantitative acceptance criteria (e.g., 95% of results within ±15 mg/dL or ±15% for glucose values > 100 mg/dL) as defined by ISO 15197:2003 are not provided in this summary. The summary simply states that the device was tested in accordance with the standard and passed.

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

Sample Size:
- "Non-clinical testing": No specific sample size is provided for these laboratory tests (dynamic range, precision, linearity, accuracy, temperature).
- "Clinical fingertip studies": No specific sample size for the clinical studies is provided.
Data Provenance: The document does not explicitly state the country of origin for the data. The manufacturer is based in Alameda, CA, USA, suggesting the studies likely occurred in the USA. The studies were described as "non-clinical testing in the laboratory" and "clinical fingertip studies," indicating they were prospective as they were conducted to evaluate the performance of this specific device.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

The document does not provide information on the number of experts or their qualifications for establishing ground truth. For blood glucose monitoring systems, the "ground truth" (or reference method) is typically established by laboratory-grade analyzers, not human experts in the same way as, for example, image interpretation. The comparison is usually against these standardized laboratory methods.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods like 2+1 or 3+1 are typically used when subjective expert interpretation is involved (e.g., in medical image analysis). For a blood glucose meter, the device's reading is compared directly to a quantitative reference measurement; there's no "adjudication" necessary between experts in this evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

Not applicable. This device is a blood glucose and ß-ketone monitoring system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and the concept of AI assistance for human readers are not relevant.

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

Yes, the primary performance evaluation described is standalone performance. The device itself (Precision Xceed Pro BGKMS) is the "algorithm" in this context, and its readings are directly compared to reference methods. While human users operate the device, the performance being evaluated is the device's ability to accurately measure glucose and ketones, independent of human interpretive judgment. The clinical studies also assessed "lay user acceptability and ease of use," which involves human interaction, but the core accuracy validation is standalone device performance.

7. Type of Ground Truth Used

The ground truth for both glucose and ß-ketone measurements would have been established using laboratory reference methods/analyzers. These are validated, highly accurate methods typically used in clinical laboratories. The document states "The modified blood glucose monitoring system was tested in accordance with ISO 15197:2003," which specifies comparing the device's results to a laboratory reference method.

8. Sample Size for the Training Set

Not applicable. This device is a measurement system based on biosensor technology, not a machine learning model that requires a "training set." Its calibration would involve manufacturing processes and quality control, but not a "training set" in the sense of AI/ML.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this device. Calibration of the device and test strips would rely on precisely prepared reference solutions and standardized analytical methods.

Summary

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K680960

Image /page/0/Picture/1 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "a" on the left, followed by the words "Abbott" and "Diabetes Care" stacked on top of each other on the right. The text is in a bold, sans-serif font.

5 2008 SEP

Abbon Diabetes Care Ina 1360 Senth Loop Road Almoda ( 1 12 12 12 (1) 133 0 19 5219

510(k) Summary (as required by 21 CFR 807.92)

Date Prepared:	April 1, 2008
Company	Abbott Diabetes Care Inc.
Division	Abbott Diabetes Care Inc.
Street Address	1360 South Loop Road
City, State Zip	Alameda, CA 94502
Telephone No.	510-749-5400
Fax No.	510-864-4791
Contact Person:	Maria TrejoRegulatory Affairs AssociateTel No. 510-749-6384Fax No. 510-864-4791maria.trejo@abbott.com
Device Name:	Precision Xceed Pro Blood Glucose and β-KetoneMonitoring System
Common Name:	Blood Glucose Test System
Classification Name:	Glucose Dehydrogenase, Glucose, Class II (21 CFR862.1345)Ketones Test System, Ketones, Class I (21 CFR§862.1435)Product codes NBW, LFR, JIN
Predicate Device:	Precision Xtra Diabetes Monitoring System (K040814)

Description of the Device:

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number by the monitor, after applying lot specific calibration information and after a 20 sccond countdown, a concentration value is presented to the user. In this same manner, the biosensor electrode utilizes the enzyme hydroxybutyrate Dehydrogenase (HBDH). which reacts with the ß-hydroxybutyrate (ß-ketone) concentration in the sample. This reaction is transferred to the monitor through an electrical current generated proportional to the level of ß-ketone in the sample. This current is translated into a number by the monitor, after applying lot specific calibration information and after a 10 second countdown, a concentration value is presented to the user.

Intended Use:

The Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic use for the quantitative measurement of glucose (Dglucose) in fresh capillary, venous, arterial and neonatal whole blood samples, provided the sample is used within 30 minutes, and of ß-Ketone (beta-hydroxybutyrate) in fresh capillary and venous whole blood samples. The Precision Xceed Pro System is for home (lay user) or professional use. The system is not for use in diagnosing diabetes mellitus. but is to be used as an aid in monitoring the effectiveness of diabetes control programs.

Summary of Technological Characteristics:

The Precision Xceed Pro BGKMS has the same fundamental scientific technology and the same intended use as the current on-market Precision™ Xtra System which is based on the same amperometric biosensor technology. The Precision Xceed Pro BGKMS is substantially equivalent to the current predicate device.

Assessment of Non-Clinical Performance Data:

The modified blood glucose monitoring system was tested in accordance with ISO 15197:2003. The performance of the Precision Xceed Pro BGKMS has been verified through non-clinical testing in the laboratory. Testing on dynamic range, precision, linearity, accuracy, and temperature were completed and all passed. These studies demonstrated that the Precision Xceed Pro BGKMS is substantially equivalent to the current Precision Xtra BGMS for blood glucose and B-ketone measurements and is suitable for its intended use.

Assessment of Clinical Performance Data

The modified blood glucose monitoring system was also verified through clinical fingertip studies which were conducted to evaluate the accuracy, lay user acceptability and ease of use of the Precision Xceed Pro System (BGKMS). These studies demonstrated that the Precision Xceed Pro BGKMS is substantially equivalent to the current Precision Xtra BGMS for blood glucose and ß-ketone measurements and is suitable for its intended use.

Conclusion:

Results of non-clinical testing demonstrate that the performance of the Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System, when used according to the intended use stated above, is acceptable and substantially equivalent to the performance of the previously mentioned predicate device for blood glucose testing.

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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 & Human Services. The logo consists of a stylized eagle with its wings spread, and three lines extending from the eagle's body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circle around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

5 2008 SEP

Abbott Diabetes Carc. Inc. c/o Ms. Tammy Wharton Senior Regulatory Affairs Specialist 1360 South Loop Road Alameda, CA 94502

Re: K080960 Trade Name: Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW. LFR. JIN Dated: August 14, 2008 Received: August 15, 2008

Dear Ms. Wharton:

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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Page 2 -

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 s logally 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) 276-0490. 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-freanumber (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean m. Cooper, M.S., D.v.M.

Séan M. Cooper, M.S., D.V.M. 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: K080960

Device Name: Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System

Indications for Use:

The Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic use for the quantitative measurement of glucose (Dglucose) in fresh capillary whole blood (fingertip), and of B-Ketone (beta hydroxybutyrate) in fresh capillary whole blood samples. The Precision Xceed Pro System is for home (lay user) or professional use. The system is not for use in diagnosing diabetes mellitus, but is to be used as an aid in monitoring the effectiveness of diabetes control programs.

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

Over-The-Counter Use X (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) Page 1 of 1

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K080960

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.