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 ß-hydroxybutyrate (ßketone) 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 Description

The Precision Xtra™ Advanced Diabetes Management System utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose or β-hydroxybutytate (β-ketone) present in the sample, providing a quantitative measure of glucose or β-ketone in whole blood and control solutions.

AI/ML Overview

The provided text describes the Precision Xtra™ Advanced Diabetes Management System and its 510(k) summary, but it does not contain the specific acceptance criteria or detailed study results that would allow for the completion of the requested table and comprehensive study description.

The document primarily focuses on the device's intended use, classification, comparison to a predicate device, and a general statement about performance studies. It states that "The studies demonstrated that lay users can obtain blood glucose and blood β-Ketone results that are substantially equivalent to the current methods for blood glucose and blood β-ketone measurements," but does not provide the acceptance criteria or the reported performance metrics (e.g., accuracy, precision, bias).

Therefore, I cannot fully complete the requested information based only on the provided text. I will indicate where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance (as stated in the document)
Blood Glucose	Specific criteria not provided in the document	"lay users can obtain blood glucose... results that are substantially equivalent to the current methods for blood glucose... measurements."
Blood β-Ketone	Specific criteria not provided in the document	"lay users can obtain... blood β-Ketone results that are substantially equivalent to the current methods for... blood β-ketone measurements."
Overall Performance	Specific criteria not provided in the document	"acceptable and comparable to the performance of the previously mentioned predicate device for blood glucose and blood β-ketone testing."

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

Sample size for test set: Not specified in the provided document.
Data provenance: Not explicitly stated (e.g., country of origin). The studies were conducted "in the laboratory and in clinical settings by healthcare professionals and lay users," which suggests a prospective clinical study component.

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

Number of experts: Not specified beyond "healthcare professionals" being involved in clinical settings.
Qualifications of experts: Not specified (e.g., specific medical titles, years of experience). The document generally refers to "healthcare professionals."

4. Adjudication Method for the Test Set

Adjudication method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC study: Not explicitly mentioned as an MRMC comparative effectiveness study. The document states that "lay users can obtain blood glucose and blood β-Ketone results that are substantially equivalent to the current methods," which implies a comparison with existing methods, but not necessarily an MRMC study format examining human reading improvement with AI assistance. This device is a blood glucose/ketone meter, not an imaging AI device that assists human readers.

6. Standalone Performance Study

Standalone performance study: The document states, "The performance of the Precision Xtra Diabetes Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users." This indicates that the device's performance was evaluated independently, without requiring human-in-the-loop assistance for its operation and result generation. The statement "lay users can obtain blood glucose and blood β-Ketone results" further supports that the device performs its intended function to provide results on its own.

7. Type of Ground Truth Used

Type of ground truth: Not explicitly stated, but for glucose and ketone measurements, the ground truth would typically be established by a laboratory reference method (e.g., a laboratory analyzer considered the gold standard for glucose and β-ketone levels). The phrase "substantially equivalent to the current methods" suggests comparison to such reference methods.

8. Sample Size for the Training Set

Sample size for training set: This device, being an amperometric biosensor, does not typically use a "training set" in the machine learning sense. Its performance is based on its electrochemical design and calibration. Therefore, this question is not applicable in the context of this type of medical device.

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

Ground truth for training set: As mentioned above, this question is not applicable as the device's mechanism does not involve a "training set" for an AI algorithm. Its calibration would be established against known concentrations of glucose and β-ketone using reference methods.

Summary

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K040814

APR 1 5 2004

(MediSense

510(k) Summary

(as required by 21 CFR 807.92)

Submitted by:	Tracey H. Wielinski RACStrategic Quality Assurance and Regulatory Affairs ManagerAbbott Laboratories, MediSense Products4A Crosby DriveBedford, MA 01730
Device Name:	Precision Xtra™ Advanced Diabetes Management System
Common Name:	Whole Blood Glucose and Ketone Test System
Classification:	Glucose Test SystemClass II per 21 CFR 862.1345
	Ketone Test SystemClass I per 21 CFR 862.1435
Product Code:	NBW, LFR, JIN
Predicate Device:	Precision Xtra™ Advanced Diabetes Management System, K983504
Description:	The Precision Xtra™ Advanced Diabetes Management System utilizesamperometric biosensor technology to generate a current. The size of thecurrent is proportional to the amount of glucose or β-hydroxybutytate (β-ketone) present in the sample, providing a quantitative measure ofglucose or β-ketone in whole blood and control solutions.
	Indications for Use: The Precision Xtra Advanced Diabetes Management System is intendedfor in vitro diagnostic use (i.e., external use only) for the quantitativemeasurement of glucose in fresh capillary whole blood. The PrecisionXtra is also intended for the quantitative measurement of β-hydroxybutyrate (β-ketone) in fresh capillary whole blood. The PrecisionXtra system is indicated for home (lay user) or professional use in themanagement of Patients with diabetes.
	The Precision Xtra System may also be used for the quantitativemeasurement of glucose in venous, arterial, or neonatal whole blood andketone in venous blood, provided the sample is used within 30 minutesafter collection.

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Comparison toPredicate Device:	The modified Precision Xtra™ Advanced Diabetes Monitoring Systemuses the same fundamental scientific technology and has the sameintended use as the predicate Precision Xtra Advanced DiabetesManagement System (K983504).
PerformanceStudies:	The performance of the Precision Xtra Diabetes Monitoring System wasstudied in the laboratory and in clinical settings by healthcareprofessionals and lay users. The studies demonstrated that lay users canobtain blood glucose and blood β-Ketone results that are substantiallyequivalent to the current methods for blood glucose and blood β-ketonemeasurements.
Conclusion:	Results of laboratory and clinical testing demonstrate that theperformance of the Precision Xtra Diabetes Monitoring System, whenused according to the intended use stated above, is acceptable andcomparable to the performance of the previously mentioned predicatedevice for blood glucose and blood β-ketone testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

APR1 5 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Tracey H. Wielinski, RAC Strategic Quality Assurance and Regulatory Affairs Manager Abbott Laboratories MediSense Products 4-A Crosby Drive Bedford, MA 01730

K040814 Re:

Trade/Device Name: Precision Xtra™ Advanced Diabetes Management System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR, JIN Dated: March 29, 2004 Received: March 30, 2004

Dear Ms. Wielinski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalcnt (for the indications for use stated in the enclosurc) to legally marketed predicate devices marketed in interstatc 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 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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Seain M. Cooper, US, DVM.

Jean M. Cooper, MS, 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 (if known):

Device Name:

Precision Xtra " Advanced Diabetes Management System

Indications For Use:

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

Over-The-Counter Use X (21 CFR 807 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)

Carol Benn
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040814

Page 1 of __ 1

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.