The Precision Xtra / MediSense Optium / Precision Easy / MediSense Optium Easy Blood Glucose Test Strip is intended for outside-of-the-body (in-vitro diagnostic) use. The strip is indicated for the quantitative measurement of glucose in fresh capillary blood for self-testing by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. The test strip is to be used for monitoring blood glucose concentrations in persons with diabetes and other conditions.

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 present in the sample, providing a quantitative measure of glucose in whole blood and control solutions.

AI/ML Overview

The provided text describes a 510(k) submission for Abbott Laboratories' MediSense Optium Plus and Precision Xtra Plus Blood Glucose Test Strips. This submission is for a modified version of an already cleared device, indicating an updated or improved iteration. Therefore, the "acceptance criteria" and "device performance" are framed in the context of demonstrating substantial equivalence to the predicate device rather than meeting specific performance thresholds against a gold standard in a standalone study.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to the predicate device for blood glucose measurement.	"The studies demonstrated that lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements." "Results of laboratory testing demonstrate that the performance of the Precision Xtra Diabetes Test Strip is acceptable and comparable to the performance of the predicate device for blood glucose testing, when used according to its intended use."
Performance for quantitative measurement of glucose in fresh whole blood.	The performance studies were conducted to evaluate the device's ability to quantitatively measure glucose in whole blood. The conclusion states performance is "acceptable and comparable to the predicate device."
Capability for self-testing by lay users.	"The studies demonstrated that lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements." The intended use explicitly states for "self-testing by lay users."
Capability for use by health care professionals.	The intended use explicitly states for "health care professionals." Although the specific statement above focuses on lay users, the overall conclusion of "acceptable and comparable" performance under intended use implies this capability.
Consistency with existing methods for blood glucose measurement.	"The studies demonstrated that lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements." This refers to established clinical blood glucose testing methods, which would serve as the comparator for assessing equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the sample size used for the performance studies.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states that "The performance of the strips using various diabetes monitoring systems was studied in the laboratory."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The concept of "experts" establishing ground truth in the context of blood glucose test strips is not directly applicable in the same way it would be for image analysis or diagnostic decision-making. For these devices, the "ground truth" would typically refer to a reference method of blood glucose measurement (e.g., a laboratory analyzer).
The document does not provide details on specific experts or their qualifications for establishing any reference values. It refers to "current methods for blood glucose measurements" as the comparator.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically used when multiple human readers are interpreting data, and their decisions need to be reconciled. This is not mentioned or relevant for the type of performance study described for blood glucose test strips, which would likely involve direct comparison to a reference analytical method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for blood glucose test strips, which do not involve human "readers" interpreting results in the same way as, for example, radiologists interpreting medical images. The device itself performs the measurement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, performance studies are inherently "standalone" in the sense that the device's analytical performance (how well it measures glucose) is evaluated. The phrase "algorithm only without human-in-the-loop performance" isn't directly applicable as there isn't a complex diagnostic "algorithm" in the AI sense, but rather a chemical reaction and electrochemical detection process. The studies focused on the performance of the strips when used with various diabetes monitoring systems. The core evaluation is the device's ability to produce accurate glucose readings.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth would be established by a reference method for blood glucose measurement, typically a laboratory-grade analyzer (e.g., a YSI analyzer or similar hospital-grade instrument) that is considered highly accurate and precise. The document refers to "current methods for blood glucose measurements" as the benchmark for substantial equivalence.

8. The sample size for the training set

The document does not mention a "training set" in the context of a statistical model or algorithm development. For a chemical-based test strip, "training" isn't typically applicable in this way. The performance studies evaluate the final product.

9. How the ground truth for the training set was established

As there is no mention of a "training set" in the context of algorithm development, this question is not applicable. For quality control and manufacturing, the strips would be tested against known glucose concentrations to ensure they meet specifications, but this is part of manufacturing quality, not a "training set" for an AI algorithm.

Summary

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K051213

Abbott Laboratories Blood Glucose Test Strips MAY 2 7 2005

Special 510(k) May 11, 2005

Attachment 4

510(k) Summary

Per 21 CFR §807.92

Company	Abbott Laboratories
Division	Abbott Diabetes Care
Street Address	1360 South Loop Road
City, State Zip	Alameda, CA 94502
Phone	510-749-6360
Contact Person:	Andrea L. Ruth510-749-6360andrea.ruth@abbott.com
Proprietary Name:	MediSense Optium Plus and Precision Xtra PlusBlood Glucose Test Strips
Common Name:	Blood Glucose Test Strips
Classification Number:	21 CFR §862.1345
Predicate Device:	MediSense Optium Plus and Precision Xtra PlusBlood Glucose Test Strips
Date Prepared:	May 11, 2005

Description of the Device:

Intended Use of the Device:

Blood Glucose Test Strips are intended for in-vitro diagnostic use in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. The test strip is to be used for monitoring blood glucose concentrations in persons with diabetes and other conditions.

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Comparison to Predicate Device:

	Predicate Device	Subject (modified)Device
Company	Abbott Laboratories	Same
Division	Abbott Diabetes Care	Same
510(k) Reference	K023256	Current Submission
Proprietary Name:	MediSense Optium Plus and PrecisionXtra Plus Blood Glucose Test Strips	Same
Common Name:	Blood Glucose Test Strips	Same
Classification Number:	21 CFR §862.1345	Same
Intended Use	Quantitative measurement of bloodglucose concentrations	Same
Single Use?	Yes, test strips are single use	Same
Sterilized?	No	Same

Performance Studies:

The performance of the strips using various diabetes monitoring systems was studied in the laboratory. The studies demonstrated that lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements.

Conclusion:

Results of laboratory testing demonstrate that the performance of the Precision Xtra Diabetes Test Strip is acceptable and comparable to the performance of the predicate device for blood glucose testing, when used according to its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Andrea L. Ruth, RAC Senior Associate, Regulatory Affairs Abbott Laboratories TheraSense, Inc. 1360 South Loop Road Alameda, CA 94502

MAY 2 7 2005

K051213 Re:

KUST213
Trade/Device Name: Optium Plus Blood Glucose Test Strips and Optiali Prava Plus Blood Glucose Test Strips Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LFR, NBW Dated: May 11, 2005 Received: May 17, 2005

Dear Ms. Ruth:

We have reviewed your Section 510(k) premarket notification of intent to market the devices We have reviewed your Section 510(x) prematice is substantially equivalent (for the indications referenced and nave determined the actrice the actives marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices Amendments, o for use stated in the encrosure) to regary manteed pevice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Edgers Food Drug commerce prior to May 28, 1970, the enastinent with the provisions of the Federal Food, Drug, devices that have been recialsmed in accordance will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ap and Cosment Act (Act) that to not require approvince approvisions of the Act. The Act. The Act. The You may, merelore, market the device, baojoer to the go
general controls provisions of the Act include requirements for annual registration, listing of the general controls provisions of the Fectively required of childitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (SCC above) into entirely major regulations affecting your device it may be subject to such additional controls. Blasting may of the only of the subservations of the subject to can be found in Thic 21, Coub of Peachartogan device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualites of a substaints with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA nas made a delemination that your are roo sompler Federal agencies. You must or any Federal statutes and regulations administered of called to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: registr comply with an the Act 3 requirements, intractly); and good manufacturing practice CFR Part 807), labening (21 CFR Parts 601 and 607), and States (QS) regulation (21 CFR Part 820).

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter.

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) This icity wifi anow you to begin mainer of substantial equivalence of your device to a legally premarket nothroation: "The PDF Interlassification 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 of quostions on the prome Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu may other general michinational 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,

Carol C. Benem

Carol C. Benson, M.A. Acting 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): K051213

Optium Plus Blood Glucose Test Strips and Device Name: Precision Xtra Plus Blood Glucose Test Strips

The Precision Xtra / MediSense Optium / Precision Easy / Indications For Use: MediSense Optium Easy Blood Glucose Test Strip is intended for outside-the-body (in-vitro diagnostic) use. The strip is indicated for the quantitative measurement of glucose in fresh capillary blood for self-testing by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. The test strip is to be used for monitoring blood glucose concentrations in persons with diabetes and other conditions.

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)

Rutta Chaber

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Stolk K051213

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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.