For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the BREEZE 2 Blood Glucose Monitor.

Device Description

The FDTX Glucose Control Solution consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is non-hazardous and contains no human or animal derived materials.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the FDTX Glucose Control Solution based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a dedicated table format with corresponding reported performance values for each criterion. Instead, it outlines the general characteristics of the device and compares them to predicate devices, and then lists the types of performance studies conducted. The implication is that the performance of the FDTX Glucose Control Solution was found to be comparable or acceptable relative to the predicate devices and industry standards for these types of control solutions.

Acceptance Criteria Category/Characteristic	Reported Device Performance (as implied by comparison to predicates and study types)
Intended Use	For in vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Bayer Ascensia BREEZE 2 Blood Glucose Monitor. (Matches predicate's function for a specific glucose monitor).
Levels of Control	1 level of control (Matches predicate devices).
Analyte	Glucose (Matches predicate devices).
Target (mg/dL)	100 mg/dL (Matches predicate devices).
Target Range (mg/dL)	85 - 130 mg/dL (Matches Predicate Device No. 1, different from Predicate Device No. 2, but likely within acceptable range for the intended use and specific meter).
Container	Plastic bottle with dropper-tip (Matches predicate devices).
Fill Volume	3.6 mL (Matches Predicate Device No. 2, different from Predicate Device No. 1, but likely acceptable).
Color	Red (Matches Predicate Device No. 2, different from Predicate Device No. 1, but this is a visual aid and not a performance criterion).
Matrix	Buffered aqueous solution of D-Glucose, a viscosity modifier, preservatives, and other non-reactive ingredients (Similar to predicate device composition).
Stability	"Tests were performed to verify specific performance characteristics: Stability." (Implies satisfactory stability was demonstrated, though no specific numerical acceptance range or duration is provided).
Open Vial Stability	"Tests were performed to verify specific performance characteristics: Open Vial." (Implies satisfactory open-vial stability was demonstrated, though no specific numerical acceptance range or duration is provided).
Test Precision	"Tests were performed to verify specific performance characteristics: Test precision." (Implies satisfactory precision was demonstrated, though no specific numerical acceptance limits or results are provided).

2. Sample size used for the test set and the data provenance:

The document does not specify the sample size used for the test set (number of measurements, number of vials, etc.) for stability, open vial, or precision studies.
The document does not specify the data provenance (e.g., country of origin, retrospective or prospective). Given the context of a 510(k) submission for a control solution, these studies would typically be prospective and conducted internally by the manufacturer, but this is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided for this device. The device is a "Glucose Control Solution," which is a diagnostic reagent used to verify the performance of a blood glucose monitor. Ground truth for such a control solution is established by its manufactured concentration and subsequent assay/calibration against reference methods, not by expert interpretation. Experts are not directly involved in establishing the "ground truth" of the control solution itself.

4. Adjudication method for the test set:

This information is not applicable and not provided. As explained above, expert adjudication is not relevant for establishing the "ground truth" or performance of a glucose control solution.

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:

This information is not applicable. The device is a glucose control solution, not an AI-powered diagnostic tool, and involves no human interpretation of medical images or data that would necessitate an MRMC study.

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

This information is not applicable. The device is a physical control solution, not an algorithm, so the concept of standalone algorithmic performance doesn't apply.

7. The type of ground truth used:

The ground truth for a glucose control solution is the known, manufactured, and independently verified concentration of glucose within the solution, established through rigorous chemical assays and calibration against reference standards. The document states the solution contains a "known quantity of glucose" and has a "Target (mg/dL)" of 100. This known concentration serves as the ground truth.

8. The sample size for the training set:

This information is not applicable and not provided. This device is not an AI algorithm that requires a "training set" in the conventional sense. The development of such a control solution involves chemical formulation, analytical testing, and process validation, not machine learning model training.

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

This information is not applicable. As stated above, there is no "training set" for this type of device. The ground truth (known glucose concentration) for the product itself is established through chemical manufacturing and analytical testing procedures.

Summary

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K080273

5. 510(k) Summary

AUG - 8 2008

Introduction:	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter:	Fujirebio Diagnostics Texas Inc.940 Crossroads BlvdSeguin, TX 78155(830) 372-1391 ex. 210Establishment Registration Number: 1643621
Contact Person:	John C. Gormley
Device Name:	FDTX Glucose Control Solution
Common Name:	Single Analyte Control Solution, All Types (Assayed and Unassayed)
Classification Name:	Quality Control Material (assayed and unassayed).
Classification:	Class I per 21 CFR 862.1660
Product Code:	75 JJX
Panel:	Chemistry
Predicate Devices:	Name:Bayer Ascensia BREEZE 2 Normal ControlManufacturer:Bayer Healthcare, LLC.510(k) No.:K062347Name:Liberty Normal Glucose Control SolutionManufacturer:Liberty Healthcare Group510(k) No.:K060426	Name:	Bayer Ascensia BREEZE 2 Normal Control	Manufacturer:	Bayer Healthcare, LLC.	510(k) No.:	K062347	Name:	Liberty Normal Glucose Control Solution	Manufacturer:	Liberty Healthcare Group	510(k) No.:	K060426
Name:	Bayer Ascensia BREEZE 2 Normal Control
Manufacturer:	Bayer Healthcare, LLC.
510(k) No.:	K062347
Name:	Liberty Normal Glucose Control Solution
Manufacturer:	Liberty Healthcare Group
510(k) No.:	K060426
Device Description:	The FDTX Glucose Control Solution consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is non-

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hazardous and contains no human or animal derived materials.

The FDTX Glucose Control Solution is intended for in Intended Use: vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of Bayer Ascensia BREEZE 2 Blood Glucose Monitor.

Comparison to Predicate Device:

Characteristic/Aspect	Predicate Device No. 1	Predicate Device No. 2	New Product
Name	Ascensia BREEZE 2Control Normal	Liberty Glucose NormalControl Solution	FDTX Glucose ControlSolution
510(k), Date	K062347, 11/21/2006	K060426, 3/09/2006	K080273
Number ofLevels	1	1	1
Analyte	Glucose	Glucose	Glucose
Target (mg/dL)	100	100	100
Target Range(mg/dL)	85 - 130	113 - 170	85 - 130
Container	Plastic bottle withdropper-tip	Plastic bottle withdropper-tip	Plastic bottle withdropper-tip
Fill Volume	2.5 mL	3.6 mL	3.6 mL
Color	Blue	Red	Red
Matrix	Blue solutioncontaining a measuredamount of glucose.	Buffered aqueoussolution of D-Glucose, aviscosity modifier,preservatives, and othernon-reactive ingredients	Buffered aqueoussolution of D-Glucose, aviscosity modifier,preservatives, and othernon-reactive ingredients
Indications forUse	For use as qualitycontrol check to verifythat the BREEZE 2meter and test stripsare working properly.	To check theperformance of the BayerAscensia DEX 2/DEXand BREEZE BloodGlucose Monitors.	To check theperformance of the BayerAscensia BREEZE 2 BloodGlucose Monitor.
TargetPopulation	Professional and homeuse	Professional and homeuse	Professional and homeuse

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Performance Studies: Tests were performed to verify specific performance characteristics:

1. Stability
1. Open Vial
1. Test precision

Conclusion: Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Fujirebio Diagnostics Texas, Inc c/o Mr. John Gormley, Director of Quality & Regulatory Affairs 940 Crossroads Boulevard Seguin, TX 78155

AUG - 8 2008

Re: K080273 Trade/Device Name: FDTX Glucose Control Solution Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I , reserved Product Code: JJX Dated: June 17, 2008 Received: June 17, 2008

Dear Mr. Gormley:

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 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) 276-0490. 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-free number (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.

Jean 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 Statement 4.

510(k) Number (if known): K080273

FDTX Glucose Control Solution Device Name:

Indications for Use:

For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the BREEZE 2 Blood Glucose Monitor.

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

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

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K080273

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.