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 TrueTrack®, TrackEASE® and TRUEread™ meters and test strips.

Device Description

The FDI Glucose Controls consist of a viscosityadjusted, aqueous liquid control solutions containing known quantities 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 nonhazardous and contains no human or animal derived materials.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for FDI Glucose Controls. This type of document is for in-vitro diagnostic devices (like control solutions for glucose meters), not for AI/ML-driven medical imaging devices or other software-as-a-medical-device that typically require the detailed performance metrics asked for in the prompt.

Therefore, many of the requested fields are not applicable or cannot be extracted from this specific document, as they pertain to clinical efficacy studies for disease diagnosis/prognosis, which are not relevant for a glucose control solution.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

For a control solution, acceptance criteria are typically related to stability and precision, ensuring the control solution itself provides consistent and accurate results for its intended purpose (checking the performance of glucose meters). The document focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit "acceptance criteria" in the context of diagnostic accuracy for a disease.

Acceptance Criteria Category	Reported Device Performance (from "Performance Studies")
Stability	Verified (Accelerated and Real-time Stability)
Open Vial Stability	Verified (Open Vial)
Precision	Verified (Test precision)
Target Range Equivalence	Demonstrated substantial equivalence to predicate device's target ranges. FDI Glucose Controls Level 1: 81-121 mg/dL; Level 2: 172-257 mg/dL; Level 3: 328-490 mg/dL.

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

Sample Size: Not explicitly stated. The document indicates "Tests were performed to verify specific performance characteristics," but does not detail the number of runs, measurements, or individual control solution samples used for each test.
Data Provenance: Not explicitly stated. Assuming internal laboratory testing by Fujirebio Diagnostics, Inc.

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

N/A. This device is a control solution. Ground truth typically refers to a definitive diagnosis or outcome for a patient, which is not applicable here. The "ground truth" for a control solution would be its known glucose concentration, established through highly accurate analytical methods, not expert clinical interpretation.

4. Adjudication method for the test set:

N/A. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in diagnostic tasks. This is not relevant for a control solution's performance testing.

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:

N/A. This study relates to the performance of a glucose control solution, not a diagnostic AI system with human readers.

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

N/A. This device is a control solution, not an algorithm.

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

For the control solution, the "ground truth" for its performance testing would be the known and analytically determined concentrations of glucose within the control solution. This is established through rigorous laboratory methods, not clinical expert consensus or pathology.

8. The sample size for the training set:

N/A. This device is a control solution. It does not involve a "training set" in the context of machine learning. The stability and precision studies are the "performance studies" for this type of device.

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

N/A. (See point 8).

Summary

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K092645

510(k) Premarket Notification: FDI Glucose Controls Fujirebio Diagnostics, Inc.

510(k) Summary 5

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, Inc. SEP 2 5 2009 940 Crossroads Blvd Seguin, TX 78155 (830) 372-1391 ex. 210 Establishment Registration Number: 1643621

Contact Person:

Device Name: FD! Glucose Controls Levels 1, 2. and 3

John C. Gormley

Common Name: Single Analyte Control Solution, All Types (Assayed and Unassayed)

Classification Name: Quality Control Material (assayed and unassayed).

Class I per 21 CFR 862.1660

Product Code:

Classification:

Panel:

Chemistry

75 JJX

Name:

Predicate Devices:

Manufacturer: 510(k) No.:

TRUEcontrol Glucose Control Levels 0, 1, and 2 Home Diagnostics, Inc. K030703

Device Description:

Intended Use:

The FDI Glucose Controls are intended for in vitro diagnostic use (i.e. for external use only) by

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510(k) Premarket Notification: FDI Glucose Controls Fujirebio Diagnostics, Inc.

healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the TrueTrack®, TrackEASE® and TRUEread™ meters and test strips.

Comparison to Predicate Devices:

Characteristic/Aspect	Predicate Device	New Product
Name	TRUEcontrol Glucose Control	FDI Glucose Controls
510(k), Date	K03070308/11/2003
Number of Levels	3	3
Analyte	Glucose	Glucose
Target Range(mg/dL)	83 - 121(1)	81 - 121(2)
	173 - 256(1)	172 - 257(2)
	341 - 516(1)	328 - 490(2)
Container	Plastic bottle with dropper-tip	Plastic bottle with dropper-tip
Fill Volume	3.0 mL	3.6 mL
Color	Red	Red
Matrix	Water, D-glucose, buffers,viscosity enhancing agents,inorganic salts, amaranth, andpreservatives.	Buffered aqueous solution of D-Glucose, a viscosity modifier,preservatives, and other non-reactive ingredients
Indications for Use	To check the performance theTrueTrack®, TrackEASE® andTRUEreadTM meters and teststrips	To check the performance of theTrueTrack®, TrackEASE® andTRUEreadTM meters and teststrips
Target Population	Professional and home use	Professional and home use

(1) Estimated from the manufacturer's published control ranges.

. .

(2)Based on a +/- 5% glucose concentration variability lot-to-lot and +/- 15% range

Performance Studies:

Tests were performed to verify specific performance characteristics:

1. Accelerated and Real-time 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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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES : USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Fuirebio Diagnostics, Inc. c/o Mr. John C. Gormley Director of Quality & Regulatory Affairs 940 Crossroads Blvd. Seguin, TX 78155

SEP 2 5 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

K092645 Re: Trade Name: FDI Glucose Controls Levels 1, 2 and 3 Regulation Number: 21 CFR §862.1660 Regulation Name: Ouality Control Material (assayed and unassayed). Regulatory Class: Class I, Reserved Product Codes: JJX Dated: August 25, 2009 Received: August 27, 2009

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (QSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney C. Harper, 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 Statement 4 510(k) Number (if known): K092645

Device Name: FDI Glucose Controls

Indications for Use:

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

Over-The-Counter Use . (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)

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

K092645 510(k) -

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.