(21 days)
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 FreeStyle and FreeStyle Lite Blood Glucose Monitors.
The AbT 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 nonhazardous and contains no human or animal derived materials.
Here's a breakdown of the acceptance criteria and the study information for the KCJ3549 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Predicate Device No. 1 (FreeStyle Control Solution) | Predicate Device No. 2 (Liberty Glucose Control) | New Product (AbT Glucose Control Solution) |
|---|---|---|---|
| Analyte | Glucose | Glucose | Glucose |
| Target (mg/dL) | 88 | 88 | 88 |
| Target Range (mg/dL) | 80 - 130 | 80 - 130 | 80 - 130 |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip |
| Fill Volume | 4.0 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | Red |
| Matrix | Buffered aqueous solution of D-Glucose, viscosity modifier, preservatives, and other non-reactive ingredients | Buffered aqueous solution of D-Glucose, a viscosity modifier, preservatives, and other non-reactive ingredients | Identical to Predicate 2 |
| Indications for Use | For use with the FreeStyle blood glucose monitoring system in order to ensure that the FreeStyle meter and FreeStyle test strips are working properly. | Used to check the performance of FreeStyle Blood Glucose Systems. | Used to check the performance of FreeStyle and FreeStyle Lite Blood Glucose Systems. |
| Target Population | Professional and home use | Professional and home use | Professional and home use |
| Stability | Not explicitly stated in table, but performance was verified for predicate, implying the new product also met stability. | Not explicitly stated in table, but performance was verified for predicate, implying the new product also met stability. | Performance verified (implied to meet similar standards). |
| Open Vial | Not explicitly stated in table, but performance was verified for predicate, implying the new product also met open vial. | Not explicitly stated in table, but performance was verified for predicate, implying the new product also met open vial. | Performance verified (implied to meet similar standards). |
| Mean and Variance Comparison | Not explicitly stated in table, but performance was verified for predicate, implying the new product also met mean/variance comparison. | Not explicitly stated in table, but performance was verified for predicate, implying the new product also met mean/variance comparison. | Performance verified (implied to meet similar standards). |
Study that Proves the Device Meets Acceptance Criteria:
The document states: "Performance Studies: Tests were performed to verify specific performance characteristics: 1. Stability 2. Open Vial 3. Mean and Variance Comparison."
The conclusion is: "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence."
This indicates that the AbT Glucose Control Solution was subjected to these performance studies, and the results demonstrated that it met the necessary criteria, leading to the determination of substantial equivalence to the predicate devices. The acceptance criteria themselves are primarily defined by the characteristics of the predicate devices (e.g., target range, fill volume, matrix, intended use) to which the new device is compared. The specific acceptance thresholds for "Stability," "Open Vial," and "Mean and Variance Comparison" are not detailed in this summary but are implicit in the performance verification.
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not specify the sample size used for the test set in the performance studies (Stability, Open Vial, Mean and Variance Comparison).
The document does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The device is a "Quality Control Material," and its "ground truth" would typically refer to the measured glucose concentration within the control solution itself, established through analytical methods rather than expert consensus on diagnostic images or patient data.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessments, such as evaluating medical images. For a glucose control solution, the performance is assessed through quantitative measurements against established standards.
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
There was no MRMC comparative effectiveness study done. This type of study involves human readers interpreting cases, often with and without AI assistance, to assess the impact of AI on human performance. The device in question, an AbT Glucose Control Solution, is a quality control material and not an AI-powered diagnostic device that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a chemical control solution, not an algorithm or AI system.
7. The Type of Ground Truth Used
For a glucose control solution, the "ground truth" is the known, assayed concentration of glucose within the solution itself. This would be established through laboratory analytical methods (e.g., reference methods for glucose measurement). The document implicitly refers to this "target" glucose level (88 mg/dL) and "target range" (80-130 mg/dL).
8. The Sample Size for the Training Set
This information is not applicable/provided. The device is a manufacturing product (a glucose control solution), not an AI algorithm that requires a training set. The "formulation" is the key aspect, not a statistical training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated in point 8.
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KCJ3549
510(k) Summary 5.
DEC 2 2 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: American Biological Technologies, Inc. (AbT) 940 Crossroads Blvd Seguin, TX 78155 (830) 372-1391 ex. 210 Establishment Registration Number: 1643621 Contact Person: John C. Gormley Device Name: AbT 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: Freestyle Control Solution Manufacturer: Abbott Diabetes Care, Inc. 510(k) No.: K031260 Name: Liberty Glucose Control Manufacturer: Liberty Healthcare Group K060481 510(k) No.: Device Description: The AbT 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 nonhazardous and contains no human or animal derived materials.
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Intended Use: The AbT Glucose Control Solution is intended 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 FreeStyle and FreeStyle Lite Blood Glucose Monitor.
Comparison to Predicate Device:
| Characteristic/Aspect | Predicate Device No. 1 | Predicate Device No. 2 | New Product |
|---|---|---|---|
| Name | FreeStyle Control Solution | Liberty Glucose Control | AbT Glucose ControlSolution |
| 510(k), Date | K031260, 12/19/2003 | K060481, 3/09/2006 | |
| Number ofLevels | 1 | 1 | 1 |
| Analyte | Glucose | Glucose | Glucose |
| Target (mg/dL) | 88 | 88 | 88 |
| Target Range(mg/dL) | 80 - 130(1) | 80 - 130(2) | 80 - 130 |
| Container | Plastic bottle with dropper-tip | Plastic bottle withdropper-tip | Plastic bottle withdropper-tip |
| Fill Volume | 4.0 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | Red |
| Matrix | Buffered aqueous solutionof D-Glucose, viscositymodifier, preservatives, andother non-reactiveingredients | Buffered aqueoussolution of D-Glucose, aviscosity modifier,preservatives, and othernon-reactive ingredients | Identical to Predicate2 which ismanufactured byAbT. |
| Indications forUse | For use with the FreeStyleblood glucose monitoringsystem in order to ensurethat the FreeStyle meter andFreeStyle test strips areworking properly. | Used to check theperformance ofFreeStyle BloodGlucose Systems. | Used to check theperformance ofFreeStyle andFreeStyle Lite BloodGlucose Systems. |
| TargetPopulation | Professional and home use | Professional and homeuse | Professional andhome use |
(1) Estimated using published control ranges assigned by the manufacturer for several lots of FreeStyle Lite test strips.
(2)AbT's target range for the Liberty Glucose Control.
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Performance Studies: Tests were performed to verify specific performance characteristics:
-
- Stability -
-
- Open Vial
-
- Mean and Variance Comparison
Conclusion: Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Re:
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
American Biological Technologies, Inc. c/o John Gormley Director of Quality and Regulatory Affairs 940 Crossroads Blvd. Seguin, TX 78155
DEC 2 2 2008
K083549 Trade Name: AbT Glucose Control Solution Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJX Dated: December 1, 2008 Received: December 1, 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, Or vo 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 tollogy and (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
510(k) Number (if known): K083549
AbT 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 FreeStyle and FreeStyle Lite Blood Glucose Monitors.
Prescription Use (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)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083549
§ 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.