(36 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 Contour Blood Glucose Monitor.
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 nonhazardous and contains no human or animal derived materials.
The provided text describes a 510(k) submission for the FDTX Glucose Control Solution. While it outlines the device's purpose and general performance studies, it does not contain the detailed acceptance criteria or the specific results of those studies that would precisely demonstrate the device meets those criteria.
However, based on the information provided, we can infer some aspects and construct a table of claimed performance, acknowledging that specific numerical acceptance criteria are missing. The study is a comparison to predicate devices and performance studies were conducted to show substantial equivalence.
Here's an attempt to answer your request based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred/General) | Reported Device Performance (Claimed/Implied) |
|---|---|
| Intended Use: For in vitro diagnostic use by healthcare professionals and people with diabetes mellitus to assess the performance of the Bayer Ascensia Contour Blood Glucose Monitor. | Matches Intended Use of Predicate: "To check the performance of the Ascensia Contour Blood Glucose System." (Directly comparable to predicate devices' intended use) |
| Analyte: Contains glucose. | Contains Glucose: "viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose." |
| Number of Levels: Comparable to predicate devices (1 level). | 1 Level: Matches predicate devices. |
| Target Range (mg/dL): Within a clinically acceptable range for glucose control solutions, comparable to predicate devices. | 100 - 145 mg/dL: Comparable to predicate devices (100-143 mg/dL and 90-130 mg/dL). |
| Physical Characteristics (Container, Volume, Color): Similar to predicate devices for user familiarity and compatibility. | Plastic bottle with dropper-tip, 3.6 mL, Red: Matches predicate device characteristics. |
| Matrix: Aqueous solution with specific components (viscosity modifier, preservatives, non-reactive ingredients) | Buffered aqueous solution of D-Glucose, a viscosity modifier, preservatives, and other non-reactive ingredients: Matches predicate device 2's matrix. |
| Safety: Non-hazardous, no human/animal derived materials. | Non-hazardous and contains no human or animal derived materials. |
| Stability (Accelerated): Maintains specified performance over time under accelerated conditions. | "Tests were performed to verify specific performance characteristics: 1. Accelerated Stability" (Implies successful verification, but no data provided) |
| Open Vial Stability: Maintains specified performance after the vial is opened for a defined period. | "Tests were performed to verify specific performance characteristics: 2. Open Vial" (Implies successful verification, but no data provided) |
| Precision: Demonstrates acceptable level of consistency in results. | "Tests were performed to verify specific performance characteristics: 3. Test precision" (Implies successful verification, but no data provided) |
| Substantial Equivalence: Demonstrated to be as safe and effective as a legally marketed predicate device. | "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence." (Conclusion of the submission) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The text only mentions "Tests were performed to verify specific performance characteristics." This implies specific samples (e.g., lots of control solution, measurements taken) were used but their size is not disclosed.
- Data Provenance: Not explicitly stated. Given it's a 510(k) submission to the FDA, it would be laboratory data generated by the manufacturer (Fujirebio Diagnostics Texas, Inc.). It's likely prospective testing conducted in a controlled lab environment. No information on country of origin for the data is provided beyond the company's location in Texas, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is a control solution, not a diagnostic AI or imaging device that requires expert interpretation for ground truth. The "ground truth" for a control solution is typically the assigned value of the analyte (glucose) within the control solution, determined by a reference method or validated analytical process.
- Therefore, the concept of "experts establishing ground truth" in the way it applies to diagnostic interpretation (e.g., radiologists) is not applicable here. The ground truth for the glucose concentration would be established through chemical analysis methods rather than expert consensus on images or pathological findings.
4. Adjudication method for the test set
- Not applicable as the and evaluation of performance characteristics for a control solution does not involve "adjudication" in the sense of reconciling differing expert opinions on a diagnostic case. The performance is assessed against established analytical methods and statistical criteria.
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 relevant for diagnostic devices (especially imaging AI) where human interpretation is involved. The FDTX Glucose Control Solution is a quality control material for a blood glucose monitor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable to the FDTX Glucose Control Solution. It is a physical control solution, not an algorithm or AI device. Its performance is evaluated through its chemical stability, accuracy, and precision when used with a blood glucose monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the FDTX Glucose Control Solution is the assigned glucose concentration within the solution, determined by a validated analytical method and internal quality control processes. This is an objective chemical measurement, not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Not applicable. This device is a control solution, a physical product, not an AI/ML algorithm that requires a "training set." The product's characteristics are developed through chemical formulation and analytical testing, not machine learning.
9. How the ground truth for the training set was established
- Not applicable. As there is no "training set" for this device, the concept of establishing ground truth for it is irrelevant.
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5 510(k) Summary
AUG - 8 2008
| Introduction: | According to the requirements of 21 CFR 807.92, thefollowing information provides sufficient detail tounderstand the basis for a determination ofsubstantial 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 (Assayedand 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: Ascensia Microfill ControlSolutionManufacturer: Bayer Healthcare510(k) No.: K023657 |
| Name: Liberty Normal Glucose ControlSolutionManufacturer: Liberty Healthcare Group510(k) No.: K060706 | |
| Device Description: | The FDTX Glucose Control Solution consists of aviscosity-adjusted, aqueous liquid control solutioncontaining a known quantity of glucose. The productis packaged in plastic dropper tipped bottles for easyapplication of the control solutions to the test stripsand a red coloration to aid the user to visually confirm |
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application of the control. The product is nonhazardous and contains no human or animal derived materials.
Intended Use: The FDTX 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 Bayer Ascensia Contour Blood Glucose Monitor.
Comparison to Predicate Devices:
| Characteristic/Aspect | Predicate Device No.1 | Predicate Device No.2 | New Product |
|---|---|---|---|
| Name | AscensiaContour/MicrofillControl Solution | Liberty Normal GlucoseControl | FDTX Glucose ControlSolution |
| 510(k), Date | K02365705/12/2003 | K060706, 04/28/2006 | |
| Number ofLevels | 1 | 1 | 1 |
| Analyte | Glucose | Glucose | Glucose |
| Target Range(mg/dL) | $100 - 143^{(1)}$ | $90 - 130^{(2)}$ | 100 - 145 |
| 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 | Red | Red | Red |
| Matrix | Aqueous Glucosesolution. | Buffered aqueoussolution of D-Glucose,a viscosity modifier,preservatives, andother non-reactiveingredients | Buffered aqueous solutionof D-Glucose, a viscositymodifier, preservatives,and other non-reactiveingredients |
| Indications forUse | For use with theAscensia ContourBlood Glucose Meterand the AscensiaMICROFILL Test Stripsas a quality controlcheck. | To check theperformance ofOneTouch Ultra,OneTouch FastTake,Accu-Chek Active, andAscensia ContourBlood GlucoseSystems. | To check the performanceof the Ascensia ContourBlood Glucose System. |
| TargetPopulation | Professional and homeuse | Professional and homeuse | Professional and homeuse |
(1) Estimated from published control ranges assigned by the manufacturer for several lots of Contour test strips.
(2)Estimated from published control ranges assigned by the manufacturer for several lots of Liberty Normal Glucose Control.
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- Performance Studies: Tests were performed to verify specific performance characteristics:
-
- Accelerated Stability
-
- Open Vial
-
- Test precision
-
- Conclusion: Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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: K081915 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 27, 2008 Received: July 3, 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.
Yean 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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4 Indications for Use Statement
510(k) Number (if known): 081915
Device Name: FDTX Glucose Control Solution
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 Contour 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)
Signature
Div sign /Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081915
§ 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.