(17 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 TS Blood Glucose Monitor.
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.
The AbT Glucose Control Solution is a quality control material intended for in vitro diagnostic use to assess the performance of the Contour TS Blood Glucose Monitor. The 510(k) summary provides a comparison to predicate devices and outlines performance studies conducted to support the claim of substantial equivalence.
Here's an analysis of the provided information against your requested criteria:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison to predicate devices and lists "Target Range (mg/dL)" under the "Comparison to Predicate Devices" table, which can be interpreted as an acceptance criterion for the control solution's glucose level. The reported performance is the established target range for the new device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Analyte Target Range (mg/dL) | 100 - 145 (mg/dL) |
Note: The document also mentions "performance characteristics" like "Accelerated Stability," "Open Vial," and "Test precision" were verified, but it does not provide specific numerical acceptance criteria or reported performance values for these studies. It only states that tests were performed to verify these characteristics and that the "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for any of the performance studies (Accelerated Stability, Open Vial, Test Precision).
The document does not provide information on the country of origin or whether the data was retrospective or prospective.
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)
This device is a glucose control solution, not an AI or diagnostic imaging device that requires expert interpretation for ground truth. Therefore, the concept of "experts establishing ground truth" as you've framed it (e.g., radiologists) is not applicable here. The ground truth for the control solution's glucose concentration would be established through laboratory analytical methods, not subjective expert assessment. The document does not provide details on the specific analytical methods or individuals who established the true glucose concentration.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for a glucose control solution. Ground truth for a control solution's glucose concentration is determined by analytical measurements, not expert adjudication.
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
Not applicable. This device is a glucose control solution, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to an algorithm's performance without human interaction. This is not applicable as the device is a control solution, not an algorithm. The control solution itself doesn't have an "algorithm" in the typical sense; its performance is based on its chemical properties and stability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a glucose control solution, the "ground truth" for the glucose concentration would be established through analytical laboratory methods (e.g., reference methods for glucose measurement). The document does not explicitly state the specific methods used to establish the ground truth for the control solution's glucose concentration.
8. The sample size for the training set
Not applicable. This device is a manufacturing product (a control solution), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Kogorsy/
510(k) Premarket Notification: AbT Glucose Control Solution American Biological Technologies, Inc. 。
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APR 1 6 2009
5 510(k) Summary
| Introduction: | According to the requirements of 21 CFR 807.92, thefollowing information provides sufficient detail tounderstand the basis for a determination ofsubstantial equivalence. | |
|---|---|---|
| Submitter: | American Biological Technologies, Inc.940 Crossroads BlvdSeguin, TX 78155(830) 372-1391 ex. 210Establishment Registration Number: 1643621 | |
| Contact Person: | John C. Gormley | |
| Device Name: | AbT 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:Manufacturer:510(k) No.: | Contour TS Control SolutionNormalBayer HealthcareK023657 |
| Name:Manufacturer:510(k) No.: | FDTX Glucose Control SolutionAmerican BiologicalTechnologies, Inc.K081915 | |
| Device Description: | The AbT 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 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 Bayer CONTOUR TS Blood Glucose Monitor.
Comparison to Predicate Devices:
| Characteristic/Aspect | Predicate Device No.1 | Predicate Device No.2 | New Product |
|---|---|---|---|
| Name | Contour TS ControlSolution Normal | FDTX Glucose ControlSolution | AbT Glucose ControlSolution |
| 510(k), Date | K02365705/12/2003 | K08191508/08/2008 | |
| Number ofLevels | 1 | 1 | 1 |
| Analyte | Glucose | Glucose | Glucose |
| Target Range(mg/dL) | 99 - 142(1) | 100 - 145(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 solution whichcontains a measuredamount of glucose. | 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 self testing bypeople with diabetesand by healthcareprofessionals as aquality control check. | To check theperformance of theAscensia ContourBlood Glucose System. | To check the performanceof the Contour TS BloodGlucose 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 TS test strips.
(2) From K081915
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510(k) Premarket Notification: AbT Glucose Control Solution American Biological Technologies, Inc.
,
Performance Studies: characteristics:
Tests were performed to verify specific performance
.
- ് 1. Accelerated Stability
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- Open Vial
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- 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with its wings spread and head turned to the side. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
American Biological Technologies, Inc. c/o Mr. John Gormley, Director of Quality & Regulatory Affairs 940 Crossroads Boulevard Seguin, TX 78155
APR 1 6 2009
K090854 Re:
Trade/Device 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 Code: JJX Dated: March 30, 2009 Received: March 30, 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); and good manufacturing practice requirements as set forth in the quality systems (OS) 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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Corg C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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510(k) Premarket Notification: AbT Glucose Control Solution American Biological Technologies, Inc.
4 Indications for Use Statement
510(k) Number (if known):
Device Name: AbT 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 TS Blood Glucose Monitor.
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)
Lucy Phillips
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090854
§ 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.