(54 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 Agamatrix WaveSense Presto Blood Glucose Monitor.
The AbT Glucose Control Solution consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. It is packaged in a plastic dropper tipped bottle for easy application of the control solution 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 control material for blood glucose monitoring systems. The provided documentation does not detail a study involving human readers or comparative effectiveness for diagnostic image analysis. Instead, it describes a device for quality control in glucose measurement. The performance studies focused on the stability and precision of the control solution itself, not on diagnostic accuracy in the way an AI-powered image analysis tool would be evaluated.
Here's an analysis based on the provided text, reformatted to address your specific questions about acceptance criteria and study details, albeit adapted for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
For the AbT Glucose Control Solution, the "acceptance criteria" are defined by its target glucose range and its ability to maintain stability and precision within that range. The "reported device performance" reflects how these characteristics compare to predicate devices.
| Characteristic | Acceptance Criteria (Predicate Devices - Target Ranges) | Reported Device Performance (New Product - Target Range) |
|---|---|---|
| Glucose Target Range | WaveSense Normal Control Solution: 108 - 159 | AbT Glucose Control Solution: 95 - 145 |
| Liberty Normal Control Solution: 94 - 147 | ||
| Stability | Implied comparable stability to predicate devices | Found to be acceptable (see "Performance Studies") |
| Open Vial Stability | Implied comparable open vial stability | Found to be acceptable (see "Performance Studies") |
| Test Precision | Implied comparable precision to predicate devices | Found to be acceptable (see "Performance Studies") |
Note: The specific quantitative results for stability and precision are not provided in this summary but are indicated as having been performed and concluded to be satisfactory.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of diagnostic performance on patient data since this device is a quality control solution.
- Sample Size: Not applicable in the traditional sense of patient data. The "samples" would be aliquots of the control solution itself. The document does not provide the number of replicates or batches tested for stability and precision studies.
- Data Provenance: Not applicable in the context of patient data. The studies would have been conducted internally by American Biological Technologies, Inc. No country of origin for patient data is relevant here. The studies are prospective in nature, testing the manufactured control solution.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. "Ground truth" for a control solution relates to its manufactured glucose concentration and its stability and precision characteristics, not diagnostic interpretations by experts. The "ground truth" would be established through analytical chemistry methods during production and quality control testing.
4. Adjudication Method
Not applicable. Adjudication methods are relevant for expert review of diagnostic cases, which is not the purpose of this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a quality control solution, not a diagnostic tool intended for interpretation by human readers. Therefore, an MRMC study is not relevant.
6. Standalone Performance
Yes, in a sense. The "performance studies" (stability, open vial stability, test precision) are evaluations of the AbT Glucose Control Solution itself and its inherent characteristics. This is a form of standalone performance assessment, focusing on the quality and reliability of the control solution as a product. The results of these studies informed the claim of substantial equivalence to predicate devices.
7. Type of Ground Truth Used
The "ground truth" for the AbT Glucose Control Solution is based on analytical manufacturing specifications and laboratory testing.
- Glucose Concentration: The target range (95 - 145) is a defined analytical specification for the product.
- Stability: This is determined by monitoring the glucose concentration over time under various storage conditions.
- Precision: This is determined by repeatedly measuring the glucose concentration and analyzing the variability.
8. Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a "training set" of data. Its "performance" is based on its physical and chemical properties as a control solution.
9. How Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth to establish in this context.
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| 5510(k) Summary | MAY 27 2009 | ||
|---|---|---|---|
| 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. GormleyAmerican Biological Technologies, Inc.940 Crossroads BlvdSeguin, TX 78155(830) 372-1391 ex. 210 | ||
| 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: | WaveSense Normal ControlSolution | |
| Manufacturer:510(k) No.: | AgaMatrix, Inc.K052762 | ||
| Name:Manufacturer:510(k) No.: | Liberty Normal Control SolutionLiberty Healthcare Group, Inc.K063855 | ||
| Device Description: | The AbT Glucose Control Solution consists of aviscosity-adjusted, aqueous liquid control solutioncontaining a known quantity of glucose. It is | ||
| Characteristic/Aspect | Predicate Device No.1 | Predicate DeviceNo. 2 | New Product |
| Name | WaveSense NormalControl Solution | Liberty NormalControl Solution | AbT GlucoseControl Solution |
| 510(k), Date | K052762, 01/23/2006 | K063855, 02/01/2007 | |
| Number of Levels | 1 | 1 | 1 |
| Analytes | Glucose | Glucose | Glucose |
| Container | Plastic bottle with | Plastic bottle with | Plastic bottle with |
| Fill Volume | dropper-tip6 mL | dropper tip3.6 mL | dropper tip3.6 mL |
| Color | Blue | Red | Red |
| Target | 108 - 159(1) | 94 - 147(2) | 95 - 145 |
| Matrix | Buffered aqueoussolution of D-Glucose,viscosity modifier,preservatives, andother non-reactiveingredients | Buffered aqueoussolutions of D-Glucose, viscositymodifiers,preservatives, andother non-reactiveingredients | Buffered aqueoussolutions of D-Glucose, viscositymodifiers,preservatives, andother non-reactiveingredients |
| Indications for Use | Used with theWaveSense-enabledBlood Glucose Meterand WaveSense TestStrips to ensure thatthe meter and teststrips are workingtogether properly. | Used to check theperformance ofLiberty BloodGlucose MonitoringSystem. | Used to check theperformance ofAgaMatrixWaveSense PrestoGlucose MonitoringSystem. |
| Target Population | Professional andhome use | Professional andhome use | Professional andhome use |
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packaged in a plastic dropper tipped bottle for easy application of the control solution 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 intended for in Intended Use: vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the WaveSense Presto Blood Glucose Monitoring System.
Comparison to Predicate Device:
(1)Estimated from WaveSense Presto test strip lots published ranges.
(2)Estimated from Liberty Normal Control Solution published control ranges.
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| Performance Studies: | Tests were performed to verify specific performance characteristics: |
|---|---|
| ---------------------- | ---------------------------------------------------------------------- |
-
- Stability
- . 2. Open Vial Stability
- 3. 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 and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 27 2009
American Biological Technologies, Inc. c/o Mr. John Gormley Director of Quality and Regulatory Affairs 940 Crossroads Blvd. Seguin, TX 78155
Re: K090943
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: May 5, 2009 Received: May 11, 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 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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Paqe - 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 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 (240) 276-0450. 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 (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.H.
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
Enclosure
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Indications for Use Statement 4
510(k) Number (if known): K
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 Agamatrix WaveSense Presto Blood Glucose Monitor.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 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
510(k) K090943
Office of In Vitro Diagnostic Device Evaluation and Safety
§ 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.