(54 days)
Not Found
No
The device description and intended use clearly define a glucose control solution, which is a chemical reagent used to verify the accuracy of a blood glucose monitor. There is no mention of any computational or algorithmic processing, let alone AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The document describes a control solution for testing a blood glucose monitor, which is an in vitro diagnostic device used to check the accuracy of the monitor, not to treat a medical condition.
Yes
This device is for "in vitro diagnostic use" to assess the performance of a blood glucose monitor, which is itself a diagnostic device. The control solution helps verify the accuracy of the diagnostic measurements.
No
The device description explicitly states it is an "aqueous liquid control solution" packaged in a "plastic dropper tipped bottle," indicating it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the Intended Use: The very first line of the "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use".
- Purpose of the device: The device is a "Glucose Control Solution" used to "assess the performance of the Agamatrix WaveSense Presto Blood Glucose Monitor". This means it's used in vitro (outside the body) to check the accuracy and functionality of another diagnostic device (the blood glucose monitor).
- Nature of the device: It's a liquid control solution containing a known quantity of glucose, designed to be applied to test strips. This is a typical characteristic of a control material used in in vitro diagnostic testing.
Therefore, based on the provided information, this device fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AbT Glucose Control Solution is intended for in 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.
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.
Product codes
75 JJX, JJX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals and in the home by people with diabetes mellitus
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Study type: Stability, Open Vial Stability, Test Precision
Sample size: Not Found
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results: Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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| 5
| 510(k) Summary | MAY 27 2009 | ||
|---|---|---|---|
| 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. | ||
| 940 Crossroads Blvd | |||
| Seguin, TX 78155 | |||
| (830) 372-1391 ex. 210 | |||
| Establishment Registration Number: 1643621 | |||
| Contact Person: | John C. Gormley | ||
| American Biological Technologies, Inc. | |||
| 940 Crossroads Blvd | |||
| Seguin, TX 78155 | |||
| (830) 372-1391 ex. 210 | |||
| 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: | WaveSense Normal Control | |
| Solution | |||
| Manufacturer: | |||
| 510(k) No.: | AgaMatrix, Inc. | ||
| K052762 | |||
| Name: | |||
| Manufacturer: | |||
| 510(k) No.: | Liberty Normal Control Solution | ||
| Liberty Healthcare Group, Inc. | |||
| K063855 | |||
| Device Description: | The AbT Glucose Control Solution consists of a | ||
| viscosity-adjusted, aqueous liquid control solution | |||
| containing a known quantity of glucose. It is | |||
| Characteristic/ | |||
| Aspect | Predicate Device No. | ||
| 1 | Predicate Device | ||
| No. 2 | New Product | ||
| Name | WaveSense Normal | ||
| Control Solution | Liberty Normal | ||
| Control Solution | AbT Glucose | ||
| Control 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-tip | ||
| 6 mL | dropper tip | ||
| 3.6 mL | dropper tip | ||
| 3.6 mL | |||
| Color | Blue | Red | Red |
| Target | 108 - 159(1) | 94 - 147(2) | 95 - 145 |
| Matrix | Buffered aqueous | ||
| solution of D-Glucose, | |||
| viscosity modifier, | |||
| preservatives, and | |||
| other non-reactive | |||
| ingredients | Buffered aqueous | ||
| solutions of D- | |||
| Glucose, viscosity | |||
| modifiers, | |||
| preservatives, and | |||
| other non-reactive | |||
| ingredients | Buffered aqueous | ||
| solutions of D- | |||
| Glucose, viscosity | |||
| modifiers, | |||
| preservatives, and | |||
| other non-reactive | |||
| ingredients | |||
| Indications for Use | Used with the | ||
| WaveSense-enabled | |||
| Blood Glucose Meter | |||
| and WaveSense Test | |||
| Strips to ensure that | |||
| the meter and test | |||
| strips are working | |||
| together properly. | Used to check the | ||
| performance of | |||
| Liberty Blood | |||
| Glucose Monitoring | |||
| System. | Used to check the | ||
| performance of | |||
| AgaMatrix | |||
| WaveSense Presto | |||
| Glucose Monitoring | |||
| System. | |||
| Target Population | Professional and | ||
| home use | Professional and | ||
| home use | Professional and | ||
| home use |
1
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.
2
| 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.
3
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).
4
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
5
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