(36 days)
Not Found
No
The device description and performance studies focus on the chemical properties and stability of a glucose control solution, with no mention of AI/ML algorithms or data processing.
No
This device is a control solution used to assess the performance of a blood glucose monitor, not to treat a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use". This phrase indicates that the device is used for diagnostic purposes outside of the body.
No
The device description clearly states it is a liquid control solution packaged in bottles, indicating it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first line explicitly states "For in vitro diagnostic use".
- Device Description: It describes a "control solution" used to "assess the performance of the Contour Blood Glucose Monitor." Control solutions for blood glucose monitors are a classic example of IVD devices. They are used to verify that the test system (the monitor and test strips) is working correctly.
The other sections, while providing useful information about the device, don't contradict its classification as an IVD. The fact that it's used by healthcare professionals and in the home, and that it has predicate devices that are also control solutions, further supports its IVD nature.
N/A
Intended Use / Indications for 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.
Product codes
75 JJX, JJX
Device Description
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.
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
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.
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
AUG - 8 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: | Fujirebio Diagnostics Texas, Inc.
940 Crossroads Blvd
Seguin, TX 78155
(830) 372-1391 ex. 210
Establishment Registration Number: 1643621 |
| Contact Person: | John C. Gormley |
| Device Name: | FDTX 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: Ascensia Microfill Control
Solution
Manufacturer: Bayer Healthcare
510(k) No.: K023657 |
| | Name: Liberty Normal Glucose Control
Solution
Manufacturer: Liberty Healthcare Group
510(k) No.: K060706 |
| Device Description: | 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 |
1
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 | Ascensia
Contour/Microfill
Control Solution | Liberty Normal Glucose
Control | FDTX Glucose Control
Solution |
| 510(k), Date | K023657
05/12/2003 | K060706, 04/28/2006 | |
| Number of
Levels | 1 | 1 | 1 |
| Analyte | Glucose | Glucose | Glucose |
| Target Range
(mg/dL) | $100 - 143^{(1)}$ | $90 - 130^{(2)}$ | 100 - 145 |
| Container | Plastic bottle with
dropper-tip | Plastic bottle with
dropper-tip | Plastic bottle with
dropper-tip |
| Fill Volume | 2.5 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | Red |
| Matrix | Aqueous Glucose
solution. | Buffered aqueous
solution of D-Glucose,
a viscosity modifier,
preservatives, and
other non-reactive
ingredients | Buffered aqueous solution
of D-Glucose, a viscosity
modifier, preservatives,
and other non-reactive
ingredients |
| Indications for
Use | For use with the
Ascensia Contour
Blood Glucose Meter
and the Ascensia
MICROFILL Test Strips
as a quality control
check. | To check the
performance of
OneTouch Ultra,
OneTouch FastTake,
Accu-Chek Active, and
Ascensia Contour
Blood Glucose
Systems. | To check the performance
of the Ascensia Contour
Blood Glucose System. |
| Target
Population | Professional and home
use | Professional and home
use | Professional and home
use |
(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.
2
- 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.
3
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
5
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