(45 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 FreeStyle Lite Blood Glucose Monitor.
The FDI 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) premarket notification for the FDI Glucose Control Solution, a quality control material used with the FreeStyle Lite Blood Glucose Monitor. It does not describe a medical device that uses AI or performs any diagnostic function independently.
Therefore, many of the requested sections are not applicable to this document as they pertain to studies for diagnostic devices, particularly those involving AI or human interpretation.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical diagnostic study with sensitivity, specificity, etc. Instead, it aims to demonstrate substantial equivalence to a predicate device. The performance characteristics compared are:
| Characteristic/Aspect | Predicate Device No. 1 (AbT Glucose Control Solution) | New Product (FDI Glucose Control Solution) | Acceptance and Performance |
|---|---|---|---|
| Target (mg/dL) | 88 | 88 | Met: Identical target |
| Target Range (mg/dL) | 80 – 130 | 75 - 125 | Met: A specific range is defined for both, although the new product has a slightly narrower range, it's within expected control variations. The document notes the predicate's range was for "Liberty Glucose Control" (possibly an earlier version or related product). |
| Formulation (Matrix) | Buffered aqueous solution of D-Glucose, a viscosity modifier, preservatives, and other non-reactive ingredients | Identical to Predicate 1 | Met: Stated as identical. |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip | Met: Identical container. |
| Fill Volume | 3.6 mL | 3.6 mL | Met: Identical fill volume. |
| Color | Red | Red | Met: Identical color. |
| Intended Use | Used to check the performance of FreeStyle and FreeStyle Lite Blood Glucose Systems. | Used to check the performance of FreeStyle Lite Blood Glucose Systems. | Met: Similar intended use, specifically refined to FreeStyle Lite. |
Study that Proves Device Meets Acceptance Criteria:
The "Performance Studies" section (Section 2) mentions:
- Stability
- Open Vial
- Mean and Variance Comparison
The conclusion states: "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence." This implies that these studies demonstrated that the FDI Glucose Control Solution performed comparably to its predicate device across these aspects. However, specific numerical results or detailed methodology for these studies are not provided in the extracted text.
The following points are not applicable to this document as it describes a simple control solution, not a diagnostic device involving AI, human interpretation, or complex clinical outcome studies.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This is a control solution, and the "performance studies" are likely laboratory-based characterization, not a clinical trial with patient data or test sets in the typical sense.
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)
- Not applicable. Ground truth for a glucose control solution is established by its chemical composition and manufacturing specifications, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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 does not involve human readers, AI assistance, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For a control solution, the "ground truth" for its characteristics (e.g., glucose concentration, pH, stability) is established by analytical chemistry and manufacturing standards and specifications.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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102260 EP 2 4 2010
5. 510(k) Summary
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, Inc. (FDI) 940 Crossroads Blvd Seguin, TX 78155 (830) 372-1391 ex. 213 Establishment Registration Number: 1643621 Contact Person: Kent Pruett Device Name: FDI 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: AbT Glucose Control Solution Manufacturer: Fujirebio Diagnostics, Inc. 510(k) No.: : K083549 Device Description: The FDI 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.
Page 13 of 37
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Intended Use:
- The FDI 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 FreeStyle Lite Blood Glucose Monitor
| Characteristic/Aspect | Predicate Device No. 1 | New Product |
|---|---|---|
| Name | AbT Glucose Control Solution | FDI Glucose Control Solution |
| 510(k), Date | K083549, 12/22/2008 | |
| Number ofLevels | 1 | 1 |
| Analyte | Glucose | Glucose |
| Target (mg/dL) | 88 | 88 |
| Target Range(mg/dL) | 80 – 130(1) | 75 - 125 |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip |
| Fill Volume | 3.6 mL | 3.6 mL |
| Color | Red | Red |
| Matrix | Buffered aqueous solution of D-Glucose, aviscosity modifier, preservatives, and othernon-reactive ingredients | Identical to Predicate 1 which ismanufactured by FDI. |
| Indications forUse | Used to check the performance ofFreeStyle and FreeStyle Lite BloodGlucose Systems. | Used to check the performanceof FreeStyle Lite Blood GlucoseSystems. |
| TargetPopulation | Professional and home use | Professional and home use |
Comparison to Predicate Device:
(1) FDI's target range for the Liberty Glucose Control.
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Performance Studies:
Tests were performed to verify specific performance . characteristics:
-
- Stability
-
- Open Vial
-
- Mean and Variance Comparison
Conclusion:
Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with three swooping lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Fujirebio Diagnostics, Inc. c/o Mr. Kent Pruett Director Quality Assurance & Regulatory Affairs 940 Crossroads Blvd. Seguin, TX 78155
SEP 2 4 2010
K102260 Re:
Trade Name: FDI Glucose Control Solution Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJX Dated: August 10, 2010 Received: August 10, 2010
Dear Mr. Pruett:
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 (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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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courtney Harper, Ph.D. 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): ____________________________________________________________________________________________________________________________________________________
FDI Glucose Control Solution Device Name:
SEP 2 4 2010
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 FreeStyle Lite Blood Glucose Monitor.
Prescription Use X (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)
Dia
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K10 22-60
§ 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.