(62 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 Blood Glucose Monitor
The FDI Glucose Control Solution for FreeStyle 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 non-hazardous and contains no human or animal derived materials.
The provided document is a 510(k) Premarket Notification for the "FDI Glucose Control Solution For FreeStyle," a quality control material, rather than a device that employs AI or requires extensive clinical studies with human readers. Therefore, several of the requested sections (e.g., MRMC studies, training set details, expert ground truth adjudication) are not applicable to this type of submission.
However, I can extract the relevant information regarding acceptance criteria and performance studies for this specific product.
1. Table of Acceptance Criteria and the Reported Device Performance
| Characteristic/Aspect | Acceptance Criteria (Predicate Device K102260) | Reported Device Performance (New Product) |
|---|---|---|
| Number of Levels | 1 | 1 |
| Analyte | Glucose | Glucose |
| Target (mg/dL) | 88 | 88 |
| Target Range (mg/dL) | 75 – 125 | 70-120 |
| 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, a viscosity modifier, preservatives, and other non-reactive ingredients | Identical to Predicate 1, manufactured by FDI |
| Indications for Use | Used to check the performance of FreeStyle Lite Blood Glucose Systems. | Used to check the performance of FreeStyle Blood Glucose Systems. (Note: The new device is for "FreeStyle" monitors, while the predicate was for "FreeStyle Lite." This is a change in the specific system it's intended to check, but otherwise the type of use is the same). |
| Target Population | Professional and home use | Professional and home use |
Note: The acceptance criteria for the new device are primarily demonstrated by its similarity and equivalence to a previously cleared predicate device (K102260). The "Target Range" shows a slight adjustment (75-125 mg/dL to 70-120 mg/dL), which is likely a refined specification based on the FreeStyle system it's calibrated for. The performance studies mentioned below confirm that the new device meets its own specifications and is substantially equivalent.
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of clinical trials with patient data, as this is a quality control solution. The performance was evaluated through:
- Stability studies: These typically involve testing the product over time under various conditions. The sample size would refer to the number of vials tested at different time points, but specific numbers are not detailed.
- Open Vial studies: Similar to stability, but specifically once the vial has been opened and exposed to air.
- Mean and Variance Comparison: This involves measuring the glucose concentration of the control solution repeatedly using the FreeStyle Blood Glucose Monitor and comparing the results to the established target and range. The number of replicates or individual tests performed is not explicitly stated.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory data generated by Fujirebio Diagnostics, Inc. (FDI) in the United States, given their address.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a quality control solution with a known chemical composition and target glucose concentration. Its "ground truth" is established by its formulation and analytical chemistry, not by expert interpretation of patient data.
4. Adjudication method for the test set
Not applicable. Ground truth for a quality control solution is based on its manufacturing specifications and analytical measurements, not a consensus of experts.
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 is a quality control solution, not an AI-powered diagnostic device, and does not involve human readers interpreting images or data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This product is a chemical solution, not an algorithm or software. Its performance is measured directly by how accurately it registers on the FreeStyle Blood Glucose Monitor when used by a human.
7. The type of ground truth used
The ground truth for the FDI Glucose Control Solution for FreeStyle is its known chemical concentration of glucose and its intended target range (70-120 mg/dL). This is established through its manufacturing process and analytical validation.
8. The sample size for the training set
Not applicable. As a chemical control solution, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. There is no concept of a "training set" for this device.
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510(k) Premarket Notification: FDI Glucose Control Solution For FreeStyle
Fujirebio Diagnostics, Inc.
JAN 2 5 2011
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: | Fujirebio Diagnostics, Inc. (FDI)940 Crossroads BlvdSeguin, TX 78155(830) 372-1391 ex. 213Establishment Registration Number: 1643621 | |
| Contact Person: | Kent Pruett | |
| Device Name: | FDI Glucose Control Solution for FreeStyle | |
| 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.: | FDI Glucose Control SolutionFujirebio Diagnostics, Inc.K102260 |
| Device Description: | The FDI Glucose Control Solution for FreeStyleconsists of a viscosity-adjusted, aqueous liquidcontrol solution containing a known quantity ofglucose. The product is packaged in plastic droppertipped bottles for easy application of the controlsolutions to the test strips and a red coloration to aidthe user to visually confirm application of the control.The product is non-hazardous and contains no humanor animal derived materials. |
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510(k) Premarket Notification: FDI Glucose Control Solution For FreeStyle Fujirebio Diagnostics, Inc.
The FDI Glucose Control Solution for FreeStyle Intended Use: 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 Blood Glucose Monitor
| Characteristic/Aspect | Predicate Device No. 1 | New Product |
|---|---|---|
| Name | FDI Glucose Control Solution | FDI Glucose Control Solutionfor FreeStyle |
| 510(k), Date | K102260, 09/24/2010 | |
| Number ofLevels | 1 | 1 |
| Analyte | Glucose | Glucose |
| Target (mg/dL) | 88 | 88 |
| Target Range(mg/dL) | 75 – 125(1) | 70-120 |
| 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 whichis manufactured by FDI. |
| Indications forUse | Used to check the performance of FreeStyleLite Blood Glucose Systems. | Used to check theperformance of FreeStyleBlood Glucose Systems. |
| TargetPopulation | Professional and home use | Professional and home use |
Comparison to Predicate Device:
TFFDI's target range for the Freestyle Glucose Control.
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510(k) Premarket Notification: FDI Glucose Control Solution For FreeStyle Fujirebio Diagnostics, Inc.
.
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/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Fujirebio Diagnostics, Inc. c/o Mr. Kent Pruett Director Quality Assurance and Regulatory Affairs 940 Crossroads Blvd. Seguin. Texas 78155
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
· JAN 2 5 201
K103450 Trade Name: FDI Glucose Control Solution for FreeStyle Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: November 1, 2010 Received: November 24, 2010
Dear Mr. Pruett:
Re:
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).
LANY
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 80) 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 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,
CJC.
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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510(k) Premarket Notification: FDI Glucose Control Solution Fujirebio Diagnostics, Inc.
4. Indications for Use Statement
510(k) Number (if known): K103450
FDI Glucose Control Solution for FreeStyle Device Name:
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 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 of Owner or Officer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 1/103452
§ 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.