(55 days)
The FDI Glucose Control Solution is intended for use with Aviva Plus test strip when used on the Accu-Chek® Aviva blood glucose meter. The control solution is used with the Aviva Plus test strips to check that the meter and test strips are working together properly.
The FDI Glucose Control Solution for Aviva 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the FDI Glucose Control Solution for Accu-Chek Aviva:
Acceptance Criteria and Device Performance Study for FDI Glucose Control Solution for Accu-Chek Aviva
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Shelf Life Stability | Not explicitly stated, but expected to meet the claimed shelf life. | Supports a shelf life of 24 months when stored at 15-30°C. |
| Open Vial Stability | Not explicitly stated, but expected to meet the claimed open vial stability. | Supports an open vial stability of 90 days when stored at 15-30°C. |
| Test Precision | Not explicitly stated. The document states "No precision claims will be made for this product." | Studies performed per CLSI document EP5-A2: 2004. No precision claims made. |
| Value Assignment | Acceptable ranges based on "predetermined acceptance criteria established by the manufacturer for glucose recovery for each lot." | The control solutions are analyzed using a single AVIVA monitor using three different lots of test strips, 10 replicates per strip lot, over three days. Glucose control value ranges are lot-dependent and printed on the vial label. |
| Traceability | Not explicitly stated, but expected to be traceable to a recognized standard. | Traceable to an in-house 45 mg/dL Standard, which is traceable to NIST Standard Reference Material 917b. |
| Substantial Equivalence (Overall) | The device's performance characteristics, formulation, and intended use must be substantially equivalent to the predicate device. | Comparison of performance characteristics, formulation, and intended use support the claim of substantial equivalence to the predicate device (ACCU-CHEK Aviva Control Level 1, K043474). |
2. Sample Size Used for the Test Set and Data Provenance
- Real Time Stability: "Samples were periodically removed and tested in triplicate..." The total number of samples or distinct time points is not specified.
- Open Vial Stability: "A number of test and control vials were evaluated for 13 weeks. Each week one test group vial was assayed and one control group vial was assayed in triplicate..." The exact "number of test and control vials" is not specified, but the evaluation spanned 13 weeks with weekly testing of one vial from each group.
- Value Assignment: "using three different lots of test strips, 10 replicates per strip lot, over three days." (This means 3 lots * 10 replicates = 30 measurements for value assignment.)
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that Fujirebio Diagnostics, Inc. is located in Seguin, TX, USA, it's reasonable to infer the studies were conducted in the US. The nature of these stability and performance verification studies suggests they were prospective, carried out specifically for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies described are analytical performance studies of a control solution, which typically do not involve human expert interpretation for "ground truth" in the same way an imaging or diagnostic AI would. The "ground truth" here is the measured glucose concentration, either by a clinical chemistry analyzer or the Accu-Chek Aviva meter itself, as calibrated to a reference standard.
4. Adjudication Method for the Test Set
This is not applicable as the studies described are analytical performance tests for a control solution, not studies requiring human expert judgment or adjudication (e.g., for disease diagnosis).
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
There was no MRMC comparative effectiveness study done. This device is a glucose control solution, not an AI-powered diagnostic device that would assist human readers in interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the context of this device. The "device" itself is the control solution. The performance studies evaluate the control solution's stability and its interaction with the Accu-Chek Aviva meter. The meter itself operates in a "standalone" fashion (algorithm only) when it measures glucose, but the control solution is a reagent for quality control, not an algorithm.
7. The Type of Ground Truth Used
- For Stability Studies (Real Time & Open Vial): The ground truth was established by testing samples in triplicate on a "commercially available clinical chemistry analyzer." This implies a reference method or gold standard laboratory measurement for glucose concentration.
- For Value Assignment: The control is traceable to an in-house 45 mg/dL Standard, which is traceable to NIST Standard Reference Material 917b. This indicates a chemically certified reference standard as the ultimate ground truth for glucose concentration.
8. The Sample Size for the Training Set
This is not applicable as the FDI Glucose Control Solution is a physical control solution, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
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510(k) Premarket Notification: FDI Glucose Control for Aviva Plus Fujirebio Diagnostics, Inc.
:
| 5 | 510(k) Summary | |
|---|---|---|
| --- | -- | ---------------- |
JAN 1 7 2013
.
:
| 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.940 Crossroads BlvdSeguin, TX 78155(830) 372-1391 ex. 210Establishment Registration Number: 1643621 |
| Contact Person: | Kent Pruett |
| Device Name: | FDI Glucose Control Solution for use with Accu-ChekAviva |
| Common Name: | Single Analyte Control Solution, All Types (Assayedand Unassayed) |
| Classification Name: | Quality Control Material (assayed and unassayed). |
| Classification: | Class I,per 21 CFR 862.1660Reserved |
| Product Code: | 75 JJX |
| Panel: | Chemistry |
| Predicate Devices: | Name: ACCU-CHEK Aviva Control Level 1Manufacturer: Roche Diagnostics510(k) No.: K043474 |
| Device Description: | The FDI Glucose Control Solution for Aviva consistsof a viscosity-adjusted, aqueous liquid control solutioncontaining a known quantity of glucose. The productis packaged in plastic dropper tipped bottles for easyapplication of the control solutions to the test stripsand a red coloration to aid the user to visually confirmapplication of the control. The product is non-hazardous and contains no human or animal derivedmaterials. |
| Intended Use: | The FDI Glucose Control Solution is intended for usewith Aviva Plus test strip when used on the Accu-Chek® Aviva blood glucose meter. The control |
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solution is used with the Aviva Plus test strips to check that the meter and test strips are working together properly.
Comparison to Predicate Devices:
| Characteristic/Aspect | Predicate Device No. 1 | New Product |
|---|---|---|
| Name | ACCU-CHEK Aviva ControlLevel 1 | FDI Glucose ControlSolution for Accu-ChekAviva |
| 510(k), Date | K04347404/27/2005 | |
| Number ofLevels | 1 | 1 |
| Analyte | Glucose | Glucose |
| Target Range(mg/dL) | $25 - 55^{(2)}$ | $23 - 53^{(1)}$ |
| Container | Plastic bottle withdropper-tip | Plastic bottle withdropper-tip |
| Fill Volume | 2.5 mL | 3.6 mL |
| Color | Blue | Red |
| Matrix | Glucose, buffer, salts,non-reactive ingredients,preservative, FD & CBlue #1 | Water, D-Glucose, aviscosity modifier, buffer,salt, preservatives, andFD&C Red #40 |
| Indications forUse | Checks that the meterand test strips areworking properly to givereliable results. | The FDI Glucose ControlSolution is intended foruse with Aviva Plus teststrip when used on theAccu-Chek® Aviva bloodglucose meter. Thecontrol solution is usedwith the Aviva Plus teststrips to check that themeter and test strips areworking togetherproperly. |
| TargetPopulation | Professional and homeuse | Professional and homeuse |
(1) Based on a +/- 5% glucose concentration variability lot-to-lot and +/- 15 mg/dl range (2)Derived from the control ranges assigned by the manufacturer
Performance Studies: Tests were performed to verify specific performance characteristics:
- Real Time Stability: Samples were periodically removed and tested in triplicate on a commercially available clinical chemistry analyzer. The study supports a shelf life of 24 months when stored at 15-30°C.
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510(k) Premarket Notification: FDI Glucose Control for Aviva Plus Fujirebio Diagnostics, Inc.
- Open Vial Stability: A number of test and control vials were evaluated for 13 weeks. Each day all vials were opened, allowed to stand for ten minutes, then closed and stored at room temperature. Each week one test group vial was assayed and one control group vial was assayed in triplicate using the ACE Glucose assav. The Control vial was opened on the date of performing the assay and then discarded after testing was complete. The study supports the claimed open vial stability of 90 days when stored at 15 - 30℃.
- Test Precision: Studies performed per CLSI Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition. CLSI document EP5-A2: 2004. No precision claims will be made for this product.
- Value Assignment: The control solutions are analyzed using a single AVIVA monitor using three different lots of test strips, 10 replicates per strip lot, over three days. Acceptable ranges are based on predetermined acceptance criteria established by the manufacturer for glucose recovery for each lot. The glucose control value ranges are lot dependent; therefore the range for each lot is printed on the control solution vial label.
- Traceability: The control is traceable to an in-house 45 mg/dL Standard traceable to the NIST Standard Reference Material 917b. The inhouse 45 mg/dL Standard is produced using SRM917.
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 U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 17, 2012
Fujirebio Diagnostics, Inc. c/o Kent Pruett 940 Crossroads Blvd. Seguin, TX 78155
Re: K123612
Trade/Device Name: FDI Glucose Control Solution for use with Accu-Chek Aviva Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: I. reserved . Product Code: JJX Dated: November 23, 2012 Received: December 20, 2012
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. Pruett
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Medica]Devices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Ruth A. Chesler
Courtney H. Lias, Ph.D
Director, Division of Chemistry and Toxicology Devices
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123612
Device Name: FDI Glucose Control Solution for use with Accu-Chek Aviva
Indications For Use: The FDI Glucose Control Solution is intended for use with Aviva Plus test strip when used on the Accu-Chek® Aviva blood glucose meter. The control solution is used with the Aviva Plus test strips to check that the meter and test strips are working together properly.
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)
Katherine Serrano 2013.01.17 13:04:13 -05'00'
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
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§ 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.