(64 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 Accu-Chek Aviva Blood Glucose Monitor.
The FDI Glucose Control 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.
The information provided describes the FDI Glucose Control for Aviva, a quality control solution for the Accu-Chek Aviva Blood Glucose Monitor. As a control solution, its purpose is to ensure the proper functioning of the blood glucose meter. The available document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trial data that would typically feature in a drug approval or a more complex medical device requiring novel clinical evidence.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner as you might see for a diagnostic's sensitivity and specificity. Instead, the performance studies for this control solution are based on stability and precision, and the comparison to the predicate device.
| Performance Characteristic | Predicate Device Acceptance/Performance (ACCU-CHEK Aviva Control Level 1) | New Product Performance (FDI Glucose Control for Aviva) | Stated Outcome |
|---|---|---|---|
| Analyte | Glucose | Glucose | Equivalent |
| Target Range (mg/dL) | 25 - 55 (Derived from manufacturer's assigned ranges) | 19 - 51 (Based on +/- 5% glucose variability lot-to-lot and +/- 15 mg/dL range) | Comparable |
| Number of Levels | 1 | 1 | Equivalent |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip | Equivalent |
| Fill Volume | 2.5 mL | 3.6 mL | Different |
| Color | Red | Red | Equivalent |
| Matrix | Glucose, buffer, salts, non-reactive ingredients, preservative, FD & C Blue #1 | Buffered aqueous solution of D-Glucose, a viscosity modifier, preservatives, and other non-reactive ingredients | Similar |
| Intended Use | To check that the meter and test strips are working properly to give reliable results. | To check the performance of the ACCU-CHEK Aviva Blood Glucose System. | Equivalent |
| Target Population | Professional and home use | Professional and home use | Equivalent |
| Real Time Stability | Not explicitly stated for predicate in comparison table | Tests performed to verify specific performance | Claimed equivalent |
| Open Vial Stability | Not explicitly stated for predicate in comparison table | Tests performed to verify specific performance | Claimed equivalent |
| Test Precision | Not explicitly stated for predicate in comparison table | Tests performed to verify specific performance | Claimed equivalent |
The "Conclusion" section explicitly states: "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence." This implies that the performance in stability and precision tests was considered acceptable and comparable to the predicate device. However, specific numerical acceptance criteria for these tests are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size for the test set, nor does it specify the data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) summary for a control solution, where the focus is on chemical and physical properties rather than large-scale clinical trials involving patient data.
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)
This product is a control solution for a blood glucose monitor. The "ground truth" for such a device would typically be established by analytical chemistry methods to determine the precise glucose concentration within the control solution itself. This generally involves skilled laboratory technicians or chemists using reference methods, not clinical experts like radiologists. The document does not mention the number or qualifications of experts for establishing the ground truth of the control solution's glucose concentration.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where subjective interpretations (e.g., image reads) require consensus among experts. For a control solution, performance is assessed based on objective analytical measurements (stability, precision, glucose concentration). Therefore, an adjudication method is not applicable and not mentioned.
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
An MRMC study is not applicable to a control solution. This type of study involves human readers (e.g., radiologists) interpreting cases, often with or without AI assistance, to assess diagnostic performance. The FDI Glucose Control for Aviva is a laboratory reagent used to verify the accuracy of a blood glucose meter, not a device that human readers interpret.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The FDI Glucose Control for Aviva is a physical solution; it does not contain an algorithm in the sense of AI or software that operates independently to produce a diagnostic output. Its "performance" is its intrinsic chemical stability and ability to elicit a correct response from the Accu-Chek Aviva meter within expected ranges.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for a glucose control solution would be the actual, analytically determined concentration of glucose within the solution. This is established through rigorous laboratory testing using highly accurate and precise reference methods (e.g., isotope dilution mass spectrometry, enzymatic reference methods). The document does not explicitly state the specific method used to establish this inherent "ground truth" for the control solution, but it is implied by the nature of the product. The stated "Target Range (mg/dL)" for the new product (19-51 mg/dL) is "Based on a +/- 5% glucose concentration variability lot-to-lot and +/- 15 mg/dl range," indicating that the underlying glucose concentration is analytically defined.
8. The sample size for the training set
This question is not applicable as the FDI Glucose Control for Aviva is a chemical control solution, not an AI/ML algorithm or a device that requires a "training set" in the computational sense. Its performance is based on its chemical properties and manufacturing consistency.
9. How the ground truth for the training set was established
As there is no "training set" for this type of device, this question is not applicable.
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510(k) Premarket Notification: FDI Glucose Control for Aviva Fujirebio Diagnostics, Inc. ·
APR 2 0 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.940 Crossroads BlvdSeguin, TX 78155(830) 372-1391 ex. 210Establishment Registration Number: 1643621 | ||
| Contact Person: | Kent Pruett | ||
| Device Name: | FDI Glucose Control for Aviva | ||
| 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: | ACCU-CHEK Aviva Control Level 1 | |
| Manufacturer: | Roche Diagnostics | ||
| 510(k) No.: | K043474 | ||
| Device Description: | The FDI Glucose Control for Aviva consists of aviscosity-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 for Aviva is intended for invitro diagnostic use (i.e. for external use only) byhealthcare professionals and in the home by people |
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510(k) Premarket Notification: FDI Glucose Control for Aviva Fujirebio Diagnostics, Inc.
with diabetes mellitus to assess the performance of Accu-Cнeк Aviva Blood Glucose Monitor.
Comparison to Predicate Devices:
| Characteristic/Aspect | Predicate Device No. 1 | New Product |
|---|---|---|
| Name | ACCU-CHEK Aviva Control Level 1 | FDI Glucose Control for Aviva |
| 510(k), Date | K04347404/27/2005 | |
| Number of Levels | 1 | 1 |
| Analyte | Glucose | Glucose |
| Target Range (mg/dL) | 25 - 55(1) | 19 - 51(2) |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip |
| Fill Volume | 2.5 mL | 3.6 mL |
| Color | Red | Red |
| Matrix | Glucose, buffer, salts, non-reactive ingredients,preservative, FD & C Blue #1 | Buffered aqueous solution of D-Glucose, a viscosity modifier,preservatives, and other non-reactive ingredients |
| Indications for Use | Checks that the meter and teststrips are working properly togive reliable results. | To check the performance of theACCU-CHEK Aviva Blood GlucoseSystem. |
| Target Population | Professional and home use | Professional and home use |
(1)Derived from the control ranges assigned by the manufacturer.
on ESTATUS and the Sent of ranges assigned by the manufacturer.
(2)Based on a +/- 5% glucose concentration variability lot-to-lot and +/- 15 mg/dl range
, !
Performance Studies: characteristics:
Tests were performed to verify specific performance
-
- Real Time Stability
-
- Open Vial Stability
-
- Test precision
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Fujirebio Diagnostics, Inc. c/o Kent Pruett Director of Quality and Regulatory Affairs 940 Crossroads Blvd. Seguin, TX 78155
APR 2 0 2011
Re: K110436 Trade Name: FDI Glucose Control Solution for Aviva Regulation Number: 21 CFR 862.1660 Regulation Name: single (specified) analyte controls (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: February 8, 2011 Received: February 15, 2011
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 (1 wr 1), it may obedoged 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 I vactar agencier - comments on 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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510(k) Premarket Notification: FDI Glucose Control for Aviva Fujirebio Diagnostics, Inc.
4 Indications for Use Statement
510(k) Number (if known): K110436
Device Name: FDI Glucose Control for Aviva
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 performononals the Aviva 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)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110436
§ 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.