(27 days)
Multi-Meter Glucose Calibration Verification Material assayed controls are intended for use to verify the performance of multiple blood glucose meters as indicated on the package insert at their upper and lower ends of reportable range and at three points within the range. These controls can therefore be used to assess the linearity and calibration of the test system, or to verify the test systems' performance. For In Vitro Diagnostic Use
Multi-Meter Glucose Calibration Verification Material is a five-level, viscosityadjusted, aqueous liquid glucose control linearity set. Multi-Meter Glucose Calibration Verification Material provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip. Multi-Meter Glucose Calibration Verification Material contains glucose values at the lower and upper limits of reportable range as well as three points within the range and therefore, may be used to assess the linearity and calibration, or verify performance, for each of a number of blood glucose meters listed on the package insert. Multi-Meter Glucose Calibration Verification Material is a non-hazardous aqueous solution containing no biological materials.
Here's an analysis of the provided text regarding the Bionostics Multi-Meter Glucose Calibration Verification Material, focusing on acceptance criteria and study details:
Device: Bionostics Multi-Meter Glucose Calibration Verification Material
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for K012430 does not explicitly state specific quantitative acceptance criteria for the Multi-Meter Glucose Calibration Verification Material. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through qualitative and common performance characteristics.
However, based on the non-clinical tests conducted, we can infer the types of performance attributes that would have been evaluated to meet implied acceptance criteria.
| Acceptance Criteria Category (Inferred) | Reported Device Performance |
|---|---|
| Stability (Shelf-life) | Supported by accelerated aging studies on most labile analytes and experience with similar formulations. (Specific timeframes or limits not provided). |
| Precision | Test precision was evaluated. (Specific precision values or limits not provided). |
| Correlation to Reference Methodology | Correlation to reference methodology was evaluated. (Specific correlation coefficients or limits not provided). |
| Linearity/Calibration Verification | Contains glucose values at lower/upper reportable range and three points within, suitable for assessing linearity and calibration. |
| Simulated Whole Blood Response | Optimized to simulate whole blood response on listed blood glucose meters. |
| Safety (Non-hazardous) | Non-hazardous aqueous solution, no biological materials. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of human data or a specific dataset for performance evaluation. Instead, it refers to "non-clinical tests" to verify performance requirements.
- Sample Size for Test Set: Not explicitly stated. The tests conducted were likely laboratory-based experiments involving multiple samples of the material itself, measured across various glucose meters.
- Data Provenance: The studies were non-clinical (laboratory-based) and were conducted by Bionostics, Inc. in Acton, MA, USA. The data is retrospective in the sense that it was collected prior to the 510(k) submission. There is no mention of country of origin for patient data as this is a control material, not a diagnostic device directly interacting with patient samples for primary diagnosis.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the submission. The device is a calibration verification material, and its "ground truth" would be established by the known, certified glucose concentration levels within the material itself, as measured by a reference method, not by expert interpretation of images or patient data.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of results (e.g., radiology images) by multiple experts. For a control material, the "assessment" is based on analytical measurements against known values and technical specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. The Bionostics Multi-Meter Glucose Calibration Verification Material is a laboratory control solution, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only) Performance Study was Done
No, a standalone (algorithm only) performance study was not done. This device is a control material, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for this device would be established by:
- Reference Methodology: The concentrations of glucose in the five levels of the control material would be accurately measured and verified using a highly accurate and precise reference method (e.g., enzymatic reference methods traceable to standard reference materials).
- Formulation Specifications: The ground truth for stability and other characteristics would be tied to the chemical formulation and manufacturing specifications to ensure consistent and accurate glucose levels.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a chemical control solution, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided, as there is no "training set" for this type of device.
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BIONOSTICS
AUG 2 7 2001
510(k) Summary*
- Submitter's name, address (a) (1) Bionostics, Inc. 2 Craig Road Acton, MA 10720
Contact Person Kathleen Storro Director, QA & Regulatory Affairs (978) 263-3856 x 220
Date of preparation of this summary: 27 July 2001
- Device trade or proprietary name: (2)
Multi-Meter Glucose Calibration Verification Material
Device common or usual name or classification name:
Multi Analyte Control Solution, All Types (Assayed and Unassayed)
| PRODUCT NOMENCLATURE | NUMBER | CLASS | PANEL |
|---|---|---|---|
| SINGLE ANALYTE CONTROL SOLUTION | 862.1660 | I | CHEMISTRY |
| 75 JJX |
Substantial Equivalence (3)
Multi Analyte Glucose Calibration Verification Material is substantially equivalent in function, safety and efficacy to currently marketed devices produced by Bionostics. In example:
Comparison of Multi-Meter Glucose Calibration Verification Material to predicate devices for substantial equivalency
| Characteristic | Predicate Devices | Predicate Devices | Modified Device |
|---|---|---|---|
| Name: | Sugar Chex Linearity forOne Touch | Quality Control Solutionfor MediSense BGM | Multi-Meter GlucoseCalibration VerificationMaterial |
| 510(k), Date: | K925479, 01/29/93 | K002540, 09/18/2000 | |
| Number of levels: | 5 | 5 | 5 |
| Analytes: | Glucose | Glucose | Glucose |
| Container: | plastic bottle | plastic bottle | plastic bottle |
| Fill volume: | 2 mL | 4 mL | 4 mL |
| Color: | red | red | red |
| Matrix: | Stabilized human redblood cells with glucosein a medium withperservatives. | Buffered, aqueoussolution of D-Glucose,viscosity modifier,preservatives and other,non-reactive ingredients. | Buffered, aqueoussolution of D-Glucose,viscosity modifier,preservatives and other,non-reactive ingredients. |
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
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- Description of the new device (4)
Multi-Meter Glucose Calibration Verification Material is a five-level, viscosityadjusted, aqueous liquid glucose control linearity set. Multi-Meter Glucose Calibration Verification Material provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips. The control has a red color to help users see the solution while dispensing onto a test strip.
Multi-Meter Glucose Calibration Verification Material contains glucose values at the lower and upper limits of reportable range as well as three points within the range and therefore, may be used to assess the linearity and calibration, or verify performance, for each of a number of blood glucose meters listed on the package insert.
Multi-Meter Glucose Calibration Verification Material is a non-hazardous aqueous solution containing no biological materials.
-
(5) Intended use of the device
Multi-Meter Glucose Calibration Verification Material is intended to be used to monitor and evaluate the analytical performance of a number of popular blood glucose meters (BGM) as listed in the package insert .. -
Technological characteristics of the device. (6)
This material consists of viscosity-adjusted, aqueous glucose control solutions prepared in five specific glucose concentrations. The solutions have been optimized to simulate the response of whole blood on a number of blood glucose meters listed in the package insert.
Summary of non-clinical tests submitted with the premarket notification for the (b) (1) device.
Tests were conducted to verify specific performance requirements:
- a) Accelerated aging studies on most labile analytes, together with experience with other products with similar formulations support stability claim.
- b) Test precision
- c) Correlation to reference methodology
- Summary of clinical tests submitted with the premarket notification for the device. (b) (2) N/A
- Conclusions drawn from the clinical and non-clinical trials. (b) (3) Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.
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Image /page/2/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 coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 7 2001
Ms. Kathleen Storro Director, QA and Regulatory Affairs Bionostics, Inc. 2 Craig Road Acton, MA 01720
Re: K012430
Trade/Device Name: Multi-Meter Glucose Calibration Verification Material Regulation Number: 21 CFR 862.1660 Regulatory Class: I, reserved Product Code: JJX Dated: July 27, 2001 Received: July 31, 2001
Dear Ms. Storro:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: Ko12430
Multi-Meter Glucose Calibration Verification Material Device Name:
Indications for Use:
Multi-Meter Glucose Calibration Verification Material assayed controls are intended for use to verify the performance of multiple blood glucose meters as indicated on the package insert at their upper and lower ends of reportable range and at three points within the range. These controls can therefore be used to assess the linearity and calibration of the test system, or to verify the test systems' performance.
For In Vitro Diagnostic Use
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| -------------------------------------------------------- |
| Prescription Use (Per 21 CFR 801.109) | ✓ |
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| --------------------------------------- | ------------------------------------------------------------------------------------------ |
| OR | Over-The-Counter Use | |
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| -- | ---- | ---------------------- |
| (Optional Format 1-2-96) | ||
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| -- | -- | -------------------------- |
| Kesia Alexander for Sean Cuppex(Division Sign-Off) | |
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| -- | ---------------------------------------------------------------------- |
Division of Clinical Laboratory Devices
| 510(k) Number | K017430 |
|---|---|
| --------------- | ---------------------------------------------------------- |
§ 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.