(132 days)
RNA Medical® Brand Glucose and ß-Ketone Calibration Verification Controls are assayed materials for confirming the calibration and linearity of glucose and ß-ketone at the upper and lower limits of the reportable range and at three (3) points within the range. This product is for use with the Precision Xceed Pro Blood Glucose and ß-ketone Monitoring System, which uses Precision Xceed Pro Blood Glucose Test Strips and Precision Xceed Pro Blood B-Ketone Test Strips. It is not for use with the Precision PCx System or the i-STAT® 1 Analyzer, which use Precision PCx Test Strips, Precision PCx Plus Test Strips, or i-STAT 1 glucose cartridges.
RNA Medical Glucose and ß-Ketone Calibration Verification Controls is intended for use by healthcare professionals.
For In Vitro Diagnostic Use
RNA Medical Glucose and ß-Ketone Calibration Verification Controls is a five-level. viscosity-adjusted, aqueous liquid glucose and ß-ketone control linearity set optimized for use with the Abbott Diabetes Care Precision Xceed Pro™ Blood Glucose and B-Ketone Monitoring System using Precision Xceed Pro Blood Glucose Test Strips and Precision Xceed Pro Blood β-Ketone Test Strips. RNA Medical Glucose and β-Ketone Calibration Verification Controls provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as 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.
RNA Medical Glucose and β-Ketone Calibration Verification Controls contains glucose and ketone 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 of the blood glucose and blood ketone systems listed on the package insert.
This material is comprised of an aqueous solution of glucose (0.03% - 0.40%), β-hydroxybutyrate (0.01% - 0.12%), and non-reactive ingredients (viscosity enhancing agent, dye, buffer, and preservative) prepared in five specific glucose and ketone concentrations. These controls contain no hazardous or human biological materials.
Acceptance Criteria and Study for RNA Medical Glucose and ß-Ketone Calibration Verification Controls
Based on the provided document, the "RNA Medical Glucose and ß-Ketone Calibration Verification Controls" is a control product used to assess the performance of a blood glucose and β-ketone monitoring system, not an AI device. As such, the typical metrics and study designs applicable to AI/ML medical devices (e.g., sensitivity, specificity, MRMC studies, standalone performance) are not relevant here.
Instead, the acceptance criteria and supporting studies focus on the stability and accuracy of the control solution itself, ensuring it provides reliable and consistent reference points for calibration verification and linearity testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in a quantitative table format for performance metrics. Instead, it describes "specific performance requirements" that were verified. The reported device performance is presented as the intended target values for the different levels of the control.
Here's an interpretation of the implied acceptance criteria and the device's reported performance (target values):
| Performance Requirement (Implied Acceptance Criteria) | Reported Device Performance (Target Midpoint Values) |
|---|---|
| Closed bottle stability | Demonstrated stability for the specified shelf-life. (Specific duration not detailed in this summary, but verified.) |
| Use-life stability (after opening) | Demonstrated stability for the specified period after opening. (Specific duration not detailed in this summary, but verified.) |
| Test mean response | Control levels produce consistent and predictable mean responses within acceptable ranges on the target device. (See target values below). |
| Precision data | Control levels demonstrate appropriate precision (reproducibility) when tested on the target device. (Specific values for precision not detailed in this summary, but verified.) |
| Glucose Target Values | Level 1: 25 mg/dL; Level 2: 97 mg/dL; Level 3: 260 mg/dL; Level 4: 347 mg/dL; Level 5: 444 mg/dL |
| Ketone Target Values | Level 1: 0.4 mmol/L; Level 2: 1.1 mmol/L; Level 3: 2.4 mmol/L; Level 4: 3.6 mmol/L; Level 5: 5.1 mmol/L |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a "test set" sample size in terms of patient data or clinical samples, as this is a control solution, not a diagnostic device directly analyzing patient samples. The testing involved multiple measurements of the control solution itself. The exact number of runs or samples per stability or precision study is not detailed in this summary.
- Data Provenance: Not applicable in the context of patient data for a control solution. The data would originate from laboratory testing performed internally by the manufacturer (Bionostics, Inc.) during product development and validation. The country of origin for the testing would presumably be the USA (Devens, MA), where the company is located. The studies would be prospective in nature, as they involve testing the newly developed control solution.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For a control solution like this, the "ground truth" for the test set is established by precise chemical formulation and analytical testing, not by expert interpretation of images or clinical cases.
- Qualifications of Experts: N/A. The "experts" involved would be analytical chemists, quality control specialists, and metrologists responsible for formulating the controls and verifying their concentrations using established laboratory methods and traceable standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication typically refers to resolving discrepancies between multiple human readers or between human readers and an AI system for clinical assessments. For a chemical control, the "truth" is determined by objective analytical measurements and verified against established chemical standards to ensure the stated concentration levels are correct.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation or clinical decision-making) where human performance is compared to human performance with AI assistance. The RNA Medical Glucose and ß-Ketone Calibration Verification Controls are calibration and linearity controls, not a diagnostic device.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: No, a standalone performance study was not done. This type of study is relevant for AI algorithms to assess their performance without human intervention. The device in question is a chemical control solution, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the control solution's values (glucose and ß-ketone concentrations) is established through analytical chemistry and metrology. This involves precise formulation and quantitative measurement using highly accurate reference methods and traceable standards to determine the exact concentration of glucose and ß-hydroxybutyrate in each level of the control. The manufacturer refers to an internal document "EDMS014536 Rev. 001, Summary of Expected G3CH And Ketones II Values for Bionostics Calibration Verification Control Solutions," which would contain these detailed analytical ground truth values.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a chemical control solution, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As there is no training set for an AI algorithm, there is no ground truth to be established for it. The ground truth for the control product itself is established through precise chemical formulation and analytical validation during manufacturing.
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OCT 0 6 2008
page 1 of 3
510(k) Summ
- (a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road
Devens, MA 01434
Contact Person Kathleen Storro Sr. Dir. QA/RA (978) 772-7070 x 220
Date of preparation of this summary:
23 May 2008
(2) Device trade or proprietary name: RNA Medical Glucose and B-Ketone Calibration Verification Controls
Device common or usual name or classification name:
JJY, Multi-Analyte Controls, all Kinds (assayed)
| PRODUCT NOMENCLATURE | CLASSIFICATIONNUMBER | CLASS | PANEL |
|---|---|---|---|
| MULTI-ANALYTE CONTROL SOLUTION | 862.1660 | I | 75 CLINICAL CHEMISTRY |
l. Substantial Equivalence
RNA Medical Glucose and β-Ketone Calibration Verification Controls is substantially equivalent in function, safety and efficacy to currently marketed devices for the same intended use:
Comparison of RNA Medical Glucose and ß-Ketone Calibration Verification Controls to predicate devices for substantial equivalency
| Characteristic | Predicate Devices | Modified Device | |
|---|---|---|---|
| Name: | RNA GL4 GlucoseCalibration VerificationControl | Precision ControlSolutions | RNA Medical Glucose andβ-Ketone CalibrationVerification Controls |
| 510(k), Date: | KO21624, July 12, 2002 | K983504, July 9, 1999 | |
| Number of levels: | 5**7 vials per kit, only 5levels for use on specificdevices | 3 | 5 |
| Analytes: | Glucose | Glucose, Ketone | Glucose, Ketone |
| Container: | plastic bottle | plastic bottle | plastic bottle |
| Fill volume: | 4 mL | 3 mL | 4 mL |
| Color: | Red | Clear | Red |
| Matrix: | Buffered aqueoussolution of D-Glucose,viscosity modifier, dye,preservative and othernon-reactiveingredients. | Buffered aqueoussolution of D-Glucose,Beta-hydroxybutyrateand other non-reactiveingredients. | Buffered aqueoussolution of D-Glucose, β-hydroxybutyrate,viscosity modifier, dye,preservative and othernon-reactive ingredients. |
2 This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
7 Jackson Road Devens, MA USA 01434 · (978) 772-7070 · Fax: (978) 772-7072 .
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II. Description of the new device
RNA Medical Glucose and ß-Ketone Calibration Verification Controls is a five-level. viscosity-adjusted, aqueous liquid glucose and ß-ketone control linearity set optimized for use with the Abbott Diabetes Care Precision Xceed Pro™ Blood Glucose and B-Ketone Monitoring System using Precision Xceed Pro Blood Glucose Test Strips and Precision Xceed Pro Blood β-Ketone Test Strips. RNA Medical Glucose and β-Ketone Calibration Verification Controls provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as 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.
RNA Medical Glucose and β-Ketone Calibration Verification Controls contains glucose and ketone 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 of the blood glucose and blood ketone systems listed on the package insert.
| Target midpoint values for Precision Xceed Pro Blood Glucose Test Strips and | |
|---|---|
| Precision Xceed Pro Blood ß-Ketone Test Strips3 |
| Analyte | Strip Type | Units | Level 1 | Level 2 | Level 3 | Level 4 | Level 5 |
|---|---|---|---|---|---|---|---|
| Glucose | Precision Xceed Pro BloodGlucose Test Strip | mg/dL | 25 | 97 | 260 | 347 | 444 |
| Ketone | Precision Xceed Pro BloodB-Ketone Test Strip | mmol/L | 0.4 | 1.1 | 2.4 | 3.6 | 5.1 |
RNA Medical Glucose and β-Ketone Calibration Verification Control is nonhazardous aqueous solution containing no biological materials.
(5) Intended use of the device
RNA Medical Glucose and β-Ketone Calibration Verification Control is intended to confirm the calibration and linearity of glucose and ß-ketone of the Abbott Diabetes Care Precision Xceed Pro™ Blood Glucose and β-Ketone Monitoring System by healthcare professionals.
(6) Technological characteristics of the device.
This material is comprised of an aqueous solution of glucose (0.03% - 0.40%), β-hydroxybutyrate (0.01% - 0.12%), and non-reactive ingredients (viscosity enhancing agent, dye, buffer, and preservative) prepared in five specific glucose and ketone concentrations. These controls contain no hazardous or human biological materials.
3 EDMS014536 Rev. 001, Summary of Expected G3CH And Ketones II Values for Bionostics Calibration Verification Control Solutions
510(k) PREMARKET NOTIFICATION - RNA Medical Glucose and β-Ketone Calibration Verification Controls
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-
Summary of non-clinical tests submitted with the premarket notification for the (b) (1) device.
Tests were conducted to verify specific performance requirements: -
a) Closed bottle stability
-
b) Use-life stability (stability after opening)
-
c) Test mean response and precision data
-
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features 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 eagle is drawn with thick, black lines, and the text is in a smaller, sans-serif font.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 0 6 2008
Bionostics, Inc. c/o Ms. Kathleen Storro Senior Director of Quality Affairs/ Regulatory Affairs 7 Jackson Road Devens, MA 01434
Re: K081478
Trade Name: RNA Medical Glucose and ß-Ketone Calibration Verification Controls Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: September 10, 2008 Received: September 12, 2008
Dear Ms. Storro:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10(L) marketed predicate device results in a classification for your device and this, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli the (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. 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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Indication for Use
510(k) Number (if known): K081478
Device Name: RNA Medical Glucose and ß-Ketone Calibration Verification Controls
Indication For Use:
RNA Medical® Brand Glucose and ß-Ketone Calibration Verification Controls are assayed materials for confirming the calibration and linearity of glucose and ß-ketone at the upper and lower limits of the reportable range and at three (3) points within the range. This product is for use with the Precision Xceed Pro Blood Glucose and ß-ketone Monitoring System, which uses Precision Xceed Pro Blood Glucose Test Strips and Precision Xceed Pro Blood B-Ketone Test Strips. It is not for use with the Precision PCx System or the i-STAT® 1 Analyzer, which use Precision PCx Test Strips, Precision PCx Plus Test Strips, or i-STAT 1 glucose cartridges.
RNA Medical Glucose and ß-Ketone Calibration Verification Controls is intended for use by healthcare professionals.
For In Vitro Diagnostic Use
Prescription Use______________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081478
§ 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.