(132 days)
KO21624, K983504
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No
The document describes calibration verification controls, which are passive materials used to check the performance of a glucose and ketone monitoring system. There is no mention of any computational or analytical capabilities within the control material itself, let alone AI or ML.
No
This device is a calibration verification control used to confirm the accuracy and linearity of glucose and ß-ketone monitoring systems, not for diagnosis, cure, mitigation, treatment, or prevention of disease. It is for "In Vitro Diagnostic Use".
No.
This device is described as "Calibration Verification Controls," "assayed materials for confirming the calibration and linearity of glucose and ß-ketone," and a "liquid glucose and ß-ketone control linearity set." Its purpose is to verify the performance of other monitoring systems, not to directly diagnose a patient's condition. The text explicitly states, "RNA Medical Glucose and ß-Ketone Calibration Verification Controls is intended for use by healthcare professionals," and "For In Vitro Diagnostic Use," but this refers to its use in the context of in vitro diagnostics to ensure the accuracy of diagnostic devices, not as a diagnostic device itself.
No
The device is a liquid control solution used for calibrating and verifying glucose and ß-ketone monitoring systems. It is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use".
- Intended Use: The device is intended for "confirming the calibration and linearity of glucose and ß-ketone" using a specific monitoring system and test strips. This is a diagnostic purpose, as it helps ensure the accuracy of the system used to measure analytes in a biological sample (blood).
- Device Description: The description details the composition of the control solution, which is an "aqueous solution of glucose and β-hydroxybutyrate" with other non-reactive ingredients. This material is designed to be used in vitro (outside the body) with the monitoring system.
- Predicate Devices: The listed predicate devices (K021624, RNA GL4 Glucose Calibration Verification Control; K983504, Precision Control Solutions) are also IVD devices, indicating the regulatory classification of similar products.
Therefore, based on the explicit statement and the intended use and nature of the device, it is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RNA Medical Glucose and β-Ketone Calibration Verification Control is intended to confirm the calibration and linearity of glucose and β-ketone of the Abbott Diabetes Care Precision Xceed Pro™ Blood Glucose and β-Ketone Monitoring System by healthcare professionals.
RNA Medical® Brand Glucose and β-Ketone Calibration Verification Controls are assayed materials for confirming the calibration and linearity of glucose and β-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 β-ketone Monitoring System, which uses Precision Xceed Pro Blood Glucose Test Strips and Precision Xceed Pro Blood β-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.
Product codes (comma separated list FDA assigned to the subject device)
JJY, JJX
Device Description
RNA Medical Glucose and β-Ketone Calibration Verification Controls is a five-level, viscosity-adjusted, aqueous liquid glucose and β-ketone control linearity set optimized for use with the Abbott Diabetes Care Precision Xceed Pro™ Blood Glucose and β-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.
RNA Medical Glucose and β-Ketone Calibration Verification Control is nonhazardous aqueous solution containing no biological materials.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KO21624, K983504
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 | CLASSIFICATION
NUMBER | 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 Glucose | ||
| Calibration Verification | |||
| Control | Precision Control | ||
| Solutions | RNA Medical Glucose and | ||
| β-Ketone Calibration | |||
| Verification Controls | |||
| 510(k), Date: | KO21624, July 12, 2002 | K983504, July 9, 1999 | |
| Number of levels: | 5* | ||
| *7 vials per kit, only 5 | |||
| levels for use on specific | |||
| devices | 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 aqueous | ||
| solution of D-Glucose, | |||
| viscosity modifier, dye, | |||
| preservative and other | |||
| non-reactive | |||
| ingredients. | Buffered aqueous | ||
| solution of D-Glucose, | |||
| Beta-hydroxybutyrate | |||
| and other non-reactive | |||
| ingredients. | Buffered aqueous | ||
| solution of D-Glucose, β- | |||
| hydroxybutyrate, | |||
| viscosity modifier, dye, | |||
| preservative and other | |||
| non-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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page 2 of 3
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 Blood | ||||||
| Glucose Test Strip | mg/dL | 25 | 97 | 260 | 347 | 444 | |
| Ketone | Precision Xceed Pro Blood | ||||||
| B-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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page 3 of 3
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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).
4
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