RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS

K081478 · Bionostics, Inc. · JJX · Oct 6, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081478
• Device Name: RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS
• Applicant: Bionostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended 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

Device Story

RNA Medical Glucose and β-Ketone Calibration Verification Controls are 5-level, viscosity-adjusted, aqueous liquid controls; used by healthcare professionals to verify calibration and linearity of Precision Xceed Pro Blood Glucose and β-Ketone Monitoring Systems. Product packaged in plastic bottles with dropper tips for manual application to test strips. Green dye added for visual confirmation during dispensing. Controls contain D-Glucose and β-hydroxybutyrate in a buffered aqueous matrix. Healthcare professionals apply control solution to test strips; system measures analyte levels; results compared against expected values provided in package insert to ensure system accuracy across reportable range.

Clinical Evidence

No clinical data. Bench testing only. Stability established via real-time studies; shelf life 24 months at 2-30°C. Open-vial stability demonstrated <10% change in glucose and acceptable ketone value variance over 90 days.

Technological Characteristics

Aqueous solution containing glucose (0.03%-0.40%), β-hydroxybutyrate (0.01%-0.12%), viscosity enhancer, dye, buffer, and preservative. Five-level concentration set. Non-hazardous, non-biological. Standalone liquid control material.

Indications for Use

Indicated for healthcare professionals to verify calibration and linearity of glucose and β-ketone monitoring systems in clinical settings.

Regulatory Classification

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.

Predicate Devices

• RNA GL4 Glucose Calibration Verification Control (k021624)
• Precision Control Solutions (k983504)

Submission Summary (Full Text)

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K081478

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 [phone] 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<br>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<br>Calibration Verification<br>Control | Precision Control<br>Solutions | RNA Medical Glucose and<br>β-Ketone Calibration<br>Verification Controls |
| 510(k), Date: | KO21624, July 12, 2002 | K983504, July 9, 1999 | |
| Number of levels: | 5*<br>*7 vials per kit, only 5<br>levels for use on specific<br>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<br>solution of D-Glucose,<br>viscosity modifier, dye,<br>preservative and other<br>non-reactive<br>ingredients. | Buffered aqueous<br>solution of D-Glucose,<br>Beta-hydroxybutyrate<br>and other non-reactive<br>ingredients. | Buffered aqueous<br>solution of D-Glucose, β-<br>hydroxybutyrate,<br>viscosity modifier, dye,<br>preservative and other<br>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 · [phone] · Fax: [phone] .

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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<br>Glucose Test Strip | mg/dL | 25 | 97 | 260 | 347 | 444 |
| Ketone | Precision Xceed Pro Blood<br>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

- 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 [phone]. 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 [phone] or [phone] 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