GLUCOSE CONTROL SOLUTION FOR BD LATITUDE

K021697 · Bionostics, Inc. · JJX · Jul 12, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021697
• Device Name: GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
• Applicant: Bionostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jul 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Glucose Control Solution for BD Latitude™ Blood Glucose Monitoring System is intended for use to verify the performance of the BD Latitude™ BGM System at glucose levels within the reportable range. The Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.

Device Story

Glucose Control Solution for BD Latitude™ is a three-level, viscosity-adjusted, aqueous liquid control solution used for periodic quality control (QC) checks of the BD Latitude™ Blood Glucose Monitoring (BGM) system. The solution is packaged in plastic bottles with dropper tips for manual application onto test strips. The blue-colored solution simulates the response of whole blood on the BGM system. It is used by healthcare professionals in clinical settings and by patients with diabetes at home to verify that the BGM system is operating within its reportable range. By confirming the accuracy of the BGM system, the device helps ensure reliable glucose monitoring, which supports clinical decision-making regarding diabetes management.

Clinical Evidence

No clinical data. Bench testing only, including closed bottle stability, stability after opening, correlation to gravimetric D-glucose, and test precision and range.

Technological Characteristics

Viscosity-adjusted, aqueous glucose control solution. Contains D-glucose, viscosity modifiers, and preservatives. Three-level concentration. Blue colorant. Non-hazardous, non-biological. Manual application via dropper tip. Standalone quality control material.

Indications for Use

Indicated for use by healthcare professionals and individuals with diabetes mellitus to verify the performance of the BD Latitude™ Blood Glucose Monitoring System at glucose levels within the reportable range.

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

• Multi-Meter Glucose Calibration Verification Material (K012430)

Submission Summary (Full Text)

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## JUL 12 2002

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# 510(k) Summary*

- Submitter's name, address (a) (1) Bionostics, Inc. 7 Jackson Road Devens, MA 01432
Contact Person Kathleen Storro Director, QA & Regulatory Affairs [phone] x 220

### Date of preparation of this summary: 17 May 2002

| (2) Device trade or proprietary name: | Glucose Control Solution for<br>BD Latitude™ Blood Glucose System |
|---------------------------------------|-------------------------------------------------------------------|
|---------------------------------------|-------------------------------------------------------------------|

### Device common or usual name or classification name:

Multi Analyte Control Solution, All Types (Assayed and Unassayed)

| CLASSIFICATION | | | |
|---------------------------------|------------------|-------|-----------|
| PRODUCT NOMENCLATURE | NUMBER | CLASS | PANEL |
| SINGLE ANALYTE CONTROL SOLUTION | 862.1660 .75 JJX | I | CHEMISTRY |

#### Substantial Equivalence (3)

Glucose Control Solution for BD Latitude™ is substantially equivalent in function, safety and efficacy to currently marketed devices produced by Bionostics. In example:

Comparison of Glucose Control Solution for BD Latitude™ to predicate devices for substantial equivalency

| Characteristic | Predicate Device | Modified Device |
|-------------------|----------------------------------------------------------|---------------------------------------------|
| Name: | Multi-Meter Glucose Calibration<br>Verification Material | Glucose Control Solution for BD<br>Latitude |
| 510(k), Date: | K012430, 08/27/01 | |
| Number of levels: | 5 | 3 |
| Analytes: | Glucose | Glucose |
| Container: | plastic bottle | plastic bottle |
| Fill volume: | 4 mL | 4 mL |
| Color: | red | blue |
| Matrix: | Buffered, aqueous solution of D- | Buffered, aqueous solution of D- |
| | Glucose, viscosity modifier, | Glucose, viscosity modifier, |
| | preservatives and other, non- | preservatives and other, non-reactive |
| | reactive ingredients. | ingredients. |

· Devens, MA USA 01432 · · [phone] · Fax: [phone] Jackson Road

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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#### (4) Description of the new device

Glucose Control Solution for BD Latitude™ is a three-level, viscosityadjusted, aqueous liquid glucose control solution. Glucose Control Solution for BD Latitude™ 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 blue color to help users see the solution while dispensing onto a test strip.

Glucose Control Solution for BD Latitude™ contains glucose values at three points within the reportable range and verifies performance of the BD Latitude ™ BGM.

Glucose Control Solution for BD Latitude™ is a non-hazardous aqueous solution containing no biological materials.

#### (5) Intended use of the device

Glucose Control Solution for BD Latitude™ is intended to be used to monitor and evaluate the analytical performance of the BD Latitude™ BGM.

#### Technological characteristics of the device. (6)

This material consists of viscosity-adjusted, aqueous glucose control solutions prepared in three specific glucose concentrations. The solutions have been optimized to simulate the response of whole blood on the BD Latitude™ BGM system.

### (b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.

Tests were conducted to verify specific performance requirements:

- a) Closed bottle stability
- b) Stability after opening
- c) Correlation to gravimetric D-glucose
- d) Test precision and range

### Summary of clinical tests submitted with the premarket notification for the (b) (2) device.

N/A

#### (b) (3) Conclusions drawn from the clinical and non-clinical trials.

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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

JUL 12 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850 .

Ms. Kathleen Storro Director, QA and Regulatory Affairs Bionostics 7 Jackson Road Devens, MA 01432

k021697 Re:

Trade/Device Name: Glucose Control Solution for BD Latitude™ Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: May 17, 2002 Received: May 22, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/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:

### Glucose Control Solution for BD Latitude™ Device Name:

## Indications for Use:

Glucose Control Solution for BD Latitude™ Blood Glucose Monitoring System is intended for use to verify the performance of the BD Latitude™ BGM System at glucose levels within the reportable range. The Glucose Control Solution is intended for use by healthcare professionals and people with diabetes mellitus at home.

For In Vitro Diagnostic Use

Scan Coper

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number K021697

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

(Optional Format 1-2-96)

510(K) BD LATITUDE