SMS MULTI GLUCOSE CONTROL, MODEL 2120049

K070506 · Medical Specialties Supply Co., Inc. · JJX · Apr 18, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070506
• Device Name: SMS MULTI GLUCOSE CONTROL, MODEL 2120049
• Applicant: Medical Specialties Supply Co., Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Roche Accu-chek Active, the Bayer Ascensia Contour, and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.

Device Story

SMS Multi Glucose Control is an aqueous liquid solution used to verify performance of blood glucose monitors (Roche Accu-Chek Active, Bayer Ascensia Contour, LifeScan One Touch Ultra, Fast Take). Device consists of buffered D-Glucose, viscosity modifiers, preservatives, and red dye. Packaged in plastic dropper-tipped bottles for manual application to test strips. Used by patients at home or healthcare professionals in clinical settings. Red dye provides visual confirmation of application. Users compare monitor results against ranges provided in product labeling to ensure system accuracy.

Clinical Evidence

No clinical data. Bench testing only. Stability determined via real-time studies (24-month shelf-life; 90-day open-vial stability). Traceability established via in-house glucose preparation; values assigned via repeat analysis using three lots of test strips.

Technological Characteristics

Buffered aqueous solution containing D-Glucose, viscosity modifier, preservatives, and red dye. Non-sterile, non-hazardous, no human/animal-derived materials. Plastic dropper-tip bottle packaging. Storage 36 °F to 86 °F. Standard referenced: CLSI EP5-A.

Indications for Use

Indicated for healthcare professionals and people with diabetes mellitus to assess the performance of specific blood glucose monitoring systems.

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

• OneTouch Ultra Control Solution (K011479)
• Ascensia Microfill Control Solution (K023657)
• Accu-chek Active Control High Level (K011738)
• Liberty Glucose Control (K060706)

Submission Summary (Full Text)

{0}------------------------------------------------

K070506

APR 1 8 2007

#### 510(k) Summary 5.

- According to the requirements of 21 CFR 807.92, the Introduction: following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
- Specialty Medical Supplies (SMS) Submitter: 3882 NW 124th Avenue Coral Springs, FL 33065
- John C. Gormley Contact Person: American Biological Technologies, Inc. 940 Crossroads Blvd Sequin, TX 78155 [phone] ex. 210 Establishment Registration Number: 1643621
- Device Name: SMS Multi Glucose Control
- Common Name: Single Analyte Control Solution, All Types (Assayed and Unassayed)
- Quality Control Material (assayed and unassayed). Classification Name:
- Class I per 21 CFR 862.1660 Classification:
- 75 JJX Product Code:
- Panel: Chemistry
- Predicate Devices:
- Name: Manufacturer: 510(k) No.:
- Name:

Manufacturer:

510(k) No.:

Ascensia Microfill Control Solution Bayer Healthcare K023657

LifeScan, Inc.

K011479

OneTouch Ultra Control Solution

{1}------------------------------------------------

| Name: | Accu-chek Active Control High<br>Level |
|---------------|----------------------------------------|
| Manufacturer: | Roche Diagnostics Corporation |
| 510(k) No.: | K011738 |
| Name: | Liberty Glucose Control |
| Manufacturer: | Liberty Healthcare Group, Inc. |
| 510(k) No.: | K060706 |

- The SMS Multi Glucose Control consists of a Device Description: viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is nonhazardous and contains no human or animal derived materials.
- The SMS Multi Glucose Control is intended for in vitro Intended Use: diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Bayer Ascensia Contour, the Roche Accu-chek Active and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.

### Comparison to Predicate Device:

| Characteristic/<br>Aspect | Predicate<br>Device No. 1 | Predicate<br>Device No. 2 | Predicate<br>Device No. 3 | Predicate<br>Device No. 4 | New<br>Product |
|---------------------------|----------------------------------------|----------------------------------------------|----------------------------------------------|---------------------------------------|---------------------------------------|
| Name | OneTouch<br>Ultra Control<br>Solution | Ascensia<br>Microfill<br>Control<br>Solution | Accu-chek<br>Active<br>Control High<br>Level | Liberty<br>Glucose<br>Control | SMS Multi<br>Glucose<br>Control |
| 510(k), Date | K011479,<br>06/02/2000 | K023657<br>05/12/2003 | K011738<br>06/20/2001 | K060706<br>04/28/2006 | |
| Number of<br>Levels | 1 | 1 | 2 | 1 | 1 |
| Analytes | Glucose | Glucose | Glucose | Glucose | Glucose |
| Container | Plastic bottle<br>with dropper-<br>tip | Plastic bottle<br>with dropper-<br>tip | Plastic bottle<br>with dropper-<br>tip | Plastic bottle<br>with dropper<br>tip | Plastic bottle<br>with dropper<br>tip |
| Fill Volume | 3 mL | 2.5 mL | 4 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | N/A | Red | Red |

{2}------------------------------------------------

| Characteristic/<br>Aspect | Predicate<br>Device No. 1 | Predicate<br>Device No. 2 | Predicate<br>Device No. 3 | Predicate<br>Device No. 4 | New<br>Product |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Buffered<br>aqueous<br>solution of D-<br>Glucose,<br>viscosity<br>modifier,<br>preservatives,<br>and other<br>non-reactive<br>ingredients | Buffered<br>aqueous<br>solution of D-<br>Glucose,<br>viscosity<br>modifier,<br>preservatives,<br>and other non-<br>reactive<br>ingredients | Buffered<br>solution<br>containing<br>Glucose,<br>preservative<br>and a<br>thickening<br>agent. | Buffered<br>aqueous<br>solution of D-<br>Glucose, a<br>viscosity<br>modifier,<br>preservatives<br>and other<br>non-reactive<br>ingredients | Identical to<br>Predicate<br>Device No.<br>4. |
| Indications for<br>Use | Used with<br>OneTouch<br>Ultra Brand<br>Systems, The<br>OneTouch<br>FastTake<br>System,<br>InDuo Brand<br>Systems and<br>OneTouch<br>UltraSmart<br>Systems to<br>check that<br>the meter and<br>test strips are<br>working<br>together as a<br>system and<br>that the user<br>is performing<br>the test<br>correctly | For use with<br>the Ascensia<br>Contour Blood<br>Glucose Meter<br>and the<br>Ascensia<br>MICROFILL<br>Test Strips as<br>a quality<br>control check. | Used to<br>perform<br>quality<br>control<br>checks to<br>ensure that<br>the Accu-<br>chek Active<br>System is<br>working<br>properly and<br>that the blood<br>glucose<br>results are<br>reliable. | Used to<br>check the<br>performance<br>of OneTouch<br>Ultra,<br>OneTouch<br>FastTake,<br>Accu-chek<br>Active, and<br>Ascensia<br>Contour<br>Blood<br>Glucose<br>Systems. | Used to<br>check the<br>performance<br>of<br>OneTouch<br>Ultra,<br>OneTouch<br>FastTake,<br>Accu-chek<br>Active, and<br>Ascensia<br>Contour<br>Blood<br>Glucose<br>Systems. |
| Target<br>Population | Professional<br>and home<br>use | Professional<br>and home use | Professional<br>and home<br>use | Professional<br>and home<br>use | Professional<br>and home<br>use |

# Performance Studies:

### Tests were performed to verify specific performance characteristics:

- 1. Stability
- 2. Open Vial
- 3. Microbial Stress Stability
- 4. Test precision

## Conclusion:

Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence.

{3}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Speciality Medical Supplies c/o Mr. John Gormley American Biological Technologies, Inc. 940 Crossroads Blyd. Seguin. TX 78155

APR 1 8 2007

Re: k070506

> Trade/Device Name: SMS Multi Glucose Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material assayed and unassaved Regulatory Class: Class I, reserved Product Code: JJX Dated: February 21, 2007 Received: February 21, 2007

Dear Mr. Gormley:

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}------------------------------------------------

Page 2 -

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 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 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 toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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

{5}------------------------------------------------

#### 4. Indications for Use Statement

510(k) Number (if known): K070500

Device Name: SMS Multi Glucose Control.

Indications For Use:

For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Roche Accu-chek Active, the Bayer Ascensia Contour, and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benam
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K070506