SMS GLUCOSE CONTROL, MODEL 2120059

K071433 · Specialty Medical Supplies · JJY · Jun 28, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071433
• Device Name: SMS GLUCOSE CONTROL, MODEL 2120059
• Applicant: Specialty Medical Supplies
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The SMS Glucose Control is intended 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 TheraSense FreeStyle Blood Glucose Monitor.

Device Story

SMS Glucose Control is an aqueous, viscosity-adjusted liquid solution containing a known quantity of glucose. Packaged in plastic dropper-tipped bottles, it includes a red dye to assist users in confirming application to test strips. Used by healthcare professionals and patients with diabetes in clinical or home settings to verify the performance of the TheraSense FreeStyle Blood Glucose Monitoring System. The user applies the control solution to a test strip; the meter reads the result, which is then compared against the expected range provided by the manufacturer. This process ensures the meter and test strips are functioning correctly, providing confidence in subsequent patient blood glucose readings.

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 using three lots of test strips with 10 replicates per lot.

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-tipped bottle. Standard: CLSI EP5-A for precision evaluation.

Indications for Use

Indicated for healthcare professionals and home users with diabetes mellitus to verify the performance of the TheraSense FreeStyle Blood Glucose Monitoring System.

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

• TheraSense FreeStyle Control (k031260)
• Liberty Glucose Control (k060481)

Submission Summary (Full Text)

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K071433

## 5. 510(k) Summary

JUN 28 2007

- Introduction: According to the requirements of 21 CFR 807.92, the 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
- Contact Person: John C. Gormley American Biological Technologies, Inc. 940 Crossroads Blvd Seguin, TX 78155 [phone] ex. 210 Establishment Registration Number: 1643621

Device Name:

Common Name:

Classification Name: Quality Control Material (assayed and unassayed).

SMS Glucose Control

and Unassayed)

Class I per 21 CFR 862.1660 Classification:

Name:

Manufacturer:

510(k) No.:

Product Code: 75 JJX

Chemistry

Predicate Devices:

Panel:

TheraSense FreeStyle Control TheraSense, Inc. K031260

Name: Liberty Glucose Control Manufacturer: Liberty Healthcare Group, Inc. 510(k) No.: K060481

Single Analyte Control Solution, All Types (Assayed

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The SMS Glucose Control consists of a viscosity-Device Description: 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 Glucose Control is intended for in vitro Intended Use: 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 TheraSense FreeStyle Blood Glucose Monitor.
## Comparison to Predicate Device:

| Characteristic/<br>Aspect | Predicate Device No. 1 | Predicate Device No. 2 | New Product |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Name | TheraSense FreeStyle<br>Control | Liberty Glucose Control | SMS Glucose Control |
| 510(k), Date | K031260, 12/19/2003 | K060481, 03/09/2006 | |
| Number of<br>Levels | 1 | 1 | 1 |
| Analyte | Glucose | Glucose | Glucose |
| Container | Plastic bottle with<br>dropper-tip | Plastic bottle with dropper<br>tip | Plastic bottle with<br>dropper tip |
| Fill Volume | 4.0 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | Red |
| Matrix | Buffered aqueous<br>solution of D-Glucose,<br>viscosity modifier,<br>preservatives, and other<br>non-reactive ingredients | Buffered aqueous<br>solution of D-Glucose, a<br>viscosity modifier,<br>preservatives, and other<br>non-reactive ingredients | Identical to Predicate<br>Device No. 2 |
| Indications for<br>Use | To use with FreeStyle<br>Blood Glucose<br>Monitoring System for<br>quality control purposes<br>to verify that the<br>FreeStyle Meter and<br>Test Strips are working<br>right. | Used to check the<br>performance of FreeStyle<br>Blood Glucose Systems. | Used to check the<br>performance of<br>FreeStyle Blood<br>Glucose Systems. |
| Target<br>Population | Professional and home<br>use | Professional and home<br>use | Professional and<br>home use |

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

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

Comparison of the performance characteristics, Conclusion: formulation and intended use 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 & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Specialty Medical Supplies c/o Mr. John C. Gormley American Biological Technologies, Inc. 940 Crossroads Blvd. Seguin, TX 78155

JUN 2 8 2007

Re: k071433

Trade/Device Name: Specialty Medical Supplies (SMS) Glucose Control Regulation Number: 21 CFR§862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Code: JJX Dated: May 22, 2007 Received: May 23, 2007

Dear Mr. Gormley:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nove rollowed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surver in May 28, 1976, the enactment date of the Medical Device Amendments, or to connineroo pror to May 2011 - 11:14 provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Coometer For (110) was the device, subject to the general controls provisions of the Act. The I ou may, aron's 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 1 loase of actious that I Drivinsion that your device complies with other requirements of the Act that I Drinatal statutes and regulations administered by other Federal agencies. You must or any I ocoral station and 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 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 yours.

Jean M. Cooper, M.S., D.V.M.

Jean 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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## Indications for Use

510(k) Number: 长 071433

SMS Glucose Control Device Name:

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 TheraSense FreeStyle Blood Glucose System.

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)

C

Division Sign-Off

510(k)

Office of In Vitro Diagnostic Device Evaluation and Safety

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