SMS GLUCOSE CONTROL, MODEL 2120061

K070649 · Spectrum Medical Supply, Inc. · JJX · Apr 12, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070649
• Device Name: SMS GLUCOSE CONTROL, MODEL 2120061
• Applicant: Spectrum Medical Supply, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 12, 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 Home Diagnostics TrackEase Smart System and the TrueTrack Smart System Blood Glucose Monitors.

Device Story

SMS Glucose Control is a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. Packaged in plastic dropper-tipped bottles, the solution includes a red dye to assist users in visually confirming application to test strips. The device is used by healthcare professionals and patients with diabetes mellitus in clinical or home settings to verify the performance of specific blood glucose monitoring systems (TrackEASE Smart System and TrueTrack Smart System). Users apply the control solution to test strips as they would a blood sample; the resulting reading is compared against expected values to ensure the monitoring system is functioning correctly. This process helps ensure the accuracy of glucose measurements, supporting reliable diabetes management.

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 repeat analysis using three lots of test strips to define acceptable ranges.

Technological Characteristics

Buffered aqueous solution containing D-Glucose, viscosity modifier, preservatives, and red dye. Non-sterile, non-hazardous, no human/animal-derived materials. Form factor: 3.6 mL plastic dropper-tipped bottle. 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 performance of Home Diagnostics TrackEase Smart System and TrueTrack Smart System Blood Glucose Monitors.

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

• TrueTrack Smart System Glucose Control Level 0 (K030703)
• TrackEASE Smart System Glucose Control Level 0 (K042080)
• Liberty Glucose Control (K052980)

Submission Summary (Full Text)

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K070649

## 5. 510(k) Summary

- 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.
- Submitter: Specialty Medical Supplies (SMS) 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: SMS Glucose Control
- Single Analyte Control Solution, All Types (Assayed Common Name: and Unassayed)
- Classification Name: Quality Control Material (assayed and unassayed).
- Classification: Class I per 21 CFR 862.1660
- Product Code: 75 JJX
- Panel: Chemistry
- Predicate Devices: Name:

Manufacturer: 510(k) No.:

Name:

TrackEASE Smart System Glucose Control Level 0 Manufacturer: Home Diagnostics, Inc. 510(k) No.: K042080

K030703

TrueTrack Smart System Glucose Control Level 0

Home Diagnostics, Inc.

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| Name: | Liberty Glucose Control |
|---------------|--------------------------------|
| Manufacturer: | Liberty Healthcare Group, Inc. |
| 510(k) No.: | K052980 |

- Device Description: The SMS Glucose Control consists of a viscosityadjusted, 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 the Home Diagnostics TrackEASE Smart System® and TrueTrack Smart System® Blood Glucose Monitoring systems.

## Comparison to Predicate Device:

| Characteristic/<br>Aspect | Predicate<br>Device No. 1 | Predicate<br>Device No. 2 | Predicate Device<br>No. 3 | New Product |
|---------------------------|------------------------------------------------------|---------------------------------------------------------|------------------------------------|------------------------------------|
| Name | TrueTrack Smart<br>System Glucose<br>Control Level 0 | TrackEASE<br>Smart System<br>Glucose Control<br>Level 0 | Liberty Glucose<br>Control | Liberty Glucose<br>Control |
| 510(k), Date | K030703<br>08/11/2003 | K042080<br>08/19/2004 | K052980<br>12/31/2005 | 1 |
| Number of<br>Levels | 1 | 1 | 1 | 1 |
| Analytes | Glucose | Glucose | Glucose | Glucose |
| Container | Plastic bottle with<br>dropper-tip | Plastic bottle with<br>dropper-tip | Plastic bottle with<br>dropper tip | Plastic bottle with<br>dropper tip |
| Fill Volume | 3 mL | 3 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | Red | Red |

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510(k) Premarket Notification: SMS Glucose Control American Biological Technologies, Inc.

| Characteristic/<br>Aspect | Predicate<br>Device No. 1 | Predicate<br>Device No. 2 | Predicate Device<br>No. 3 | New Product |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Buffered<br>aqueous solution<br>of D-Glucose, a<br>viscosity<br>enhancing agent,<br>preservative, dye,<br>and other non-<br>reactive<br>ingredients | Buffered<br>aqueous solution<br>of D-Glucose, a<br>viscosity<br>enhancing agent,<br>preservative, dye,<br>and other non-<br>reactive<br>ingredients | Buffered aqueous<br>solution of D-<br>Glucose, a<br>viscosity modifier,<br>preservatives,<br>and other non-<br>reactive<br>ingredients | Identical to<br>Predicate Device<br>No.3 |
| Indications for<br>Use | Used to check<br>the performance<br>of the TrueTrack<br>Smart System. | Used to check<br>the performance<br>of the<br>TrackEASE<br>Smart System. | Used to check the<br>performance of<br>Medisense Blood<br>Glucose Systems<br>only. | Used to check<br>the performance<br>of the<br>TrackEASE<br>Smart System<br>and TrueTrack<br>Smart System<br>Blood Glucose<br>Monitoring<br>systems. |
| Target<br>Population | Professional use | Professional use | Professional and<br>home use | Professional and<br>home 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.

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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 consists of a stylized eagle with its wings spread, and three horizontal lines representing the feathers. 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 Gormley American Biological Technologies, Inc. 940 Crossroads Blvd. Seguin, TX 78155

APR 1 2 2007

Re: k070649

Trade/Device Name: 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: March 07, 2007 Received: March 08, 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).

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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.

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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510(k) Premarket Notification: SMS Glucose Control American Biological Technologies, Inc.

Indications for Use Statement 4. 510(k) Number (if known):

Device Name: SMS 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 Home Diagnostics TrackEASE Smart System® and TrueTrack Smart System® 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)

Division Sign-Off

Office of In Vita Diagnostic Device Evaluation and Safety