(35 days)
Not Found
No
The device description and intended use clearly describe a liquid control solution for testing blood glucose monitoring systems, with no mention of AI or ML technology.
No.
This device is a glucose control solution used to assess the performance of blood glucose monitoring systems, not to treat a medical condition.
No.
This device is a control solution used to assess the performance of blood glucose monitoring systems, not to diagnose a medical condition itself.
No
The device description clearly states the product is a "viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose," which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use (i.e. for external use only)..." This is the primary indicator that the device is intended for use outside of the body to diagnose or monitor a condition.
Furthermore, the device is a "Glucose Control" solution used to "assess the performance of the Home Diagnostics TrackEASE Smart System® and TrueTrack Smart System® Blood Glucose Monitoring systems." Control solutions for blood glucose monitoring systems are a common type of IVD used to verify the accuracy and proper functioning of the testing system.
N/A
Intended Use / 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 Monitoring systems.
Product codes
75 JJX, JJX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals and in the home by people with diabetes mellitus
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Tests were performed to verify specific performance characteristics:
-
- Stability
-
- Open Vial
-
- Microbial Stress Stability
-
- Test precision
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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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 (830) 372-1391 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
TrueTrack Smart System Glucose Control Level 0
Home Diagnostics, Inc.
1
| 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/
Aspect | Predicate
Device No. 1 | Predicate
Device No. 2 | Predicate Device
No. 3 | New Product |
|---------------------------|------------------------------------------------------|---------------------------------------------------------|------------------------------------|------------------------------------|
| Name | TrueTrack Smart
System Glucose
Control Level 0 | TrackEASE
Smart System
Glucose Control
Level 0 | Liberty Glucose
Control | Liberty Glucose
Control |
| 510(k), Date | K030703
08/11/2003 | K042080
08/19/2004 | K052980
12/31/2005 | 1 |
| Number of
Levels | 1 | 1 | 1 | 1 |
| Analytes | Glucose | Glucose | Glucose | Glucose |
| Container | Plastic bottle with
dropper-tip | Plastic bottle with
dropper-tip | Plastic bottle with
dropper tip | Plastic bottle with
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/
Aspect | Predicate
Device No. 1 | Predicate
Device No. 2 | Predicate Device
No. 3 | New Product |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Buffered
aqueous solution
of D-Glucose, a
viscosity
enhancing agent,
preservative, dye,
and other non-
reactive
ingredients | Buffered
aqueous solution
of D-Glucose, a
viscosity
enhancing agent,
preservative, dye,
and other non-
reactive
ingredients | Buffered aqueous
solution of D-
Glucose, a
viscosity modifier,
preservatives,
and other non-
reactive
ingredients | Identical to
Predicate Device
No.3 |
| Indications for
Use | Used to check
the performance
of the TrueTrack
Smart System. | Used to check
the performance
of the
TrackEASE
Smart System. | Used to check the
performance of
Medisense Blood
Glucose Systems
only. | Used to check
the performance
of the
TrackEASE
Smart System
and TrueTrack
Smart System
Blood Glucose
Monitoring
systems. |
| Target
Population | Professional use | Professional use | Professional and
home use | Professional and
home use |
Performance Studies:
Tests were performed to verify specific performance characteristics:
-
- Stability
-
- Open Vial
-
- Microbial Stress Stability
-
- Test precision
Conclusion:
Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence.
3
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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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
5
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