(35 days)
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.
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.
Here's an analysis of the provided text regarding the 'SMS Glucose Control' device, focusing on the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the 'SMS Glucose Control' does not explicitly state specific acceptance criteria (e.g., numerical thresholds for stability, precision, etc.) or detailed reported device performance values. Instead, it lists the types of performance studies conducted and concludes that these studies "support the claim of substantial equivalence" to predicate devices.
The listed performance studies are:
| Performance Characteristic | Reported Device Performance |
|---|---|
| Stability | Supported substantial equivalence |
| Open Vial | Supported substantial equivalence |
| Microbial Stress Stability | Supported substantial equivalence |
| Test precision | Supported substantial equivalence |
Note: For this type of device (quality control material), "performance" often refers to its ability to consistently produce expected glucose readings when used with the target blood glucose monitoring systems, within a specified range, and maintain that consistency over its shelf life. The document implies that the studies demonstrated this consistency and equivalence to predicate devices, but the granular data or specific acceptance ranges are not presented.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in detailed study reports accompanying the 510(k) submission, not necessarily in the summary itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable to this device. The 'SMS Glucose Control' is a quality control solution, not a diagnostic device that interprets medical images or patient data requiring expert consensus for ground truth. Its "ground truth" would be related to its manufacturing specifications (i.e., the known glucose concentration it's designed to represent) and its functional performance with specific blood glucose meters.
4. Adjudication Method
This information is not applicable as there is no diagnostic interpretation involved that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not applicable and not performed. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers) to assess the impact of AI on reader performance. The 'SMS Glucose Control' is a quality control material.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study in the context of an algorithm or AI was not applicable and not performed. The device is a physical control solution, not an algorithm. Its performance is assessed through its physical and chemical stability and its interaction with the specified blood glucose meters.
7. Type of Ground Truth Used
For a quality control material like the 'SMS Glucose Control', the "ground truth" is established by:
- Manufacturing Specifications: The known, precisely formulated glucose concentration within the control solution.
- Reference Method Assays: Verifying the actual glucose concentration of the control solution against highly accurate and traceable laboratory reference methods.
- Performance with Predicate Devices: Ensuring the control solution produces expected and consistent results within predefined ranges when tested on the specified blood glucose monitoring systems (Home Diagnostics TrackEASE Smart System® and TrueTrack Smart System® Blood Glucose Monitoring systems).
The document implies these types of internal validations were performed to ensure the control solution was fit for its intended purpose and substantially equivalent to existing controls.
8. Sample Size for the Training Set
This information is not applicable as the device is not an AI/algorithm that requires a training set. The "training" for a manufacturing process would relate to process validation and quality control, not data training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device does not involve an AI/algorithm with a training set.
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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.
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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/Aspect | PredicateDevice No. 1 | PredicateDevice No. 2 | Predicate DeviceNo. 3 | New Product |
|---|---|---|---|---|
| Name | TrueTrack SmartSystem GlucoseControl Level 0 | TrackEASESmart SystemGlucose ControlLevel 0 | Liberty GlucoseControl | Liberty GlucoseControl |
| 510(k), Date | K03070308/11/2003 | K04208008/19/2004 | K05298012/31/2005 | 1 |
| Number ofLevels | 1 | 1 | 1 | 1 |
| Analytes | Glucose | Glucose | Glucose | Glucose |
| Container | Plastic bottle withdropper-tip | Plastic bottle withdropper-tip | Plastic bottle withdropper tip | Plastic bottle withdropper 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 | PredicateDevice No. 1 | PredicateDevice No. 2 | Predicate DeviceNo. 3 | New Product |
|---|---|---|---|---|
| Matrix | Bufferedaqueous solutionof D-Glucose, aviscosityenhancing agent,preservative, dye,and other non-reactiveingredients | Bufferedaqueous solutionof D-Glucose, aviscosityenhancing agent,preservative, dye,and other non-reactiveingredients | Buffered aqueoussolution of D-Glucose, aviscosity modifier,preservatives,and other non-reactiveingredients | Identical toPredicate DeviceNo.3 |
| Indications forUse | Used to checkthe performanceof the TrueTrackSmart System. | Used to checkthe performanceof theTrackEASESmart System. | Used to check theperformance ofMedisense BloodGlucose Systemsonly. | Used to checkthe performanceof theTrackEASESmart Systemand TrueTrackSmart SystemBlood GlucoseMonitoringsystems. |
| TargetPopulation | Professional use | Professional use | Professional andhome use | Professional andhome 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.
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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 (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
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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
§ 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.