(36 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 TheraSense FreeStyle Blood Glucose System.
The SMS Glucose Control consists of a 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 provided text describes the SMS Glucose Control device, a quality control material for blood glucose monitoring systems. However, the document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices, rather than a detailed study report with specific acceptance criteria and performance data in the format requested.
Therefore, much of the requested information, particularly quantitative results, sample sizes for test/training sets, expert qualifications, and specific study designs like MRMC or standalone performance, is not available in the provided text.
Based on the available information, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria. Instead, it lists performance characteristics that were verified and concludes that the comparison of these characteristics "support the claim of substantial equivalence." This implies that the performance of the SMS Glucose Control was deemed comparable/equivalent to the predicate devices.
| Characteristic | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (as inferred from "substantial equivalence") |
|---|---|---|
| Stability | Performance equivalent to predicate devices over shelf life | Testing suggests equivalent stability |
| Open Vial | Performance equivalent to predicate devices after uncapping | Testing suggests equivalent open vial stability |
| Microbial Stress Stability | Performance equivalent to predicate devices under microbial challenge | Testing suggests equivalent microbial stress stability |
| Test Precision | Precision equivalent to predicate devices when used with the target blood glucose monitor | Testing suggests equivalent precision |
| Formulation | Identical or substantially similar to predicate devices (specifically Predicate Device No. 2 for matrix) | Identical to Predicate Device No. 2 (Buffered aqueous solution of D-Glucose, viscosity modifier, preservatives, and other non-reactive ingredients) |
| Intended Use | Same as predicate devices (for performance assessment of TheraSense FreeStyle Blood Glucose Monitor by professionals and home users) | Identical to predicate devices |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. The document only states that "Tests were performed to verify specific performance characteristics." It does not mention if the data was retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable/specified. For a quality control material like this, "ground truth" would typically refer to the known concentration of glucose in the control solution itself, which is a manufacturing specification, not something established by human experts in the context of clinical interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiology reads) where discrepancies between experts need to be resolved. This device is a chemical control solution.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a quality control solution, not an AI diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical chemical control solution, not an algorithm. Its "standalone performance" would be its chemical stability and glucose concentration accuracy. The document mentions "stability," "open vial," "microbial stress stability," and "test precision" as verified characteristics, which are indicative of standalone performance for such a device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a glucose control solution, the "ground truth" would be the assigned value of glucose concentration in the control solution itself, determined through validated analytical methods during manufacturing. The document states it contains a "known quantity of glucose," which implies this manufacturing-defined ground truth.
8. The Sample Size for the Training Set
- Not applicable. This is a manufactured chemical control solution, not a machine learning model requiring a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8.
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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 (830) 372-1391 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/Aspect | Predicate Device No. 1 | Predicate Device No. 2 | New Product |
|---|---|---|---|
| Name | TheraSense FreeStyleControl | Liberty Glucose Control | SMS Glucose Control |
| 510(k), Date | K031260, 12/19/2003 | K060481, 03/09/2006 | |
| Number ofLevels | 1 | 1 | 1 |
| Analyte | Glucose | Glucose | Glucose |
| Container | Plastic bottle withdropper-tip | Plastic bottle with droppertip | Plastic bottle withdropper tip |
| Fill Volume | 4.0 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | Red |
| Matrix | Buffered aqueoussolution of D-Glucose,viscosity modifier,preservatives, and othernon-reactive ingredients | Buffered aqueoussolution of D-Glucose, aviscosity modifier,preservatives, and othernon-reactive ingredients | Identical to PredicateDevice No. 2 |
| Indications forUse | To use with FreeStyleBlood GlucoseMonitoring System forquality control purposesto verify that theFreeStyle Meter andTest Strips are workingright. | Used to check theperformance of FreeStyleBlood Glucose Systems. | Used to check theperformance ofFreeStyle BloodGlucose Systems. |
| TargetPopulation | Professional and homeuse | Professional and homeuse | Professional andhome use |
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· ····· · ···· · ···· ··
Tests were performed to verify specific performance Performance Studies: characteristics:
-
- Stability
-
- Open Vial
-
- Microbial Stress Stability
-
- 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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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 (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.
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
Page 1 of
§ 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.