(16 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 Bayer Ascensia DEX 2/DEX and BREEZE Blood Glucose Monitors.
The Liberty Glucose Normal Control Solution 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 510(k) Premarket Notification for the "Liberty Glucose Normal Control Solution."
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not explicitly state numerical acceptance criteria with corresponding reported device performance values in a clear table format for the Liberty Glucose Normal Control Solution itself. Instead, it refers to performance characteristics that were verified.
The performance studies mentioned were conducted to verify:
- Stability (Accelerated and Real-time)
- Open Vial
- Microbial Stress Stability
- Test precision
The conclusion stated: "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence," implying that the device met the internal criteria for these characteristics,
but the specific numerical targets or results are not detailed.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify sample sizes for any of the tests performed (Stability, Open Vial, Microbial Stress Stability, Test Precision).
The data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. As this is a control solution for glucose meters, the "ground truth" would likely be based on established analytical methods for glucose concentration, not expert interpretation.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of a control solution, adjudication methods common in diagnostic imaging or clinical trials involving subjective interpretation would not typically apply.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging AI) and explicitly measures human reader performance with and without AI assistance. This device is a control solution for glucose meters.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device itself is a standalone control solution (used to verify a glucose meter's performance), the document does not describe a "standalone algorithm-only performance" study in the context of an AI/algorithm. The performance studies listed (Stability, Open Vial, Microbial Stress Stability, Test Precision) refer to the chemical and physical properties of the control solution.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For a glucose control solution, the 'ground truth' for its performance characteristics (stability, precision) would be established by:
- Analytical Chemistry Methods: The known quantity of glucose in the solution would be precisely measured using a highly accurate reference method.
- Stability Testing Protocols: Standard protocols for assessing the degradation or change in concentration over time under various conditions.
- Precision Testing Protocols: Repeated measurements to determine the reproducibility of the glucose concentration.
The document does not explicitly state the specific methods used to establish these ground truths, but it implies standard laboratory practices for quality control materials.
8. The Sample Size for the Training Set
This information is not applicable or provided. The device is a physical control solution, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided, as there is no training set for this type of device.
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510(k) Premarket Notification: Liberty Glucose Normal Control Solution American Biological Technologies, Inc.
2006 MAR Y
-
- 510(k) Summary
| Introduction: | According to the requirements of 21 CFR 807.92, thefollowing information provides sufficient detail tounderstand the basis for a determination ofsubstantial equivalence. | ||
|---|---|---|---|
| Submitter: | Liberty Healthcare Group, Inc.8883 Liberty LanePort St. Luce, FL 34952 | ||
| Contact Person: | John C. GormleyAmerican Biological Technologies, Inc.940 Crossroads BlvdSeguin, TX 78155(830) 372-1391 ex. 210Establishment Registration Number: 1643621 | ||
| Device Name: | Liberty Glucose Normal Control Solution | ||
| Common Name: | Single Analyte Control Solution, All Types (Assayedand 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: | Bayer Ascensia AUTODISC NormalControl | |
| Manufacturer: | Bayer Healthcare, LLC. | ||
| 510(k) No.: | K963500 |
Page 12 of 43
Name:
Manufacturer:
510(k) No.:
Liberty Glucose Control
Liberty Healthcare Group
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510(k) Premarket Notification: Liberty Glucose Normal Control Solution American Biological Technologies, Inc.
- Device Description: The Liberty Glucose Normal Control Solution 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.
- Intended Use: The Liberty Glucose Normal Control Solution 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 Bayer Ascensia DEX 2/DEX and BREEZE Blood Glucose Monitors.
Comparison to Predicate Device:
| Characteristic/Aspect | Predicate Device No. 1 | Predicate Device No. 2 | New Product |
|---|---|---|---|
| Name | Ascensia AUTODISC NormalControl | Liberty Glucose Control | Liberty GlucoseNormal ControlSolution |
| 510(k), Date | K963500, 01/21/1997 | K052980 11/30/2005 | |
| Number ofLevels | 1 | 1 | 1 |
| Analyte | Glucose | Glucose | Glucose |
| Container | Plastic bottle with dropper-tip | Plastic bottle withdropper-tip | Plastic bottle withdropper-tip |
| Fill Volume | 2.5 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | Red |
| Matrix | Red solution containing ameasured amount ofglucose. | Buffered aqueoussolution of D-Glucose,viscosity modifiers,preservatives, and othernon-reactive ingredients | Buffered aqueoussolution of D-Glucose,viscosity modifiers,preservatives, andother non-reactiveingredients |
| Indications forUse | For use with an appropriateAscensia/Glucometer BloodGlucose Meter andAscensia AUTODISC TestStrip Disc as a qualitycontrol check to verify theaccuracy of blood glucosetest results. | Used to check theperformance ofMedisense BloodGlucose Systems only. | To check theperformance of theBayer Ascensia DEX2/DEX and BREEZEBlood GlucoseMonitors. |
| TargetPopulation | Professional and home use | Professional and homeuse | Professional andhome use |
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510(k) Premarket Notification: Liberty Glucose Normal Control Solution American Biological Technologies, Inc.
Performance Studies: Tests were performed to verify specific performance characteristics:
-
- Stability (Accelerated and Real-time)
-
- 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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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.
Public Health Service
Food and Drug Administrati 2098 Gaither Road Rockville MD 20850
Liberty Healthcare Group, Inc. c/o Mr. John Gromley Vice President, Quality Assurance /Regulatory Affairs American Biological Technologies, Inc. 940 Crossroads Blvd. Seguin, Texas 78155
Re: K060426
Trade/Device Name: Liberty Glucose Normal Control Solution Regulation Number: 21 CFR§862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: February 21, 2006 Received: February 21, 2006
Dear Mr. Gromley:
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).
DEPARTMENT OF HEALTH & HUMAN
2006 MAR 9
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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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutt
Alberto Gutierrez, Ph.D. 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 (if known): K060426
Device Name: Liberty Glucose Normal Control Solution
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 Bayer Ascensia DEX 2/DEX and BREEZE Blood Glucose Monitors.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 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)
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of _1
510(k) K060426
§ 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.