(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 Liberty Blood Glucose Monitoring System.
The Liberty Control Solutions consist of a viscosity-adjusted, aqueous liquid control solution containing known quantities of glucose. They are 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 information regarding the Liberty Control Solutions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific acceptance criteria (e.g., numerical thresholds for stability or precision). It lists the types of performance studies conducted but does not detail the pass/fail criteria used. Similarly, it does not provide detailed reported device performance in terms of specific values (e.g., actual stability ranges, precision CV%).
However, based on the general information, we can infer that the acceptance criteria would be linked to demonstrating substantial equivalence to the predicate devices. This implies that the performance (stability, precision) of the Liberty Control Solutions should be comparable to or better than that of the predicate devices.
| Acceptance Criterion (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Stability (Shelf-life) is acceptable. | Tests were performed to verify stability. |
| Open Vial Stability is acceptable. | Tests were performed to verify open vial stability. |
| Microbial Stress Stability is acceptable. | Tests were performed to verify microbial stress stability. |
| Test precision is acceptable. | Tests were performed to verify test precision. |
| Performance characteristics (formulation, intended use) support substantial equivalence to predicate devices. | Comparison of the performance characteristics, formulation, and intended use support the claim of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the performance studies (stability, open vial stability, microbial stress stability, test precision).
The document does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of data collection).
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable to this device. The Liberty Control Solutions are quality control materials, and their performance is assessed against established analytical methods and specifications, not against expert interpretation of biological samples or images. Therefore, there is no "ground truth" in the sense of expert consensus on patient diagnoses or pathology for this type of device.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which are not relevant to the evaluation of a quality control solution.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) to assess the impact of AI assistance on reader performance. The Liberty Control Solutions are quality control materials for blood glucose monitoring systems and do not involve human readers in this context.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done in the context of an AI algorithm. The device is a chemical control solution, not an AI algorithm. Its performance is inherent to its chemical composition and manufacturing, assessed through laboratory tests.
7. The Type of Ground Truth Used
For quality control materials like the Liberty Control Solutions, the "ground truth" for performance studies would be:
- Reference Method/Standard Measurements: For glucose concentration, the accurate measurement of glucose using a highly precise and validated reference method (e.g., hexokinase-based methods) would serve as the ground truth.
- Established Specifications: Manufacturers define specifications for stability (e.g., acceptable percentage change over time) and precision (e.g., maximum coefficient of variation). The "ground truth" for these tests is whether the measured performance falls within these predefined acceptable ranges.
The document does not explicitly detail the specific reference methods or internal specifications used to establish ground truth for each performance study.
8. The Sample Size for the Training Set
This information is not applicable. The Liberty Control Solutions are chemical control solutions, not machine learning algorithms or AI models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
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FEB - I 2007
510(k) Premarket Notification: Liberty Control Solutions American Biological Technologies, Inc.
- ડ. 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: Liberty Healthcare Group, Inc. 8883 Liberty Lane Port St. Luce, FL 34952
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: Liberty Control Solutions (Normal Level and High Level)
Common Name: Single Analyte Control Solution, All Types (Assayed and Unassayed)
Classification Name: Quality Control Material (assayed and unassayed).
Classification: Class I per 21 CFR 862.1660
Name:
Product Code: 75 JJX
Panel: Chemistry
Predicate Devices:
Manufacturer: 510(k) No.:
AqaMatrix Liberty Control Solutions (Normal level and High level) AgaMatrix, Inc. K052762
Name: Liberty Glucose Control Manufacturer: Liberty Healthcare Group, Inc. 510(k) No .: K052980
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510(k) Premarket Notification: Liberty Control Solutions American Biological Technologies, Inc.
- The Liberty Control Solutions consist of a viscosity-Device Description: adjusted, aqueous liquid control solution containing known quantities of glucose. They are 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 Liberty Control Solutions are intended for in vitro Intended Use: diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Liberty Blood Glucose Monitoring System.
Comparison to Predicate Device:
| Characteristic/Aspect | Predicate Device No.1 | Predicate DeviceNo. 2 | New Product |
|---|---|---|---|
| Name | AgaMatrix LibertyControl Solutions(Normal and HighLevels) | Liberty GlucoseControl | Liberty ControlSolutions (Normaland High Levels) |
| 510(k), DateNumber of Levels | K052762, 01/23/20062 | K052980,11/30/20051 | 2 |
| Analytes | Glucose | Glucose | Glucose |
| Container | Plastic bottle withdropper-tip | Plastic bottle withdropper tip | Plastic bottle withdropper tip |
| Fill Volume | 6 mL | 3.6 mL | 3.6 mL |
| Color | Blue | Red | Red |
| Matrix | Buffered aqueoussolution of D-Glucose,viscosity modifier,preservatives, andother non-reactiveingredients | Buffered aqueoussolution of D-Glucose, viscositymodifiers.preservatives, andother non-reactiveingredients | Buffered aqueoussolutions of D-Glucose, viscositymodifiers,preservatives, andother non-reactiveingredients |
| Indications for Use | Used with the LibertyMeter and Test Stripsas a quality controlcheck to verify theaccuracy of bloodglucose test results. | Used to check theperformance ofMedisense BloodGlucose Systemsonly. | Used to check theperformance ofLiberty BloodGlucose MonitoringSystem. |
| Target Population | Professional andhome use | Professional andhome use | Professional andhome use |
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510(k) Premarket Notification: Liberty Control Solutions American Biological Technologies, Inc.
Performance Studies: Tests were performed to verify specific performance characteristics:
-
- Stability
-
- Open Vial Stability
-
- 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 below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Liberty Healthcare Group, Inc. FEB - 1 2007 John C Gormley c/o Americal Biological Technologies, Inc. 940 Crossroads Blvd. Seguin, TX 78155
Re: K063855
Trade Name: Liberty Control Solutions (Normal Level and High Level) Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I Product Code: JJX Dated: December 27, 2006 Received: December 28, 2006
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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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 tolla the north ne (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean m. Cooper, M.S., D.v.M.
Yéan 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: Liberty Control Solutions American Biological Technologies, Inc.
Indications for Use Statement বঁ
510(k) Number (if known): K063655
Device Name: Liberty Control Solutions (Normal Level and High Level)
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 Liberty Blood Glucose Monitoring System ..
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
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Division Sign-Off
Office of In Vitro Dlagnostic
§ 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.