(35 days)
Not Found
No
The device description and performance studies focus on the chemical composition and stability of a control solution, with no mention of AI or ML.
No
The document states the device is for "in vitro diagnostic use" to assess the performance of a blood glucose monitoring system, not for treating a condition.
No
The device is a control solution used to assess the performance of a blood glucose monitoring system, not to diagnose a medical condition itself.
No
The device description explicitly states the product is a "viscosity-adjusted, aqueous liquid control solution containing known quantities of glucose," packaged in "plastic dropper tipped bottles." This describes a physical, liquid-based product, 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 defining characteristic of an IVD.
The device description further supports this by describing a "control solution" used to "assess the performance of the Liberty Blood Glucose Monitoring System," which is a common application for IVD control materials.
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 Liberty Blood Glucose Monitoring System ..
Product codes
75 JJX, JJX
Device Description
- 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were performed to verify specific performance characteristics:
- Stability
- Open Vial Stability
- Microbial Stress Stability
- Test precision
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
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
1
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 Device
No. 2 | New Product |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Name | AgaMatrix Liberty
Control Solutions
(Normal and High
Levels) | Liberty Glucose
Control | Liberty Control
Solutions (Normal
and High Levels) |
| 510(k), Date
Number of Levels | K052762, 01/23/2006
2 | K052980,11/30/2005
1 | 2 |
| Analytes | Glucose | Glucose | Glucose |
| Container | Plastic bottle with
dropper-tip | Plastic bottle with
dropper tip | Plastic bottle with
dropper tip |
| Fill Volume | 6 mL | 3.6 mL | 3.6 mL |
| Color | Blue | Red | Red |
| Matrix | Buffered aqueous
solution of D-Glucose,
viscosity modifier,
preservatives, and
other non-reactive
ingredients | Buffered aqueous
solution of D-
Glucose, viscosity
modifiers.
preservatives, and
other non-reactive
ingredients | Buffered aqueous
solutions of D-
Glucose, viscosity
modifiers,
preservatives, and
other non-reactive
ingredients |
| Indications for Use | Used with the Liberty
Meter and Test Strips
as a quality control
check to verify the
accuracy of blood
glucose test results. | Used to check the
performance of
Medisense Blood
Glucose Systems
only. | Used to check the
performance of
Liberty Blood
Glucose Monitoring
System. |
| Target Population | Professional and
home use | Professional and
home use | Professional and
home use |
2
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.
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 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).
4
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
5
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)
$\lim_{x \to \infty} \frac{x^2}{e^x} = 0$
Division Sign-Off
Office of In Vitro Dlagnostic