(43 days)
No
The device description and performance studies focus on the chemical and physical properties of a control solution, with no mention of AI or ML.
No.
This device is an in vitro diagnostic control solution used to assess the performance of blood glucose monitors, not to treat a medical condition.
No
Explanation: The device is described as a "Normal Glucose Control" solution, used to assess the performance of blood glucose monitors, not to diagnose a condition in a patient. While it is for "in vitro diagnostic use," this refers to its role in checking the accuracy of diagnostic devices.
No
The device description clearly states it is a liquid control solution packaged in bottles, indicating it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use".
- Function: The device is a control solution used to assess the performance of blood glucose monitors, which are themselves IVD devices used to measure glucose in a biological sample (blood) outside of the body. Control solutions are essential for ensuring the accuracy and reliability of these diagnostic tests.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Bayer Ascensia Microfill, the Roche Accu-chek Active and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.
Product codes
75 JJX
Device Description
The Liberty Normal 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 non-hazardous 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
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.
- Test precision
Key Metrics
Not Found
Predicate Device(s)
K001427, K023657, K011738, K052980
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
Ka60706
5. 510(k) Summary
.
O
.
| 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. |
|---|---|
| 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 Normal Glucose Control |
| 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 |
| Product Code: | 75 JJX |
| Panel: | Chemistry |
| Predicate Devices: |
| Name: | OneTouch Ultra Control Solution |
|---|---|
| Manufacturer: | LifeScan, Inc. |
| 510(k) No.: | K001427 |
| Name: | Ascensia Microfill Control Solution |
|---|---|
| Manufacturer: | Bayer Healthcare |
| 510(k) No.: | K023657 |
1
| Name: | Accu-chek Active Control High Level |
|---|---|
| Manufacturer: | |
| 510(k) No.: | Roche Diagnostics Corporation |
| K011738 | |
| Name: | |
| Manufacturer: | |
| 510(k) No.: | Liberty Glucose Control |
| Liberty Healthcare Group, Inc. | |
| K052980 | |
| Device Description: | The Liberty Normal 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 non-hazardous and contains no human or animal derived |
- The Liberty Normal Glucose Control is intended for in Intended Use: vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Bayer Ascensia Microfill, the Roche Accu-chek Active and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.
materials.
Comparison to Predicate Device:
| Characteristic/
Aspect | Predicate
Device No. 1 | Predicate
Device No. 2 | Predicate
Device No. 3 | Predicate
Device No. 3 | New
Product |
|---------------------------|----------------------------------------|----------------------------------------------|----------------------------------------------|---------------------------------------|-----------------------------------------|
| Name | OneTouch
Ultra Control
Solution | Ascensia
Microfill
Control
Solution | Accu-chek
Active
Control High
Level | Liberty
Glucose
Control | Liberty
Normal
Glucose
Control |
| 510(k), Date | K001427,
06/02/2000 | K02367
05/12/2003 | K011738
06/20/2001 | K052980
11/30/2005 | |
| Number of
Levels | 1 | 1 | 2 | 1 | 1 |
| Analytes | Glucose | Glucose | Glucose | Glucose | Glucose |
| Container | Plastic bottle
with dropper-
tip | Plastic bottle
with dropper-
tip | Plastic bottle
with dropper-
tip | Plastic bottle
with dropper
tip | Plastic bottle
with dropper
tip |
| Fill Volume | 3 mL | 2.5 mL | 4 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | N/A | Red | Red |
2
510(k) Premarket Notification: Liberty Normal Glucose Control American Biological Technologies, Inc.
| Characteristic/
Aspect | Predicate
Device No. 1 | Predicate
Device No. 2 | Predicate
Device No. 3 | Predicate
Device No. 3 | New
Product |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Buffered
aqueous
solution of D-
Glucose,
viscosity
modifier,
preservatives,
and other
non-reactive
ingredients | Buffered
aqueous
solution of D-
Glucose,
viscosity
modifier,
preservatives,
and other non-
reactive
ingredients | Buffered
aqueous
solution
containing
Glucose,
preservative
and a
thickening
agent. | Buffered
aqueous
solution of D-
Glucose,
viscosity
modifiers,
preservatives
, and other
non-reactive
ingredients | Buffered
aqueous
solution of
D-Glucose,
viscosity
modifiers,
preservative
s, and other
non-reactive
ingredients |
| Indications for
Use | Used with
OneTouch
Ultra Brand
Systems, The
OneTouch
FastTake
System,
InDuo Brand
Systems and
OneTouch
UltraSmart
Systems to
check that
the meter and
test strips are
working
together as a
system and
that the user
is performing
the test
correctly | For use with
the Ascensia
Contour Blood
Glucose Meter
and the
Ascensia
MICROFILL
Test Strips as
a quality
control check. | Used to
perform
quality
control
checks to
ensure that
the Accu-
chek Active
System is
working
properly and
that the blood
glucose
results are
reliable. | Used to
check the
performance
of Medisense
Blood
Glucose
Systems
only. | Used to
check the
performance
of
OneTouch
Ultra,
OneTouch
FastTake,
Accu-chek
Active, and
Ascensia
Microfill
Blood
Glucose
Systems. |
| Target
Population | Professional
and home
use | Professional
and home use | Professional
and home
use | Professional
and home
use | Professional
and home
use |
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.
3
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Liberty Healthcare Group, Inc. c/o Mr. John Gormley Vice President Quality Assurance/Regulatory Affairs American Biological Technologies, Inc. 940 Crossroads Blvd. Seguin, TX 78155
APR 2 8 2006
Re: K060706 Trade/Device Name: Liberty Normal Glucose Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: March 14, 2006 Received: March 23, 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).
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) 276-0484. 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 Gutz
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
5
র্বা Indications for Use Statement
510(k) Number (if known):
Device Name: Liberty Normal 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 Roche Accu-chek Active, the Bayer Ascensia Microfill, and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
AND/OR
C.A.C
C:
Date
51006 K060706
safety