(109 days)
Not Found
No
The description focuses on a standard electrochemical glucose measurement principle and does not mention any AI/ML components or algorithms.
No
The device is an in vitro diagnostic (IVD) tool used for monitoring blood glucose levels, not for directly treating or preventing a disease.
Yes
The device is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management, which is a diagnostic purpose.
No
The device description clearly states it is an "in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the FREEDOM Test Strips." It also describes a "Meter" that measures an electrical current from the test strip. This indicates the device includes hardware components (the meter and test strips) in addition to any potential software.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The FREEDOM Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only)."
- Device Description: The "Device Description" section also explicitly states: "The FREEDOM Blood Glucose Monitoring System is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood..."
- Test Principle: The description of the test principle further reinforces this by explaining that the device measures glucose concentration in human blood using a chemical reaction on a test strip, which is a characteristic of in vitro diagnostics.
Therefore, the text definitively identifies the FREEDOM Blood Glucose Monitoring System as an IVD.
N/A
Intended Use / Indications for Use
The FREEDOM Blood Glucose Monitoring System, is used for the quantitative measurement of glucose in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The FREEDOM Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing site include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh and calf.
The FREDOM Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The FREEDOM Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh and calf.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
The FREEDOM Blood Glucose Monitoring System is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the FREEDOM Test Strips.
The test principle is:
This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, arm, palm, thigh, calf
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and in clinical settings
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K024194 - LifeScan, Inc. OneTouch® Ultra®, K984261 - LifeScan, Inc. SURESTEP®, K021513 - Roche Diagnostics Corp. Accu-Chek Advantage
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
American HealthCare, Inc. 510(k) for In Vitro Diagnostic Device
510(k) SUMMARY
(As required by 21.CFR.807.92)
| Introduction: | According to the requirements of 21 CFR.807.92, the following
information provides sufficient data to understand the basis for a
determination of substantial equivalence. |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | American HealthCare, Inc.
304 Park Avenue South
Suite 218
New York, NY 10010 |
| Contact Person: | Edward Letko
Phone: 917-402-5900
Fax: 212-202-5173 |
| Date Summary,
Prepared: | December 14, 2004 |
| Device Name: | Propriety Name: FREEDOM Blood Glucose Monitoring System
Common Name: Blood Glucose Test System
Classification Name: Class II, 862.1345 Glucose Blood Tester |
| Predicate Device: | We claim substantial equivalence to the LifeScan, Inc.,
OneTouch® Ultra®. |
| Device
Description: | The FREEDOM Blood Glucose Monitoring System is an in vitro
diagnostic device designed for measuring the concentration of glucose in
whole blood, which is used with the FREEDOM Test Strips.
The test principle is:
This device is an in vitro diagnostic product intended for the
measurement of glucose concentration in human blood. The principle of
the test relies upon a specific type of glucose in the blood sample, the
dehydrogenase glucose that reacts to electrodes in the test strip. The test
strip employs an electrochemical signal generating an electrical current
that will stimulate a chemical reaction. This reaction is measured by the
Meter and displayed as your blood glucose result. |
| Intended Use: | The FREEDOM Blood Glucose Monitoring System, is used for the
quantitative measurement of glucose in whole blood as an aid in
monitoring the effectiveness of diabetes management in the home and in
clinical settings. The FREEDOM Blood Glucose Monitoring System is
for |
| testing outside the body (in vitro diagnostic use only). Testing site
include the traditional fingertip testing along with alternate site
testing on the arm, palm, thigh and calf. | |
| Comparison to | |
| Predicate Device: | The US Diagnostics, Inc. FREEDOM Blood Glucose Monitoring
System is substantially equivalent to the other products in
commercial distribution intended for similar use. The most
notable, it is substantially equivalent to the currently marketed
item, the OneTouch® Ultra® by LifeScan, Inc. |
| Conclusion: | The FREEDOM Blood Glucose Monitoring System is
substantially equivalent to the following predicate devices:
K024194 - LifeScan, Inc. OneTouch® Ultra®
K984261 - LifeScan, Inc. SURESTEP®
K021513 - Roche Diagnostics Corp. Accu-Chek Advantage |
1
American HealthCare, Inc.
.
:
510(k) for In Vitro Diagnostic Device
510(k) Summary, Continued
2
Image /page/2/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 stripes extending from its head, representing the department's mission to promote health and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is simple and recognizable, conveying the department's role in public health and human services.
APR 8 2005 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Edward Letko Managing Director American HealthCare Inc. 304 Park Avenue South Suite 218 New York, NY 10010
Re: K043543
Trade/Device Name: FREEDOM Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: March 2, 2005 Received: March 2, 2005
Dear Mr. Letko
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).
3
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,
Jean M. Cooper, MS, DVM
Jean M. Cooper, MS. 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
4
Indications for Use
510(k) Number: K043543
Device Name: FREEDOM Blood Glucose Monitoring System
Indications For Use: The FREDOM Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The FREEDOM Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh and calf.
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)
Page 1 of 1
Carol Benem
Division Sign-Off
Office of in vitro Diagnostic Device Evaluation and Safety
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