(35 days)
Not Found
No
The summary describes a standard electrochemical blood glucose monitoring system and does not mention any AI or ML components.
No
The device is an in vitro diagnostic device intended to measure glucose levels, not directly treat or prevent a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "The FreeStyle Connect Blood Glucose Monitoring System is intended for in vitro diagnostic use".
No
The device description explicitly mentions a "monitor" and "test strip" which are hardware components, indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The FreeStyle Connect Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples." and "The FreeStyle Connect Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use)."
- Device Description: The description details how the device measures glucose in blood samples, which is a classic characteristic of an in vitro diagnostic test.
The term "in vitro diagnostic" means that the test is performed on samples taken from the human body (like blood) but outside of the body itself. This is exactly what a blood glucose monitoring system does.
N/A
Intended Use / Indications for Use
The FreeStyle Connect Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle Connect Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle Connect Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.
Product codes
NBW
Device Description
The FreeStyle Connect monitor utilizes coulometric biosensor technology found in the FreeStyle Connect test strip to quantitatively measure glucose concentration in whole blood samples or in FreeStyle Control Solutions. The FreeStyle Connect BGMS measures glucose electrochemically. The glucose biosensor is capable of recognizing the glucose present in whole blood by virtue of the glucose specificity of the enzyme glucose dehydrogenase (GDH) present on the glucose test strip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and in professional settings
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The performance of the FreeStyle Connect BGMS was studied in the laboratory. The results obtained during these studies demonstrated that the FreeStyle Connect BGMS is substantially equivalent to the predicate devices.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K05/802
Image /page/0/Picture/1 description: The image shows the word "ABBOTT" with a stylized "a" to the left of the word. The word is written in a simple, sans-serif font. The stylized "a" is a geometric shape that resembles a lowercase "a" but is made up of straight lines and sharp angles.
AUG 9 - 2005
Abbott Laboratories Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502
Telephone 510-749-5400 Facsimile 510-239-2799 www.abbott.com
510(k) Summary
Per 21 CFR §807.92
| Company | Abbott Laboratories / TheraSense Inc. |
|---|---|
| Division | Abbott Diabetes Care |
| Street Address | 1360 South Loop Road |
| City, State Zip | Alameda, CA 94502 |
| Phone | 510-749-5400 |
| Contact Person: | Kimberley Kline |
| 510-749-5478 | |
| kimberley.kline@abbott.com | |
| Proprietary Name: | FreeStyle Connect™ Blood Glucose Monitoring |
| System | |
| Common Name: | Blood Glucose Meter and Reagent Test Strips |
| Classification Number: | 21 CFR §862.1345 |
| Predicate Device: | Precision PCx Blood Glucose Monitor and |
| FreeStyle 600 Blood Glucose Test Strips | |
| Date Prepared: | June 30, 2005 |
Description of the Device:
The FreeStyle Connect monitor utilizes coulometric biosensor technology found in the FreeStyle Connect test strip to quantitatively measure glucose concentration in whole blood samples or in FreeStyle Control Solutions. The FreeStyle Connect BGMS measures glucose electrochemically. The glucose biosensor is capable of recognizing the glucose present in whole blood by virtue of the glucose specificity of the enzyme glucose dehydrogenase (GDH) present on the glucose test strip.
Intended Use of the Device:
The FreeStyle Connect Blood Glucose Monitoring System is intended for invitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle Connect Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle Connect Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.
1
Image /page/1/Picture/0 description: The image shows the word "ABBOTT" in a bold, sans-serif font. To the left of the word is a stylized "a" symbol, also in bold. The text and symbol are black against a white background.
| | Predicate Devices | Subject (modified)
Device |
|------------------------|---------------------------------------------------------------------------------------|------------------------------|
| Company | Abbott Laboratories | Same |
| Division | Abbott Diabetes Care | Same |
| 510(k) Reference | K022941 and K050500 | Current Submission |
| Proprietary Name: | Precision PCx Point of Care Monitor
and FreeStyle 600 Blood Glucose Test
Strips | Same |
| Common Name: | Blood Glucose Monitor and Reagent
Test Strips | Same |
| Classification Number: | 21 CFR §862.1345 | Same |
| Intended Use | Quantitative measurement of blood
glucose concentrations | Same |
| Single Use? | Yes, test strips are single use | Same |
| Sterilized? | No | Same |
Comparison to Predicate Device:
Performance Studies:
The performance of the FreeStyle Connect BGMS was studied in the laboratory. The results obtained during these studies demonstrated that the FreeStyle Connect BGMS is substantially equivalent to the predicate devices.
Conclusion:
Results of laboratory testing demonstrated that the performance of the FreeStyle Connect BGMS is acceptable and comparable to the performance of the predicate devices for blood glucose testing when used according to its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of an abstract human figure with three flowing lines representing the body. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the top and left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kimberly Kline Senior Regulatory Associate Abbott Laboratories Abbott Diabetes Care 1360 South Loop Road Alameda, CA 94502
AUG 9 - 2005
Re: K051802
Trade/Device Name: FreeStyle Connect Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 29, 2005 Received: August 1, 2005
Dear Ms. Kline:
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 cormply 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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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 (301) 594-3084. 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 Satz
Carol C. Benson, M.A. Acting 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):
FreeStyle Connect™ Blood Glucose Monitoring System Device Name:
Indications for Use:
The FreeStyle Connect Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary, venous, arterial and neonatal whole blood samples. The FreeStyle Connect Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The FreeStyle Connect Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels.
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)
C
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051802
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