(13 days)
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No
The document describes a standard electrochemical blood glucose monitoring system and does not mention any AI or ML components.
No.
The device is a monitoring system intended to measure glucose levels as an aid in monitoring the effectiveness of a diabetes control program, not to treat the condition itself.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not intended for the diagnosis of or screening for diabetes mellitus."
No
The device description explicitly states it utilizes "coulometric biosensor technology found in the FreeStyle Lite test strip" and "measures glucose electrochemically," indicating the presence of hardware components (test strips, meter) beyond just software.
Yes, the FreeStyle™ Lite Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in whole blood." This is a measurement performed in vitro (outside the body) on a biological sample (whole blood).
- Device Description: The description details the use of a "coulometric biosensor technology found in the FreeStyle Lite test strip to quantitatively measure glucose concentration in whole blood samples." This further confirms the in vitro nature of the measurement.
- Function: The device analyzes a blood sample to provide a diagnostic measurement (glucose level) that aids in monitoring a medical condition (diabetes).
The definition of an IVD device generally includes instruments, reagents, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The FreeStyle™ Lite Blood Glucose Monitoring System fits this definition by measuring glucose in a blood sample to help manage diabetes.
N/A
Intended Use / Indications for Use
The FreeStyle™ Lite Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.
The FreeStyle™ Lite Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
Product codes
NBW, LFR
Device Description
The FreeStyle™ Lite Blood Glucose Monitoring System (BGMS) utilizes coulometric biosensor technology found in the FreeStyle Lite test strip to quantitatively measure glucose concentration in whole blood samples or in FreeStyle Control Solutions. The FreeStyle Lite 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
finger, forearm, upper arm, thigh, calf and hand
Indicated Patient Age Range
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Intended User / Care Setting
healthcare professionals and people with diabetes mellitus at home
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the FreeStyle Lite Blood Glucose Monitoring System was studied in the laboratory. The results obtained during these studies demonstrated that the FreeStyle Lite Blood Glucose Monitoring System is substantially equivalent to the predicate device.
Results of laboratory testing demonstrated that the performance of the FreeStyle™ Lite Blood Glucose Monitoring System is acceptable and comparable in terms of safety and effectiveness to the performance of the predicate device for blood glucose testing when used according to its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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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).
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§ 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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Image /page/0/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "a" on the left, followed by the words "Abbott" and "Diabetes Care" stacked on top of each other. The text is in a bold, sans-serif font.
Abbott Diabetes Care Inc 1360 South Loop Road Alameda, CA 94502
t (510) 749-5400 f (510) 864-4791
LO70850
APR 1 0 2007
510(k) Summary
Per 21 CFR §807.92
| Date Prepared: | March 27, 2007 | |
|---|---|---|
| Company | Abbott Laboratories | |
| Division | Abbott Diabetes Care Inc. | |
| Street Address | 1360 South Loop Road | |
| City, State Zip | Alameda, CA 94502 | |
| Telephone No. | 510-749-5400 | |
| Fax No. | 510-864-4791 | |
| Contact Person: | Dhruma Shah | |
| Tel No. 510-749-6475 | ||
| Fax No. 510-864-4791 | ||
| dhruma.shah@abbott.com | ||
| Proprietary Name: | FreeStyle™ Lite Blood Glucose Monitoring System | |
| Common Name: | Blood Glucose Testing System, Glucose | |
| Dehydrogenase | ||
| Classification Name: | Glucose Test System (21 CFR §862.1345, Product | |
| code NBW, LFR) | ||
| Predicate Device: | FreeStyle Freedom™ Blood Glucose Monitoring | |
| System (K051839) |
Description of the Device:
The FreeStyle™ Lite Blood Glucose Monitoring System (BGMS) utilizes coulometric biosensor technology found in the FreeStyle Lite test strip to quantitatively measure glucose concentration in whole blood samples or in FreeStyle Control Solutions. The FreeStyle Lite 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 Lite Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.
The FreeStyle Lite Blood Glucose Monitoring System is intended for use in the
1
Image /page/1/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of two parts: a stylized letter 'A' on the left and the text 'Abbott Diabetes Care' on the right. The text is in a bold, sans-serif font, with 'Abbott' on the top line and 'Diabetes Care' on the bottom line.
Abbott Diabetes Care Inc 1360 South Loop Road Alameda, CA 94502
t (510) 749-5400 f (510) 864-4791
quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
| | Predicate Device
(K051839) | Subject (modified)
Device |
|--------------------------------|----------------------------------------|----------------------------------------------|
| Enzyme | PQQ dependent glucose
dehydrogenase | Same |
| Reagent Form | Test Strip | Same |
| Analyte | D-Glucose | Same |
| Detection Method | Electrochemical-(Coulometric) | Same |
| Recommended
Sample | Venous or capillary whole
blood | Same |
| Calibration | Manual calibration code entry | No manual calibration code
entry required |
| Minimum Sample
Size | 0.3 microliter (300 nanoliter) | Same |
| Measurement Range | 20-500 mg/dL | Same |
| Measurement Time | 5 seconds (average) | Same |
| Hematocrit Range | 15% to 65% | Same |
| Humidity Range | 5% to 90% | Same |
| Operating
Temperature Range | 40°-104° F | Same |
| Monitor Memory | 250 test results | 400 test results |
| Day averages | 14-day average | 7-, 14- & 30-day averages |
| Date/Time | Yes | Same |
| Communication | Serial Port | Same |
| Power Source | 3V Coin Cell Battery | Same |
Comparison to Predicate Device:
2
Image /page/2/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of the Abbott "A" symbol on the left, followed by the text "Abbott" on the top line and "Diabetes Care" on the bottom line. The text is in a sans-serif font and is black.
Abbott Diabetes Care Inc 1360 South Loop Road Alameda, CA 94502
t (510) 749-5400 f (510) 864-4791
Assessment of Non-Clinical Performance Data:
The performance of the FreeStyle Lite Blood Glucose Monitoring System was studied in The results obtained during these studies demonstrated that the the laboratory. FreeStyle Lite Blood Glucose Monitoring System is substantially equivalent to the predicate device.
Conclusion:
Results of laboratory testing demonstrated that the performance of the FreeStyle™ Lite Blood Glucose Monitoring System is acceptable and comparable in terms of safety and effectiveness to the performance of the predicate device for blood glucose testing when used according to its intended use.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 0 2007
Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502-7000 ATTN: Dhruma Shah
Re: K070850
Trade/Device Name: FreeStyle™ Lite Blood Glucose Monitoring System Regulation Number: 21 CFR $862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: March 28, 2007 Received: March 29, 2007
Dear Ms. Shah:
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
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 toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean 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
Indications for Use Statement
510(k) Number : (if known)
FreeStyle™ Lite Blood Glucose Monitoring System Device Name:
Indications for Use:
The FreeStyle™ Lite Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.
The FreeStyle™ Lite Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 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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SIQ(2) K070850