(92 days)
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No
The document describes a standard blood glucose monitoring system based on amperometric technology, with no mention of AI or ML capabilities.
No.
The device is an in vitro diagnostic device used to measure glucose levels, not to provide therapy.
Yes
The device is described as an "in vitro diagnostic use" system that measures glucose to monitor the effectiveness of a diabetes control program, which are characteristics of a diagnostic device. While it explicitly states "should not be used for the diagnosis of or screening for diabetes," its role in monitoring a diagnosed condition falls under the broader definition of diagnostic and management tools.
No
The device description explicitly mentions a "FreeStyle Precision Neo H Meter" which is a hardware component used for measuring glucose. The system also includes test strips and a USB cable, further indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use section explicitly states: "The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use)."
Furthermore, the device measures glucose in blood samples, which is a biological specimen, and the testing is performed outside of the living organism. This aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and in venous and arterial whole blood.
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.
The system should not be used for the diagnosis of or screening for diabetes or for neonatal testing.
The Freestyle Precision Neo H Blood Glucose Test Strips are for use with the Freestyle Precision Neo H Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood from the finger, and from venous and arterial whole blood.
Product codes
NBW, LFR
Device Description
The FreeStyle Precision Neo H meter provides the following features:
- Quantitative measurement of glucose in capillary, venous and arterial whole blood samples
- Quality Control Reminder
- Out-of-Range Indicators
The FreeStyle Precision Neo H Meter is for use by healthcare professionals (HCPs) for multiple-patient use. The FreeStyle Precision Neo H Meter, in conjunction with the FreeStyle Precision Neo H Blood Glucose Test Strips, works on the principal of amperometric technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions, through electrical mediation.
The FreeStyle Precision Neo H System is compatible with the following components and accessories:
- FreeStyle Precision Neo H Blood Glucose Test Strips
- MediSense Glucose and Ketone Control Solutions
- FreeStyle Auto-Assist Neo Data Management System
- USB Cable
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
Indicated Patient Age Range
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Intended User / Care Setting
professional healthcare 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The results obtained from performance studies and clinical studies demonstrate that the FreeStyle Precision Neo H Blood Glucose Monitoring System is safe and effective for its intended use and technological characteristics, and therefore, substantially equivalent to the predicate device (K132511).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2016
ABBOTT DIABETES CARE INC. ARUL STERLIN ASSOCIATE DIRECTOR, REGULATORY AFFAIRS 1360 SOUTH LOOP ROAD ALAMEDA CA 94202
Re: K153330
Trade/Device Name: FreeStyle Precision Neo H Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: November 23, 2015 Received: November 24, 2015
Dear Arul Sterlin:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Katherine Serrano -S
For:
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153330
Device Name
FreeStyle Precision Neo H Blood Glucose Monitoring System
Indications for Use (Describe)
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and in venous and arterial whole blood.
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.
The system should not be used for the diagnosis of or screening for diabetes or for neonatal testing.
The Freestyle Precision Neo H Blood Glucose Test Strips are for use with the Freestyle Precision Neo H Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood from the finger, and from venous and arterial whole blood.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Abbott Laboratories. The logo is a stylized lowercase letter "a" enclosed in a rounded square. The letter and the square are both the same shade of blue.
510(k) Summary
According to the requirements per 21 CFR §807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| Date Prepared: | February 17, 2016 |
|---|---|
| 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: | Arul Sterlin |
| Tel No. 510-864-4310 | |
| Fax No. 510-864-4791 | |
| arul.sterlin@abbott.com | |
| Proprietary Name: | FreeStyle Precision Neo H Blood Glucose Monitoring System |
| Common Name: | Glucose Test System |
| Classification | |
| Name: | Glucose Dehydrogenase, Glucose, Class II (21 CFR§ 862.1345) |
| Product codes: NBW, LFR | |
| Predicate Device: | FreeStyle Precision Pro Blood Glucose and Beta-Ketone Monitoring |
| System (K132511) | |
| Legal | |
| Manufacturer: | Establishment: |
| Abbott Diabetes Care Ltd. | |
| Range Road | |
| Witney, Oxon | |
| OX29 OYL, UK | |
| U.S. Contact | Establishment: |
| Abbott Diabetes Care Inc. | |
| 1360 South Loop Road | |
| Alameda, CA 94502 |
Image /page/3/Picture/4 description: The image shows the Abbott logo. The logo consists of a blue stylized letter "a" on the left and the word "Abbott" in black on the right. Below the word "Abbott" is the phrase "A Promise for Life" in a smaller font.
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Intended Use:
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and in venous and arterial whole blood.
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with singleuse, auto-disabling lancing devices.
The system should not be used for the diagnosis of or screening for diabetes or for neonatal testing.
The Freestyle Precision Neo H Blood Glucose Test Strips are for use with the Freestyle Precision Neo H Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood from the finger, and from venous and arterial whole blood.
Description of the Device:
The FreeStyle Precision Neo H meter provides the following features:
- . Quantitative measurement of glucose in capillary, venous and arterial whole blood samples
- Quality Control Reminder
- . Out-of-Range Indicators
The FreeStyle Precision Neo H Meter is for use by healthcare professionals (HCPs) for multiple-patient use. The FreeStyle Precision Neo H Meter, in conjunction with the FreeStyle Precision Neo H Blood Glucose Test Strips, works on the principal of amperometric technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions, through electrical mediation.
The FreeStyle Precision Neo H System is compatible with the following components and accessories:
- . FreeStyle Precision Neo H Blood Glucose Test Strips
- . MediSense Glucose and Ketone Control Solutions
- FreeStyle Auto-Assist Neo Data Management System ●
- . USB Cable
Image /page/4/Picture/17 description: The image shows the Abbott logo. The logo consists of a blue stylized letter "a" on the left, followed by the word "Abbott" in black, bold font. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller, lighter font.
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Principles of Operation:
The FreeStyle Precision Neo H Meter (in conjunction with blood glucose test strips) utilizes amperometric technology to quantitatively measure the glucose concentration in whole blood samples (capillary from the finger tip, venous and arterial) and in MediSense Glucose & Ketone Control Solutions.
The FreeStyle Precision Neo H Meter measures glucose electrically. The glucose biosensor is capable of recognizing the glucose present in whole blood or control solutions by virtue of the glucose specificity of the enzyme GDH present on the glucose test strip. The electrons liberated by this reaction are transferred via a co-factor and mediator to the meter where they are read as a small electrical current. The size of the current is directly proportional to the level of the glucose in the applied sample.
The apply blood symbol is displayed for the user to apply blood to the test strip until the meter begins the test. The meter detects trigger current from the test strip when enough blood has covered the strip electrodes and the test countdown will start. When the countdown is complete a test result is displayed on the meter screen. The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user.
Substantial Equivalence:
The FreeStyle Precision Neo H Blood Glucose Monitoring System is substantially equivalent to the predicate, which was cleared by the Agency on December 24, 2013, to market under K132511: FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System. The results obtained from performance studies and clinical studies demonstrate that the FreeStyle Precision Neo H Blood Glucose Monitoring System is safe and effective for its intended use and technological characteristics, and therefore, substantially equivalent to the predicate device (K132511).
Image /page/5/Picture/6 description: The image shows the logo for Abbott. The logo consists of a stylized blue letter "a" on the left, followed by the word "Abbott" in a bold, dark font. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller, lighter font. The logo is clean and professional, conveying a sense of trust and reliability.
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Comparison to Predicate Device:
The similarities and differences between the FreeStyle Precision Neo H Blood Glucose
Monitoring System and the predicate (K132511) are highlighted in the table below.
| Proposed Device | Predicate Device | |
|---|---|---|
| PRODUCT NAME | FreeStyle Precision Neo H | |
| Blood Glucose Monitoring System (K153330) | FreeStyle Precision Pro Blood | |
| Glucose and Beta-Ketone | ||
| Monitoring System (K132511) | ||
| CHARACTERISTICS | ||
| Fundamental Technology | The FreeStyle Precision Neo H System (in conjunction with blood glucose test strips) utilizes amperometric technology to quantitatively measure the glucose concentration in whole blood samples. | Same |
| Glucose Hematocrit Range | 15-65% | Same |
| Glucose Operating Range | 20-500 mg/dL | Same |
| Use Life | 3 years | Same |
| Cleaning and | ||
| Disinfection Cycles | 10,950 cycles validated | Same |
| Operating Humidity | 10-90% | Same |
| Glucose Sample volume | 0.6 microliters | Same |
| Glucose Hematocrit | ||
| Compensation | Yes | Same |
| Glucose Assay Time | 5 seconds | Same |
| Operating Temperature | 59° to 104°F | Same |
| Proposed Device | Predicate Device | |
| FreeStyle Precision Neo H | FreeStyle Precision Pro Blood | |
| PRODUCT NAME | Blood Glucose Monitoring | |
| System (K153330) | Glucose and Beta-Ketone | |
| Monitoring System (K132511) | ||
| CHARACTERISTICS | ||
| Indications for Use | The Freestyle Precision Neo H | |
| Blood Glucose Monitoring | ||
| System is intended for the | ||
| quantitative measurement of | ||
| glucose (sugar) in fresh | ||
| capillary whole blood from the | ||
| finger, and in venous and | ||
| arterial whole blood when used | ||
| within 30 minutes after | ||
| collection. | The Freestyle Precision Pro | |
| Blood Glucose and β-Ketone | ||
| Monitoring System is intended | ||
| for the quantitative measurement | ||
| of glucose (sugar) in fresh | ||
| capillary whole blood from the | ||
| finger, and from venous, arterial | ||
| and neonatal whole blood, and | ||
| for the quantitative | ||
| measurement of β- ketone (beta- | ||
| hydroxybutyrate) in flesh | ||
| capillary whole blood from the | ||
| finger and venous, arterial, and | ||
| neonatal whole blood when used | ||
| within 30 minutes after | ||
| collection. | ||
| The Freestyle Precision Neo H | ||
| Blood Glucose Monitoring | ||
| System is intended for testing | ||
| outside the body (in vitro | ||
| diagnostic use). It is intendedfor multiple-patient use in | ||
| professional healthcare | ||
| settings as an aid to monitor | ||
| the effectiveness of a diabetes | ||
| control program. This system | ||
| should only be used with | ||
| single-use, auto-disabling | ||
| lancing devices. | The Freestyle Precision Pro | |
| Blood Glucose and β-Ketone | ||
| Monitoring System is intended | ||
| for testing outside the body (in | ||
| vitro diagnostic use) and is | ||
| intended for multiple-patient use | ||
| in professional healthcare | ||
| settings as an aid to monitor the | ||
| effectiveness of a diabetes | ||
| control program. This system | ||
| should only be used with single | ||
| use, auto-disabling lancing | ||
| devices. | ||
| The system should not be | ||
| used for the diagnosis of or | ||
| screening for diabetes. | The system should not be used | |
| for the diagnosis of or screening | ||
| for diabetes. | ||
| The Freestyle Precision Pro | ||
| Blood Glucose Test Strips are for | ||
| use with the Freestyle Precision | ||
| Proposed Device | Predicate Device | |
| FreeStyle Precision Neo H | FreeStyle Precision Pro Blood | |
| PRODUCT NAME | Blood Glucose Monitoring | |
| System (K153330) | Glucose and Beta-Ketone | |
| Monitoring System (K132511) | ||
| CHARACTERISTICS | ||
| The Freestyle Precision Neo | ||
| H Blood Glucose Test Strips | ||
| are for use with the Freestyle | ||
| Precision Neo H Meter to | ||
| quantitatively measure | ||
| glucose (sugar) in fresh | ||
| capillary whole blood sample | ||
| drawn from the fingertips, and | ||
| from venous and arterial | ||
| whole blood. | Pro Blood Glucose and β-Ketone | |
| Meter to quantitatively measure | ||
| glucose (sugar) in fresh capillary | ||
| whole blood samples drawn from | ||
| the fingertips and from venous, | ||
| arterial. and neonatal whole | ||
| blood. The Freestyle Precision | ||
| Pro Blood β-Ketone Test Strips | ||
| are for use with the Freestyle | ||
| Precision Pro Blood Glucose and | ||
| P-Ketone Meter to quantitatively | ||
| measure β-ketone in fresh | ||
| capillary whole blood samples | ||
| drawn from the fingertips and | ||
| from venous, arterial, and | ||
| neonatal whole blood. |
Freestyle Precision Pro Blood
Glucose and β-Ketone
Monitoring System enables
automatic transmission of stored
data to a data management
system using the docking station
(optional), a data upload cable
(optional), or wirelessly
(optional) in a WiFi enabled
facility when the meter and data
management systems are
properly configured. |
| Product Classification
Code | NBW, LFR | NBW, JIN, JQP, LFR |
| Glucose Sample Types | Fresh capillary whole blood
from the finger, venous and
arterial whole blood samples | Fresh capillary whole blood
from the finger, venous, arterial,
and neonatal whole blood
samples |
| Calibration | ROM | Barcode scanner |
| Altitude | 10,000 feet above sea level | 7,200 feet above sea level |
| Data Management
System | FreeStyle Auto Assist Neo
Data Management System | Precision Web Point-of-Care
Health Management System |
| Data Upload | USB Data Cable | USB Data Cable, Docking
Station, Wireless |
| | Proposed Device | Predicate Device |
| PRODUCT NAME | FreeStyle Precision Neo H
Blood Glucose Monitoring
System (K153330) | FreeStyle Precision Pro Blood
Glucose and Beta-Ketone
Monitoring System (K132511) |
| CHARACTERISTICS | | |
| Compatible Test Strips | FreeStyle Precision Neo H
Blood Glucose Test Strips | FreeStyle Precision Pro Blood
Glucose Test Strips and
FreeStyle Precision Pro Blood
$ \u03b2 $ -Ketone Test Strips |
Image /page/6/Picture/4 description: The image shows the Abbott logo. The logo consists of a blue symbol on the left and the word "Abbott" in black on the right. Below the word "Abbott" is the phrase "A Promise for Life" in a smaller font.
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Image /page/7/Picture/1 description: The image contains the Abbott logo and company name. The logo is a stylized letter 'a' in blue. To the right of the logo is the company name, 'Abbott', in a bold, dark font. Below the company name is the tagline 'A Promise for Life' in a smaller, lighter font.
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Image /page/8/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue stylized letter 'a' on the left, followed by the word 'Abbott' in bold, black letters. Below the word 'Abbott' is the tagline 'A Promise for Life' in a smaller, lighter font.
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Image /page/9/Picture/1 description: The image contains the Abbott logo. The logo consists of a stylized letter 'a' in blue, followed by the word "Abbott" in bold, black letters. Below the word "Abbott" is the phrase "A Promise for Life" in a smaller, lighter font.