(91 days)
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No
The document describes a standard blood glucose test strip using amperometric technology and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) product used to measure glucose levels, which informs treatment decisions but does not directly deliver therapy or treat a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test strips are "for use outside the body only (in vitro diagnostic use)" and "to quantitatively measure glucose (sugar) in fresh capillary whole blood samples." This indicates its purpose is to diagnose or monitor a condition (diabetes) by analyzing biological samples.
No
The device description explicitly states that the device is a physical test strip that works in conjunction with a meter, utilizing amperometric technology and chemical reactions. This indicates a hardware component is central to its function.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The FreeStyle Precision Neo Blood Glucose Test Strips are for use outside the body only (in vitro diagnostic use)..."
This statement directly identifies the device as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The FreeStyle Precision Neo Blood Glucose Test Strips are for use outside the body only (in vitro diagnostic use) with the FreeStyle Libre Reader's built-in meter as components of the Flash Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. They are not intended to be used for testing neonatal blood samples or screening of diabetes.
The FreeStyle Precision Neo Blood Glucose Test Strips are indicated for home (lay) user in the management of patients with diabetes. They are intended to be used by a single person and should not be shared.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
The FreeStyle Precision Neo Blood Glucose Test Strips are used for the quantitative measurement of glucose in capillary whole blood samples. The FreeStyle Precision Neo Blood Glucose Test Strips, in conjunction with the FreeStyle Libre Reader's built-in meter, 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 Blood Glucose Test Strips are compatible with the FreeStyle Precision Neo Blood Glucose Meter (cleared under K140371) or the FreeStyle Libre Reader's built-in meter.
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
fingertips
Indicated Patient Age Range
Not intended to be used for testing neonatal blood samples.
Intended User / Care Setting
home (lay) user
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)
Clinical and performance testing was conducted with the FreeStyle Precision Neo Blood Glucose Test Strips and FreeStyle Libre Reader's built-in meter. Performance testing included analysis of precision, linearity and detection limits, interference, environmental conditions, sample volume and infection control studies. A clinical study was performed to assess the device accuracy compared to YSI reference.
The results obtained from clinical and performance studies show that all performance characteristics were met. The results demonstrate that the FreeStyle Precision Neo Blood Glucose Test Strips are safe and effective for its intended use and technological characteristics when used with the FreeStyle Libre Reader's built-in meter, and therefore, substantially equivalent to the predicate device (K140371).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that features a stylized representation of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 27, 2017
ABBOTT DIABETES CARE INC. STEPHANIE YUN SR. REGULATORY AFFAIRS SPECIALIST 1360 SOUTH LOOP ROAD ALAMEDA, CA 94502
Re: K171941
Trade/Device Name: FreeStyle Precision Neo Blood Glucose Test Strips Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW Dated: August 31, 2017 Received: September 5, 2017
Dear Stephanie Yun:
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.
1
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,
Kellie B. Kelm -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) K171941
Device Name
FreeStyle Precision Neo Blood Glucose Test Strips
Indications for Use (Describe)
The FreeStyle Precision Neo Blood Glucose Test Strips are for use outside the body only (in vitro diagnostic use) with the FreeStyle Libre Reader's built-in meter as components of the Flash Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. They are not intended to be used for testing neonatal blood samples or screening of diabetes.
The FreeStyle Precision Neo Blood Glucose Test Strips are indicated for home (lay) user in the management of patients with diabetes. They are intended to be used by a single person and should not be shared.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | X Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue, stylized letter "a" on the left, followed by the text "Abbott" in bold, black letters. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.
K171941 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.
| 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: | Stephanie Yun |
| Tel No. 510-239-2689 | |
| Fax No. 510-864-4791 | |
| stephanie.yun@abbott.com | |
| Proprietary Name: | FreeStyle Precision Neo Blood Glucose Test Strips |
| Common Name: | Glucose Test System |
| Classification | |
| Name: | System, Test, Blood Glucose, Over The Counter, Class II (21 CFR § |
| 862.1345) | |
| Product codes: NBW | |
| Predicate Device: | FreeStyle Precision Neo Blood Glucose Monitoring System (K140371) |
| 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 |
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Image /page/4/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue, stylized "a" on the left, followed by the text "Abbott" in bold, black letters on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.
Intended Use:
The FreeStyle Precision Neo Blood Glucose Test Strips are for use outside the body only (in vitro diagnostic use) with the FreeStyle Libre Reader's built-in meter as components of the FreeStyle Libre Flash Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. They are not intended to be used for testing neonatal blood samples or for the diagnosis or screening of diabetes.
The FreeStyle Precision Neo Blood Glucose Test Strips are indicated for home (lay) user in the management of patients with diabetes. They are intended to be used by a single person and should not be shared.
Description of the Device:
The FreeStyle Precision Neo Blood Glucose Test Strips are used for the quantitative measurement of glucose in capillary whole blood samples. The FreeStyle Precision Neo Blood Glucose Test Strips, in conjunction with the FreeStyle Libre Reader's built-in meter, 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 Blood Glucose Test Strips are compatible with the FreeStyle Precision Neo Blood Glucose Meter (cleared under K140371) or the FreeStyle Libre Reader's built-in meter.
Principles of Operation:
The FreeStyle Precision Neo Blood Glucose Test Strips (in conjunction with a compatible blood glucose meter) utilizes amperometric technology to quantitatively measure the glucose concentration in capillary whole blood samples from the fingertip and in MediSense Glucose & Ketone Control Solutions.
The FreeStyle Precision Neo Blood Glucose Test Strips measures glucose electrically when used in conjunction with a compatible blood glucose meter. The glucose biosensor is capable of recognising 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.
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Image /page/5/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a blue, stylized "a" on the left, followed by the text "Abbott" in bold, black letters on the top line. Below "Abbott" is the text "Diabetes Care" in a smaller, non-bold font, also in black.
Substantial Equivalence:
The FreeStyle Precision Neo Blood Glucose Test Strips are substantially equivalent to the predicate test strips, which were cleared by the Agency on September 30, 2014, to market under K140371: FreeStyle Precision Neo Blood Glucose: Monitoring System and Test Strips.
The purpose of this submission is to expand the indications for use of the test strips to now include compatibility with the FreeStyle Libre Reader's built-in meter, in addition to the existing FreeStyle Precision Neo Blood Glucose Meter. There is no change to the fundamental technology of the test strip cleared under K140371.
Summary of Clinical and Performance Testing:
Clinical and performance testing was conducted with the FreeStyle Precision Neo Blood Glucose Test Strips and FreeStyle Libre Reader's built-in meter. Performance testing included analysis of precision, linearity and detection limits, interference, environmental conditions, sample volume and infection control studies. A clinical study was performed to assess the device accuracy compared to YSI reference.
Conclusions from Clinical and Performance Evaluations:
The results obtained from clinical and performance studies show that all performance characteristics were met. The results demonstrate that the FreeStyle Precision Neo Blood Glucose Test Strips are safe and effective for its intended use and technological characteristics when used with the FreeStyle Libre Reader's built-in meter, and therefore, substantially equivalent to the predicate device (K140371).
Comparison to Predicate Device:
The similarities and differences between the FreeStyle Precision Neo Blood Glucose Test Strips and the predicate test strips (K140371) are highlighted in Tables 1 and 2 below.
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Image /page/6/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized blue "a" on the left, followed by the words "Abbott" in bold black font and "Diabetes Care" in a regular black font on the right. The logo is simple and modern, with a focus on the company's name and area of expertise.
| Proposed Device | Predicate Device | |
|---|---|---|
| FreeStyle Precision Neo | FreeStyle Precision Neo Blood | |
| PRODUCT NAME | Blood Glucose Test Strips | Glucose Monitoring System(K140371) |
| CHARACTERISTICS | ||
| Fundamental | ||
| Technology | The FreeStyle Precision Neo | |
| Blood Glucose Test Strips, in | ||
| conjunction with blood | ||
| glucose meter, utilizes | ||
| amperometric technology to | ||
| quantitatively measure the | ||
| glucose concentration in | ||
| whole blood samples. | Same | |
| Principles of Operation | Amperometry | Same |
| Glucose Operating | ||
| Range | 20-500 mg/dL | Same |
| Chemistry | GDH-NAD | Same |
| Glucose Sample volume | 0.6 microliters | Same |
| Glucose Assay Time | 5 seconds | Same |
| Coding (Calibration) | No coding required | Same |
| Sample Application | Top or end fill | Same |
| Operating Temperature | 59° - 104°F | Same |
| Operating Humidity | 10% - 90%, non-condensing | Same |
| Product Classification | ||
| Code | NBW | NBW, LFR |
| Glucose Sample Types | Fresh capillary whole blood | |
| from the finger | Same | |
| Glucose Hematocrit | ||
| Range | 15-65% | Same |
| Altitude | 10,000 feet | Same |
Table 1: Similarities between the Proposed and Predicate Device
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Image /page/7/Picture/0 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized blue "a" on the left, followed by the words "Abbott" in bold black font and "Diabetes Care" in a regular black font on the right. The logo is simple and modern, with a focus on the company's name and area of expertise.
| Proposed Device | Predicate Device | |
|---|---|---|
| PRODUCT NAME | FreeStyle Precision Neo Blood Glucose Test Strips | FreeStyle Precision Neo Blood Glucose Monitoring System(K140371) |
| CHARACTERISTICS | ||
| Indications for Use | ||
| (for Test Strip) | The FreeStyle Precision Neo Blood Glucose Test Strips are for use outside the body only (in vitro diagnostic use) with the FreeStyle Libre Reader's built-in meter as components of the FreeStyle Libre Flash Glucose Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. They are not intended to be used for testing neonatal blood samples or for the diagnosis or screening of diabetes. | |
| The FreeStyle Precision Neo Blood Glucose Test Strips are indicated for home (lay) user in the management of patients with diabetes. They are intended to be used by a single person and should not be shared. | The FreeStyle Precision Neo Blood Glucose Test Strips are for use outside the body only (in vitro diagnostic use) with the FreeStyle Precision Neo Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. They are not intended to be used for testing neonatal blood samples or for the diagnosis or screening of diabetes. | |
| The FreeStyle Precision Neo Blood Glucose Test Strips are indicated for home (lay) user in the management of patients with diabetes. They are intended to be used by a single person and should not be shared. |