(356 days)
Not Found
No
The description focuses on standard electrochemical glucose measurement and simple threshold-based trend indicators, with no mention of AI or ML algorithms.
No.
The device is an in vitro diagnostic device used for measurement and monitoring of blood glucose levels, not for direct therapeutic treatment.
No
The device is explicitly stated as "not intended to be used for... the diagnosis or screening of diabetes." It is for quantitative measurement of glucose for self-testing and management of diabetes.
No
The device description explicitly details a physical meter that uses amperometric technology with test strips to measure glucose, indicating it is a hardware device with integrated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The FreeStyle Precision Neo Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use)..."
- Nature of the Test: The device measures glucose in fresh whole blood, which is a biological sample taken from the body. This is a classic characteristic of an in vitro diagnostic test.
- Purpose: The purpose is the quantitative measurement of glucose for self-testing and management of diabetes, which is a diagnostic and monitoring activity performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The FreeStyle Precision Neo Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users from the fingers. It is not intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes.
The FreeStyle Precision Neo System is indicated for home (lay user) in the management of patients with diabetes. It is intended to be used by a single person and should not be shared.
The FreeStyle Precision Neo Blood Glucose Test Strips are for use with the FreeStyle Precision Neo Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR
Device Description
The FreeStyle Precision Neo Meter is for the quantitative measurement of glucose in capillary whole blood samples. The FreeStyle Precision Neo Meter, in conjunction with the FreeStyle Precision Neo 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 System is compatible with the following components and accessories:
- . FreeStyle Precision Neo Blood Glucose Test Strips (available separately)
- MediSense Glucose and Ketone Control Solutions (available separately) ●
- USB Cable (available separately) ●
- FreeStyle Lancing Device II ●
- Thin Lancets
The FreeStyle Precision Neo System also includes a hypoglycemia and hyperglycemia trend indicators feature. The hypoglycemia/hyperglycemia trend indicators feature alerts the user of low and high blood glucose patterns. The FreeStyle Precision Neo Meter displays a red arrow indicator light if the user's blood glucose is below the set target or a vellow arrow indicator light if their blood glucose is above the set target. The default indicator target values are 70 and 240 mg/dL but can be customized, if needed. The Meter will also use these ranges to determine blood glucose patterns.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lay users from the fingers; home (lay user)
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.
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three lines that form the shape of a snake wrapped around a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2015
ABBOTT DIABETES CARE INC MICHELLE RICAFORT SENIOR REGULATORY AFFAIRS SPECIALIST 1360 SOUTH LOOP ROAD ALAMEDA CA 94502
Re: K142928
Trade/Device Name: FreeStyle Precision Neo Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. LFR Dated: September 2, 2015 Received: September 4, 2015
Dear Michelle Ricafort:
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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
FreeStyle Precision Neo Blood Glucose Monitoring System
Indications for Use (Describe)
The FreeStyle Precision Neo Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users from the fingers. It is not intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes.
The FreeStyle Precision Neo System is indicated for home (lay user) in the management of patients with diabetes. It is intended to be used by a single person and should not be shared.
The FreeStyle Precision Neo Blood Glucose Test Strips are for use with the FreeStyle Precision Neo Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
| 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 Subnart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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IDO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Specal 510k
Abbott Diabetes Care Inc. 1360 South Loop Road, Alameda, CA 94502
Image /page/3/Picture/3 description: The image shows the logo for Abbott, a global healthcare company. The logo consists of a stylized lowercase letter 'a' enclosed within a rounded square shape. The color of the logo is a solid, medium shade of blue. The design is simple, modern, and easily recognizable.
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: | 714-247-8434 |
| Fax No: | 510-864-4791 |
| Contact Person: | Michelle Ricafort |
| Tel No. 714-247-8434 | |
| Fax No. 510-864-4791 | |
| michelle.ricafort@amo.abbott.com | |
| Proprietary Name: | FreeStyle Precision Neo 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 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 |
Image /page/3/Picture/7 description: The image contains the logo for Abbott. The logo consists of a blue, stylized "A" on the left, followed by the word "Abbott" in bold, black letters. Below "Abbott" is the tagline "A Promise for Life" in a smaller, lighter font.
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Intended Use:
The FreeStyle Precision Neo Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users from the fingers. It is not intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes.
The FreeStyle Precision Neo System is indicated for home (lay user) in the management of patients with diabetes. It is intended to be used by a single person and should not be shared.
The FreeStyle Precision Neo Blood Glucose Test Strips are for use with the FreeStyle Precision Neo Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
Description of the Device:
The FreeStyle Precision Neo Meter is for the quantitative measurement of glucose in capillary whole blood samples. The FreeStyle Precision Neo Meter, in conjunction with the FreeStyle Precision Neo 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 System is compatible with the following components and accessories:
- . FreeStyle Precision Neo Blood Glucose Test Strips (available separately)
- MediSense Glucose and Ketone Control Solutions (available separately) ●
- USB Cable (available separately) ●
- FreeStyle Lancing Device II ●
- Thin Lancets
The FreeStyle Precision Neo System also includes a hypoglycemia and hyperglycemia trend indicators feature. The hypoglycemia/hyperglycemia trend indicators feature alerts the user of low and high blood glucose patterns. The FreeStyle Precision Neo Meter displays a red arrow indicator light if the user's blood glucose is below the set target or a vellow arrow
Image /page/4/Picture/15 description: The image shows the Abbott logo, which includes a stylized letter 'a' in blue, followed by the word 'Abbott' in black. Below the word 'Abbott' is the tagline 'A Promise for Life'. The text 'Proprietary and Confidential' is located at the bottom left of the image.
2
510(k) Summary
5
indicator light if their blood glucose is above the set target. The default indicator target values are 70 and 240 mg/dL but can be customized, if needed. The Meter will also use these ranges to determine blood glucose patterns.
Principles of Operation:
The FreeStyle Precision Neo Meter (in conjunction with blood glucose test strips) 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 Meter measures glucose electrically. 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.
Substantial Equivalence:
The FreeStyle Precision Neo Blood Glucose Monitoring System is substantially equivalent to the predicate, which was cleared by the Agency on September 30, 2014, to market under K140371: FreeStyle Precision Neo Blood Glucose Monitoring System in terms of indications for use, operating principle, technological characteristics and performance specifications.
Image /page/5/Picture/9 description: The image shows the Abbott logo, which consists of a blue abstract shape on the left and the word "Abbott" in bold black letters on the right. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller font. The text "Proprietary and Confidential" is located at the bottom left of the image.
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Comparison to Predicate Device:
The similarities and differences between the proposed FreeStyle Precision Neo Blood Glucose Monitoring System and the predicate (K140371) device are highlighted in the table below.
| Proposed Device | Predicate Device | |
|---|---|---|
| PRODUCT NAME | FreeStyle Precision Neo | |
| Blood Glucose Monitoring | ||
| System | FreeStyle Precision Neo Blood | |
| Glucose Monitoring System | ||
| (K140371) | ||
| CHARACTERISTICS | ||
| Fundamental Technology | The FreeStyle Precision Neo | |
| System, in conjunction with | ||
| blood glucose test strips, | ||
| 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 |
| Operating Temperature | 50° - 122°F | Same |
| Operating Humidity | 10% - 90%, non-condensing | Same |
| Power Source | CR 2032 lithium (coin cell) | |
| batteries | Same | |
| Memory | 1,000 events | Same |
| Buttons | Touch Press-Button | Same |
| Indications for Use | The FreeStyle Precision Neo | |
| Blood Glucose Monitoring | ||
| System is for use outside the | ||
| body only (in vitro | ||
| diagnostic use) in the | ||
| quantitative measurement of | ||
| glucose in fresh whole blood | ||
| for self-testing by lay users | ||
| from the fingers. It is not | ||
| intended to be used for | ||
| testing neonatal blood | Same | |
| Proposed Device | Predicate Device | |
| PRODUCT NAME | FreeStyle Precision Neo | |
| Blood Glucose Monitoring | ||
| System | FreeStyle Precision Neo Blood | |
| Glucose Monitoring System | ||
| (K140371) | ||
| CHARACTERISTICS | ||
| samples or the diagnosis or | ||
| screening of diabetes. |
The FreeStyle Precision Neo
System is indicated for home
(lay user) in the management
of patients with diabetes. It is
intended to be used by a
single person and should not
be shared.
The FreeStyle Precision Neo
Blood Glucose Test Strips
are for use with the FreeStyle
Precision Neo Blood
Glucose Meter to
quantitatively measure
glucose (sugar) in fresh
capillary whole blood
samples drawn from the
fingertips. | |
| | | |
| | | |
| Product Classification Code | NBW, LFR | Same |
| Glucose Sample Types | Fresh capillary whole blood
from the finger | Same |
| Compatible Test Strips | FreeStyle Precision Neo
Blood Glucose Test Strips | Same |
| Glucose Hematocrit Range | 15-65% | Same |
| Altitude | 10,000 feet | Same |
| Hyperglycemia/Hypoglycemia
Trend Indicator Feature | Yes | None |
Image /page/6/Picture/5 description: The image shows the Abbott logo, which consists of a blue stylized "A" symbol and the word "Abbott" in bold black letters. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller font. The text "Proprietary and Confidential" is located in the bottom left corner of the image.
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510(k) Summary
7
Image /page/7/Picture/3 description: The image shows the Abbott logo, which consists of a stylized blue square with a white "A" inside. To the right of the square is the word "Abbott" in bold, black letters. Below "Abbott" is the tagline "A Promise for Life" in a smaller font. The words "Proprietary and Confidential" are at the bottom left.
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