(228 days)
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No
The summary describes a standard blood glucose monitoring system using amperometric technology. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the chemical reaction and electrical measurement of glucose.
No.
The device measures glucose levels but is not involved in treatment or therapy. It is an in vitro diagnostic device used for monitoring and management of diabetes, not for therapeutic intervention.
Yes
Explanation: The "Intended Use/Indications for Use" section explicitly states that the device is "for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood." This directly aligns with the definition of a diagnostic device. While it also states "It is not intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes," this clarifies its specific diagnostic scope rather than negating its diagnostic nature. Its purpose is to measure glucose to aid in the management of diabetes, which is a diagnostic-related activity.
No
The device description explicitly mentions a "FreeStyle Precision Neo Meter" which is a hardware component, and the system works in conjunction with test strips and other accessories, indicating it is a hardware-based system with potentially embedded software.
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 a blood sample, which is a biological specimen taken from the body and tested in vitro (outside the body).
- Purpose: The purpose is to provide quantitative measurement of glucose for self-testing and management of diabetes, which falls under the scope of IVD devices used for diagnosis, monitoring, or screening of diseases or conditions.
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
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 ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fingers, fingertips
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lay users, 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)
The results obtained from performance studies and clinical studies demonstrate that the FreeStyle Precision Neo Blood Glucose Monitoring System is safe and effective for its intended use and technological characteristics, and therefore, substantially equivalent to the predicate device (K083223).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
K083223: ReliOn Ultima Blood Glucose Monitoring System
Reference Device(s)
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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2014
ABBOTT DIABETES CARE, INC. MICHELLE RICAFORT SENIOR REGULATORY AFFAIRS SPECIALIST 1360 SOUTH LOOP ROAD ALAMEDA CA 94502
Re: K140371
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 19, 2014 Received: September 22, 2014
Dear Ms. 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.
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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.
Courtney
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) K140371
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) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ |
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Abbott Diabetes Care Inc. 1360 South Loop Road,
Alameda, CA 94502
Image /page/3/Picture/1 description: The image shows the logo for Abbott, a healthcare company. The logo is a stylized letter "a" in a rounded, sans-serif font. The color of the logo is a light blue. The logo is simple and modern.
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: | Michelle Ricafort |
| Tel No. 510-749-5250 | |
| Fax No. 510-864-4791 | |
| michelle.ricafort@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: | ReliOn Ultima Blood Glucose Monitoring System (K083223) |
| 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/5 description: The image shows the logo for Abbott. The logo consists of a blue, stylized letter "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 ●
Image /page/4/Picture/12 description: The image shows the logo for Abbott. The logo consists of a blue square with a stylized "a" inside, 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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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 April 16, 2009, to market under K083223: ReliOn Ultima Blood Glucose Monitoring System. The results obtained from performance studies and clinical studies demonstrate that the FreeStyle Precision Neo Blood Glucose Monitoring System is safe and effective for its intended use and technological characteristics, and therefore, substantially equivalent to the predicate device (K083223).
Comparison to Predicate Device:
The similarities and differences between the FreeStyle Precision Neo Blood Glucose Monitoring System and the predicate (K083223) are highlighted in the table below.
Image /page/5/Picture/8 description: The image contains the Abbott logo. The logo consists of a blue stylized "A" on the left, followed by the word "Abbott" in black, bold font. Below "Abbott" is the tagline "A Promise for Life" in a smaller, lighter font.
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| Proposed Device | Predicate Device | |
|---|---|---|
| PRODUCT NAME | FreeStyle Precision Neo | |
| Blood Glucose Monitoring | ||
| System | ReliOn Ultima Blood Glucose | |
| Monitoring System (K083223) | ||
| 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 | 450 events |
| Buttons | Touch Press-Button | Keypad |
| 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 | The ReliOn Ultima Blood | |
| Glucose Monitoring System is | ||
| intended for in vitro diagnostic | ||
| use in the quantitative | ||
| measurement of glucose in | ||
| fresh whole blood for self- | ||
| testing by lay users (e.g., from | ||
| the finger, forearm, upper arm | ||
| or base of thumb), or by health | ||
| care professionals. It is not | ||
| intended to be used for testing | ||
| neonatal blood samples. | ||
| The ReliOn Ultima system is | ||
| indicated for home (lay user) or | ||
| professional use in the | ||
| management of patients with | ||
| diabetes. | ||
| Proposed Device | Predicate Device | |
| PRODUCT NAME | FreeStyle Precision Neo | |
| Blood Glucose Monitoring | ||
| System | ReliOn Ultima Blood Glucose | |
| Monitoring System (K083223) | ||
| CHARACTERISTICS | 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 | NBW, LFR, JJX |
| Glucose Sample Types | Fresh capillary whole blood
from the finger | Finger, forearm, upper arm or
base of thumb |
| Compatible Test Strips | FreeStyle Precision Neo
Blood Glucose Test Strips | ReliOn Ultima Blood Glucose
Test Strips |
| Glucose Hematocrit
Range | 15-65% | 30-60% |
| Altitude | 10,000 feet | 7,200 feet |
Image /page/6/Picture/1 description: The image contains the Abbott logo. The logo 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, lighter font.
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Image /page/7/Picture/1 description: The image contains the Abbott logo. The logo 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 phrase "A Promise for Life" in a smaller, lighter font.