(228 days)
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 theFreeStyle Precision Neo Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
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 provided text describes the FreeStyle Precision Neo Blood Glucose Monitoring System and its substantial equivalence to a predicate device. It includes performance study information for glucose measurements.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details the performance of the FreeStyle Precision Neo Blood Glucose Monitoring System against specific criteria. The key performance metrics revolve around the accuracy of glucose measurements.
Acceptance Criteria for Blood Glucose Monitoring Systems (as per ISO 15197:2003, which is commonly referenced for such devices):
- For glucose concentrations < 75 mg/dL (4.2 mmol/L): Minimum of 95% of results must be within ±15 mg/dL (±0.83 mmol/L) of the reference method.
- For glucose concentrations ≥ 75 mg/dL (4.2 mmol/L): Minimum of 95% of results must be within ±20% of the reference method.
- Overall: 99% of all individual glucose measurement results shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes.
Reported Device Performance (based on the provided text, specifically the self-testing accuracy study):
The document presents data in the following format:
A total of 152 lay users and 912 results were used for this study.
| Reference Range (mg/dL) | n | FreeStyle Precision Neo Range (mg/dL) | % Within Range |
|---|---|---|---|
| For Glucose values < 75 mg/dL | |||
| 50-75 mg/dL | 22 | within + 15 mg/dL | 100% |
| For Glucose values 75 mg/dL | |||
| 75-100 mg/dL | 167 | within + 20% | 100% |
| 101-150 mg/dL | 306 | within + 20% | 100% |
| 151-250 mg/dL | 266 | within + 20% | 99% |
| 251-400 mg/dL | 149 | within + 20% | 99% |
| Overall | 910 | 99.7% | |
| All results in Consensus Error Grid Zones A and B | 100% |
Summary Table of Acceptance Criteria and Performance:
| Performance Metric | Acceptance Criteria (e.g., ISO 15197:2003) | FreeStyle Precision Neo Performance | Evaluation |
|---|---|---|---|
| Accuracy for Glucose < 75 mg/dL | ≥ 95% of results within ±15 mg/dL of reference | 100% of 22 results within ±15 mg/dL (for 50-75 mg/dL range) | Meets Criteria (and exceeds for the specified sub-range) |
| Accuracy for Glucose ≥ 75 mg/dL | ≥ 95% of results within ±20% of reference | 100% (167 results for 75-100 mg/dL), 100% (306 results for 101-150 mg/dL), 99% (266 results for 151-250 mg/dL), 99% (149 results for 251-400 mg/dL) | Meets Criteria for the specified sub-ranges |
| Overall Accuracy (Consensus Error Grid Zones A & B) | 99% of all individual glucose measurement results in Zones A and B of CEG | 100% of all results in Consensus Error Grid Zones A and B | Meets Criteria (and exceeds) |
| Overall Agreement Rate | Not explicitly defined as a single percentage by ISO 15197 for all ranges combined | 99.7% (overall for 910 results when measured against the ±15 mg/dL / ±20% criteria) | Excellent Performance |
2. Sample Size and Data Provenance
- Sample Size for Test Set: A total of 152 lay users participated in the study, generating 912 results.
- Data Provenance: The document does not explicitly state the country of origin. It indicates Abbott Diabetes Care Inc. is based in Alameda, CA, and the legal manufacturer is Abbott Diabetes Care Ltd. in the UK, but this doesn't specify where the clinical study itself was conducted. The study is prospective, involving lay users performing self-testing.
3. Number of Experts and Qualifications for Ground Truth
The document does not provide details on the number of experts used or their qualifications for establishing ground truth. Blood glucose monitoring system studies typically use a laboratory reference method (e.g., YSI analyzer) as the ground truth, calibrated and operated by trained laboratory personnel, rather than clinical experts for ground truth establishment.
4. Adjudication Method
The document does not mention any adjudication method for the test set. For blood glucose measurements, where the ground truth is typically a precise laboratory reference method, adjudication by multiple human experts is generally not performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation is a key component, comparing human readers with and without AI assistance. This device is a quantitative measurement system for self-testing, so the performance is assessed against a reference measurement, not human interpretation.
6. Standalone Performance Study
Yes, a standalone performance study was done. The precision and accuracy data presented (e.g., the table under point 1) directly reflect the algorithm's (device's) performance compared to a reference method, without human-in-the-loop assistance influencing the measurement outcome. Lay users operated the device as intended for self-testing, but their interaction is part of the intended use, not "human-in-the-loop" for interpretation or decision-making beyond operating the device.
7. Type of Ground Truth Used
The ground truth used for the accuracy study is a reference method, likely a laboratory analyzer (e.g., YSI glucose analyzer), which is the standard for blood glucose measurement studies. This is inferred from the context of "Reference Range (mg/dL)" in the performance table.
8. Sample Size for the Training Set
The document does not specify a separate training set size or methodology. For in vitro diagnostic devices like blood glucose meters, the development process involves extensive internal validation and verification using various samples, but these are typically not referred to as "training sets" in the same way machine learning models are. The reported performance data is from a clinical study for validation.
9. How Ground Truth for the Training Set Was Established
As no specific "training set" is mentioned in the context of typical machine learning model training, the document does not describe how ground truth for such a set was established. Device development and calibration involve rigorous testing against reference methods using known glucose concentrations.
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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 RicafortTel No. 510-749-5250Fax No. 510-864-4791michelle.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 RoadWitney, OxonOX29 OYL, UK |
| U.S. Contact | Establishment:Abbott Diabetes Care Inc.1360 South Loop RoadAlameda, 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 NeoBlood Glucose MonitoringSystem | ReliOn Ultima Blood GlucoseMonitoring System (K083223) |
| CHARACTERISTICS | ||
| FundamentalTechnology | The FreeStyle Precision NeoSystem, in conjunction withblood glucose test strips,utilizes amperometrictechnology to quantitativelymeasure the glucoseconcentration in whole bloodsamples. | Same |
| Principles of Operation | Amperometry | Same |
| Glucose OperatingRange | 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 NeoBlood Glucose MonitoringSystem is for use outside thebody only (in vitrodiagnostic use) in thequantitative measurement ofglucose in fresh whole bloodfor self-testing by lay usersfrom the fingers. It is notintended to be used fortesting neonatal bloodsamples or the diagnosis orscreening of diabetes.The FreeStyle Precision NeoSystem is indicated for home(lay user) in the managementof patients with diabetes. It isintended to be used by a | The ReliOn Ultima BloodGlucose Monitoring System isintended for in vitro diagnosticuse in the quantitativemeasurement of glucose infresh whole blood for self-testing by lay users (e.g., fromthe finger, forearm, upper armor base of thumb), or by healthcare professionals. It is notintended to be used for testingneonatal blood samples.The ReliOn Ultima system isindicated for home (lay user) orprofessional use in themanagement of patients withdiabetes. |
| Proposed Device | Predicate Device | |
| PRODUCT NAME | FreeStyle Precision NeoBlood Glucose MonitoringSystem | ReliOn Ultima Blood GlucoseMonitoring System (K083223) |
| CHARACTERISTICS | single person and should notbe shared.The FreeStyle Precision NeoBlood Glucose Test Stripsare for use with the FreeStylePrecision Neo BloodGlucose Meter toquantitatively measureglucose (sugar) in freshcapillary whole bloodsamples drawn from thefingertips. | |
| Product ClassificationCode | NBW, LFR | NBW, LFR, JJX |
| Glucose Sample Types | Fresh capillary whole bloodfrom the finger | Finger, forearm, upper arm orbase of thumb |
| Compatible Test Strips | FreeStyle Precision NeoBlood Glucose Test Strips | ReliOn Ultima Blood GlucoseTest Strips |
| Glucose HematocritRange | 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.
§ 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.