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This document outlines the 510(k) premarket notification for Abbott's FreeStyle Connect Blood Glucose Monitoring System, detailing its intended use, device classification, and performance studies.
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How to fill out 510k summary for form
How to fill out 510(k) Summary for the FreeStyle Connect Blood Glucose Monitoring System
01
Gather product information: Collect all necessary details about the FreeStyle Connect Blood Glucose Monitoring System, including intended use, design specifications, and technological characteristics.
02
Identify equivalent devices: Research existing blood glucose monitoring devices that have received 510(k) clearance to establish a basis for comparison.
03
Prepare a summary of safety and effectiveness: Document how the FreeStyle Connect system is safe and effective, referencing clinical data and any performance testing results.
04
Include labeling information: Provide draft copies of the proposed labeling, including instructions for use, claims, and any contraindications.
05
Compile performance data: Include data on accuracy, precision, and any other relevant metrics that demonstrate the device’s performance.
06
Write the summary: Present the collected information in a clear, concise manner, highlighting how the FreeStyle Connect system meets the necessary regulatory requirements.
07
Review and finalize: Have colleagues or regulatory experts review the summary for completeness and accuracy before submission.
08
Submit the 510(k) application: Send the completed 510(k) Summary along with all required documents to the FDA.
Who needs 510(k) Summary for the FreeStyle Connect Blood Glucose Monitoring System?
01
Manufacturers of the FreeStyle Connect Blood Glucose Monitoring System need a 510(k) Summary to demonstrate to the FDA that their device is substantially equivalent to a legally marketed device.
02
Healthcare providers may refer to the 510(k) Summary to understand the safety and effectiveness of the device before recommending it to patients.
03
Patients using the FreeStyle Connect system can benefit from the assurance that the device has met the FDA's requirements for safety and efficacy.
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People Also Ask about
Why is my FreeStyle Libre reading so much higher than my finger stick?
Freestyle Libre and Dexcom CGMs (G7 and G6) are factory-calibrated to estimate blood glucose based on interstitial glucose - which is the fluid between skin cells. These numbers can lag behind capillary blood glucose levels (aka a finger stick readings) by ~15 minutes depending on how quickly things are changing.
What is the intended use of FreeStyle Libre?
The FreeStyle Libre flash glucose monitoring system is indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with diabetes mellitus, including pregnant women.
What is blood glucose monitoring an overview?
Blood glucose monitors are devices that measure blood glucose levels electronically. They are indicated for individuals with diabetes mellitus type 1 or 2. Traditional blood glucose monitors utilize a small drop of blood from the fingertip, placed on a disposable test strip.
How accurate is FreeStyle Libre vs blood glucose meter?
Overall blood glucose values measured by SMBG were 167.0 ± 60.1 mg/dL, and those determined by FreeStyle Libre Pro® were 155.0 ± 60.7 mg/dL, with this difference being statistically significant. The MARD for FreeStyle Libre Pro® relative to SMBG was 12.7 ± 9.3%.
What is the main purpose of blood glucose monitoring?
It gives you information on how to manage your diabetes on a daily — and sometimes even hourly — basis. Monitoring your blood sugar is important when you have diabetes, especially if you use insulin. The results of blood sugar monitoring can help you make decisions about food, physical activity and dosing insulin.
What is self monitoring of blood glucose overview?
Self-monitoring blood glucose (SMBG) is when a patient checks their own levels with a blood glucose meter. SMBG is the optimal way to confirm and appropriately treat hypoglycemia. It can provide feedback on the results of healthy behaviour interventions and antihyperglycemic pharmacological treatments.
What is the 7 point self-monitoring of blood glucose?
Meaurements: 1-before breakfast, 2-2 h after breakfast, 3-before lunch, 4-2 h after lunch, 5-before dinner, 7-before sleeping.
What is self-monitoring of blood glucose?
Self-monitoring of blood glucose provides information regarding an individual's dynamic blood glucose profile. This information can help with the appropriate scheduling of food, activity, and medication. It is also required for understanding of the timing of blood glucose variations.
Does the FreeStyle Libre patch have a needle?
NOTE: Sensor pack and sensor applicator codes must match or glucose readings may be inaccurate. CAUTION: Sensor applicators will contain a needle.
How does FreeStyle Libre measure blood glucose?
How does the FreeStyle Libre System work? Abbott's FreeStyle Libre system measures glucose levels through a small sensor applied to the back of your upper arm. The sensor, which is the size of two stacked quarters, provides real-time glucose readings for up to 10 days, both day and night3.
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What is 510(k) Summary for the FreeStyle Connect Blood Glucose Monitoring System?
The 510(k) Summary is a document submitted to the FDA that provides information about the FreeStyle Connect Blood Glucose Monitoring System, demonstrating that it is substantially equivalent to a legally marketed device. It includes details about the device's intended use, technological characteristics, and performance testing.
Who is required to file 510(k) Summary for the FreeStyle Connect Blood Glucose Monitoring System?
The manufacturer or importers of the FreeStyle Connect Blood Glucose Monitoring System are required to file the 510(k) Summary with the FDA before marketing the product.
How to fill out 510(k) Summary for the FreeStyle Connect Blood Glucose Monitoring System?
To fill out the 510(k) Summary, manufacturers must provide specific information including the applicant's details, device description, intended use, comparisons to predicate devices, performance data, and labeling information. Templates and guidelines provided by the FDA should be followed.
What is the purpose of 510(k) Summary for the FreeStyle Connect Blood Glucose Monitoring System?
The purpose of the 510(k) Summary is to ensure that the FreeStyle Connect Blood Glucose Monitoring System is safe and effective for its intended use and to demonstrate that it is comparable to similar devices already on the market.
What information must be reported on 510(k) Summary for the FreeStyle Connect Blood Glucose Monitoring System?
The 510(k) Summary must report information such as device classification, intended use, technological characteristics, performance testing results, and any labeling information relevant to the FreeStyle Connect Blood Glucose Monitoring System.
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