Get the free 510(k) Summary for Precision® Point of Care Blood Glucose Test Strips - accessdata fda

Document detailing the premarket notification and substantial equivalence determination for Abbott's Precision® and Optium® Point of Care Blood Glucose Test Strips, indicating their intended use

How to fill out 510k summary for precision

How to fill out 510(k) Summary for Precision® Point of Care Blood Glucose Test Strips

1. Begin by gathering all necessary product information, including product name, intended use, and device description.
2. Compile information on the principles of operation and the technology underlying the Precision® Point of Care Blood Glucose Test Strips.
3. Include detailed specifications such as performance characteristics, accuracy, and precision data.
4. Summarize any clinical performance data, ensuring to highlight any comparisons to a predicate device.
5. Document quality control procedures and assure compliance with applicable FDA regulations.
6. Fill out the 510(k) cover sheet and submit all required documentation, including the completed 510(k) summary.
7. Review the submission for accuracy and completeness before sending it to the FDA.

Who needs 510(k) Summary for Precision® Point of Care Blood Glucose Test Strips?

1. Manufacturers of the Precision® Point of Care Blood Glucose Test Strips need the 510(k) Summary to demonstrate safety and effectiveness.
2. Healthcare facilities and providers intending to use the device must ensure it has proper FDA clearance through the 510(k) Summary.
3. Regulatory professionals involved in medical device submissions require the 510(k) Summary to comply with FDA regulations.

People Also Ask about

What is the normal range for glucose in point of care?

As a result, the ADA now recommends a glucose range of 140-180 mg/dl (7.8-10 mmol/l) in critically ill inpatients and premeal glucose target <140 mg/dl (7.8 mmol/l) with random glucose target <180 mg/dl (10 mmol/l) in insulin treated non–critically ill inpatients, and less stringent targets for those with severe

What is coding on glucose test strips?

Glucose test strips vary slightly from batch to batch. These variations are accounted for by a batch-specific “code”: a set of parameters defining the relationship between the signal change induced on the glucose test strip and the blood glucose concentration.

What is the reference range for blood glucose levels obtained by point of care testing?

As a result, the ADA now recommends a glucose range of 140-180 mg/dl (7.8-10 mmol/l) in critically ill inpatients and premeal glucose target <140 mg/dl (7.8 mmol/l) with random glucose target <180 mg/dl (10 mmol/l) in insulin treated non–critically ill inpatients, and less stringent targets for those with severe

What is the point of care glucose range?

Random non-fasting glucose Point of Care Testing (POCT) ranges: AgeCapillary whole blood Glucose (mmol/L) 0-29 days 2.6 - 8.0 30d - 14yr 4 - 7 15yr and above 4 - 11

What is the purpose of point of care blood glucose testing?

Point-of-care testing (POCT) for glucose at the bedside or in the home or hospital is used to monitor patients with diabetes—not to establish the diagnosis of diabetes mellitus. Successful POCT for glucose in the hospital requires the formation of an administrative committee with membership from all affected areas.

What is the normal range for POCT?

Rationale: The expected values for normal fasting blood glucose concentration are between 70 mg/dL (3.9 mmol/L) and 100 mg/dL (5.6 mmol/L). When fasting blood glucose is between 100 to 125 mg/dL (5.6 to 6.9 mmol/L) changes in lifestyle and monitoring glycemia are recommended.

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What is 510(k) Summary for Precision® Point of Care Blood Glucose Test Strips?

The 510(k) Summary for Precision® Point of Care Blood Glucose Test Strips provides a concise overview of the device's intended use, technological characteristics, and any evidence demonstrating that the device is safe and effective for its intended purpose. It serves as a premarket notification to the FDA to inform them about the decision to market the device.

Who is required to file 510(k) Summary for Precision® Point of Care Blood Glucose Test Strips?

The manufacturer or importer of the Precision® Point of Care Blood Glucose Test Strips must file the 510(k) Summary with the FDA in order to obtain clearance before the product can be marketed.

How to fill out 510(k) Summary for Precision® Point of Care Blood Glucose Test Strips?

To fill out the 510(k) Summary, the filer should include detailed information about the device, including its description, intended use, technological characteristics, substantial equivalence to predicate devices, performance testing results, and labeling information. The form should be completed in accordance with FDA guidelines.

What is the purpose of 510(k) Summary for Precision® Point of Care Blood Glucose Test Strips?

The purpose of the 510(k) Summary is to demonstrate that the Precision® Point of Care Blood Glucose Test Strips are as safe and effective as a legally marketed device. It serves as a means of communication between the manufacturer and the FDA regarding the device's compliance with regulations.

What information must be reported on 510(k) Summary for Precision® Point of Care Blood Glucose Test Strips?

The information that must be reported includes the device name, applicant's details, intended use, description, predicate device information, comparative analysis, performance testing data, and labeling, including instructions for use and safety information.