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This document summarizes the device modification for the ABL90 Flex, detailing device information, intended use, performance data, and substantial equivalence to the predicate device.

How to fill out special 510k device modification

How to fill out Special 510(k): Device Modification to ABL90 Flex

1. Review the device modification guidelines provided by the FDA.
2. Gather all necessary documentation related to the original ABL90 Flex device.
3. Clearly describe the modification being made to the device.
4. Include data demonstrating that the modified device is safe and effective.
5. Prepare a summary of the changes and the rationale for the modification.
6. Complete the Special 510(k) application form accurately and thoroughly.
7. Submit the application to the FDA along with all required paperwork and fees.

Who needs Special 510(k): Device Modification to ABL90 Flex?

1. Manufacturers who have made changes to the ABL90 Flex device that require regulatory approval.
2. Companies seeking to ensure continued market access for their modified devices.
3. Entities needing to demonstrate compliance with FDA regulations for device modifications.

People Also Ask about

How long is the ABL90 flex solution pack stable onboard the ABL90 Flex?

30 Days onboard • Unopened: Manufacturer's expiration date.

What does FDA 510 K clearance mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

Can you still run a patient sample if a parameter is red in the parameter bar?

Stick the Patient ID label on the syringe. Analyse the sample by introducing the syringe to the inlet at a 45-degree angle. Before analysing the sample check that all parameters are highlighted in “green” for obtaining all results. For any parameters that are highlighted “Red” the device will not provide a result.

What does FDA 510k cleared mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is the sample volume of ABL90?

creatinine and urea the minumum capillary tube sample volume is 65 µL - C65 mode is applicable.

Is 510k the same as FDA approval?

It's important to note that clearance under the 510(k) pathway does not indicate that the FDA has approved the device but rather that the FDA has determined the device is equivalent to a similar device already on the market.

For pdfFiller’s FAQs

What is Special 510(k): Device Modification to ABL90 Flex?

The Special 510(k) process is a mechanism provided by the FDA for manufacturers to make certain modifications to an already cleared device, such as the ABL90 Flex, without needing to submit a traditional 510(k). This allows for a streamlined review process for specific types of changes that do not affect the intended use or safety and effectiveness of the device.

Who is required to file Special 510(k): Device Modification to ABL90 Flex?

Manufacturers of the ABL90 Flex are required to file a Special 510(k) for device modifications when those changes are made to an already cleared device intended for commercial distribution in the U.S.

How to fill out Special 510(k): Device Modification to ABL90 Flex?

To fill out a Special 510(k), manufacturers must complete the appropriate FDA form, providing details about the device modification, including a description of the change, information about the device's performance, labeling updates, and any relevant test data that supports the modification.

What is the purpose of Special 510(k): Device Modification to ABL90 Flex?

The purpose of the Special 510(k) for device modification is to facilitate regulatory approval for changes to an existing device that do not significantly alter its intended use, ensuring that these modifications can be evaluated and cleared more quickly by the FDA.

What information must be reported on Special 510(k): Device Modification to ABL90 Flex?

The information reported on a Special 510(k) must include the device name, the identifier for the modification, details on how the modification affects the device, summaries of testing and results, labeling changes, and any other documentation that establishes that the modified device remains safe and effective.