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For measuring human haemolytic complement activity by the Classical pathway in human serum, as an aid in the diagnosis of disease associated with complement activation, and with complement component deficiencies.

Total Haemolytic Complement RID Kit

This FDA document, K992488, is a 510(k) clearance letter for a device called "Total Haemolytic Complement RID Kit." It states that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this type of document is a clearance, not a study report or a detailed performance evaluation. Therefore, it does not contain the information requested about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.

Here's why the requested information cannot be extracted from the provided text:

• 510(k) clearances focus on substantial equivalence. They confirm that a new device is as safe and effective as a legally marketed predicate device, often by demonstrating similar technological characteristics and indications for use. They do not typically provide the detailed clinical study data or performance metrics that would be found in a full study report or premarket approval (PMA) application.
• The document is a letter, not a scientific paper. It's a regulatory communication from the FDA to the manufacturer, not a publication describing a study's methodology and results.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample size, or ground truth based solely on the provided text.

To obtain the requested information, one would need to access the original 510(k) submission document (if publicly available) or any associated clinical study reports that the manufacturer submitted to the FDA to support their claim of substantial equivalence. These documents would contain the detailed performance data, acceptance criteria, and study methodologies.

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