Search Results

The ONTRAK TESTCUP and TESTSTIK Controls are in vitro diagnostic devices intended for use as quality control samples for use with the ONTRAK TESTCUP and TESTSTIK systems for amphetamine, cocaine, cannabinoids (THC), morphine, phencyclidine (PCP), and barbiturates.

ONTRAK TESTCUP™ and TESTSTIK Controls

I am sorry, but the provided text from the FDA 510(k) letter for the ONTRAK TESTCUP® AND TESTSTIK Controls does not contain the specific information required to complete your request about acceptance criteria and a study proving device performance.

The document is a clearance letter indicating that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It does not include:

• Acceptance criteria and reported device performance: This information would typically be found in a summary of the device's performance data, not in the regulatory clearance letter itself.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone studies, type of ground truth, training set sample size, or how training ground truth was established. These details are part of a technical study report that supports the 510(k) submission, not the clearance letter.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device