(20 days)
Reference Material for Delta-9-THC-COOH in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte in human urine.
Reference Material for Delta-9-THC-COOH in Human Urine
The provided text is a 510(k) clearance letter from the FDA for a Reference Material for Delta-9-THC-COOH in Human Urine. This type of device is a calibration or control material used to verify the accuracy of laboratory tests (specifically GC/MS methods) for detecting a marijuana metabolite.
The information you are asking for, such as acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment, is not typically found in a 510(k) clearance letter.
A 510(k) clearance letter primarily states that the FDA has reviewed the device and determined it to be "substantially equivalent" to a legally marketed predicate device. This equivalence is based on the data and information provided by the manufacturer in their 510(k) submission, which would contain the study details. However, the clearance letter itself only summarizes the FDA's decision, not the full details of the supporting studies.
Therefore, I cannot provide the requested information from the given document.
To answer your questions, I would need access to the actual 510(k) submission which would include the performance data and study reports.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.