(110 days)
MAS Tox Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in the measurement of Benzodiazepines and Barbiturates in human serum and plasma and Tricyclic Antidepressants drugs (TCA) in human serum, plasma and urine.
Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Not Found
This document is a 510(k) clearance letter from the FDA for the MAS Tox Control device. It confirms the device's substantial equivalence to a legally marketed predicate device.
However, the document DOES NOT contain information about acceptance criteria, device performance metrics, study designs (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set details for an AI/ML powered device.
This letter is for a Clinical Toxicology Control Material, which is a quality control product used to monitor the performance of assay conditions for measuring specific substances (Benzodiazepines, Barbiturates, Tricyclic Antidepressants). It is not an AI/ML-powered diagnostic device. Therefore, the requested information categories are not applicable to the content of this document.
§ 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.