(59 days)
Drug Calibrator II is an in vitro diagnostic product intended for the calibration of test methods packaged in FLEXTM reagent cartridges.
Drug Calibrator II is a liquid bovine serum base product containing weighed-in quantities of purified drugs. It is packaged as 10 vials, two vials each of five levels. Each vial contains 5.0 mL.
The provided document is a 510(k) summary for a medical device called "Drug Calibrator II." This document describes the device, its intended use, and its substantial equivalence to a predicate device.
However, the document does not contain any information regarding acceptance criteria or a study that evaluates the device's performance against such criteria. It is a regulatory submission focused on demonstrating substantial equivalence for an in vitro diagnostic calibrator, not a study report detailing performance metrics.
Therefore, I cannot extract the requested information as it is not present in the provided text.
To be clear, the document:
- Does not include a table of acceptance criteria and reported device performance.
- Does not specify sample sizes for a test set, data provenance, or details about a study design.
- Does not mention experts, ground truth establishment methods, or adjudication.
- Does not discuss MRMC comparative effectiveness studies or standalone algorithm performance.
- Does not provide details on training set size or ground truth establishment for a training set.
The document is purely a descriptive regulatory filing for a calibrator product.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.