(46 days)
Lyphochek Whole Blood Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Lyphochek Whole Blood Control is prepared from human whole blood with added pure chemicals. The control is provided in lyophilized form for increased stability.
This document is a 510(k) summary for the Lyphochek Whole Blood Control. It describes the device, its intended use, and claims substantial equivalence to an existing device. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, study data, or ground truth establishment.
Therefore, I cannot provide a table of acceptance criteria or details about a study that proves the device meets specific performance standards based on the provided text. The document focuses on regulatory approval (510(k) clearance) based on substantial equivalence to an older product, not on presenting detailed performance study data against defined acceptance criteria.
The information that is available in the document, which might be tangentially related but does not fully answer the prompt, includes:
- Device Performance (Implicit): The device is intended "to monitor the precision of laboratory testing procedures" for analytes like Cyclosporine, Lead, and Red Cell Folate. Its performance is implied to be similar to its predicate device.
- Sample Size/Data Provenance: Not mentioned for any test set to prove acceptance criteria.
- Experts/Ground Truth: Not mentioned in the context of establishing acceptance criteria or study outcomes.
- Adjudication Method: Not applicable as no study with expert review is described.
- MRMC Study: Not applicable.
- Standalone Performance: Not applicable in the context of what's described.
- Type of Ground Truth: Not applicable.
- Training Set Sample Size/Ground Truth: Not applicable as this is not an AI/algorithm-based device requiring training.
The document is a regulatory submission for a quality control material, not a data-driven performance study report for an AI or diagnostic device with explicit acceptance criteria.
§ 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.