(76 days)
Lyphochek Whole Blood Immunosuppressant Controls is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The following analytes are listed in the package insert: Sirolimus, Tacrolimus, Cyclosporine. Abbott Immunosuppressant MCC is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The following analytes are listed in the package insert: Sirolimus, Tacrolimus.
Lyphochek Whole Blood Immunosuppressant Controls and Abbott Immunosuppressant MCC are both prepared from human whole blood, with added chemicals, and stabilizers.
This appears to be a 510(k) premarket notification for in-vitro diagnostic control materials, not a device that involves AI or requires the detailed study information you've requested. The provided text describes the product, its intended use, a comparison to a predicate device, and stability studies. It does not mention any AI algorithms, deep learning, imaging analysis, or human-in-the-loop performance studies that would necessitate the fields you've outlined.
Therefore, many of the requested fields cannot be filled from the provided document. I can, however, provide the acceptance criteria and the type of study mentioned for this specific device.
Acceptance Criteria and Device Performance (Based on provided text)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Open vial stability for all analytes at 2-8°C | 14 days |
| Open vial stability for all analytes at -20 to -70°C | 30 days |
| Shelf life at 2 to 8°C | 3 Years |
| Substantial equivalence to predicate device for intended use | Claimed and accepted by FDA (K072721 vs. K022041) |
| Monitor the precision of laboratory testing procedures | Intended use; performance demonstrated via stability studies |
Information that Cannot Be Extracted from the Provided Document (and why):
This document describes a quality control material used to monitor the precision of laboratory tests, not a diagnostic device that analyzes data or images and thus would not involve the following:
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to samples used in stability studies, not patient data for algorithm evaluation. The document states "All supporting data is retained on file at Bio-Rad Laboratories" but does not provide specific sample sizes or provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/imaging device would refer to clinical diagnoses or expert annotations. For a control material, "ground truth" would be the known concentration of analytes, established through analytical methods, not expert consensus.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a control material, not an AI-powered diagnostic tool for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a control material, the "ground truth" would be the certified values/concentrations of the analytes within the control, established by chemical analysis and reference methods, not expert consensus or pathology on patient data.
- The sample size for the training set: Not applicable. There is no AI model or training set.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The device's performance against its acceptance criteria is demonstrated through stability studies. These studies aim to prove that the control material maintains its integrity and expected analyte concentrations over time under specified storage conditions (shelf-life and open-vial stability). The document states:
- "Stability studies have been performed to determine the open vial stability and shelf life for this control."
- "Product claims are as follows: After reconstituting, all analytes will be stable for 14 days at 2 to 8°C or 30 days at -20 to -70°C."
- "Shelf Life: 3 Years at 2 to 8°C"
- "All supporting data is retained on file at Bio-Rad Laboratories."
The FDA's acceptance of the 510(k) (K072721) indicates that these stability studies and the comparison to the predicate device (K022041) were deemed sufficient to prove substantial equivalence and meet regulatory requirements for a Class I clinical toxicology control material.
§ 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.