(40 days)
The MAS Immunosuppressant Controls, consisting of levels 1 through 3, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine, sirolimus, and tacrolimus.
MAS Immunosuppressant Controls is prepared from human whole blood, with pure chemicals and stabilizers. The control is provided in a liquid form containing Cyclosporine, Sirolimus, and Tacrolimus.
The provided document is a 510(k) premarket notification for a medical device called "MAS Immunosuppressant Controls." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics and acceptance criteria in the way one might expect for a novel diagnostic algorithm or clinical treatment device.
Therefore, many of the requested categories for defining acceptance criteria and study details cannot be directly extracted from this document, as they are not typically part of a 510(k) for a quality control material. Specifically, this submission does not contain information on device performance in terms of sensitivity, specificity, accuracy, or a clinical study with human readers or pathology ground truth.
However, I can extract the information that is present and indicate where the requested information is not applicable or not provided in this specific type of submission.
Acceptance Criteria and Device Performance
This 510(k) submission for MAS Immunosuppressant Controls does not present specific quantitative acceptance criteria or detailed performance data in the typical sense of a diagnostic device (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is claimed based on comparable intended use, physical properties, and a demonstration that the device is safe and effective for its stated purpose as a quality control material.
The implied acceptance criteria are that the control material performs similarly to the predicate device in its intended function: monitoring the precision of laboratory testing procedures for specific immunosuppressants. The study supporting this is a comparison to a predicate device, not an independent performance study against a clinical gold standard.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Assayed QC material for monitoring precision of lab testing for cyclosporine, sirolimus, tacrolimus. | Matches: The MAS Immunosuppressant Controls' intended use aligns directly with monitoring precision for these analytes. |
| Matrix: Processed Human Whole Blood. | Matches: Subject device uses Processed Human Whole Blood. |
| Analyte Inclusion: Cyclosporine, Sirolimus, Tacrolimus. | Matches: Subject device contains these three analytes. |
| Number of Levels: Three (3) levels. | Matches: Subject device offers three (3) levels. |
| Open Vial Claim: 14 days at 2°C to 8°C. | Matches: Subject device claims 14 days at 2°C to 8°C. |
| Storage: Stability until expiration date when stored at relevant temperature. | Matches: Subject device is stable until expiration date at -20°C (for the subject device) or 2°C to 8°C (for the predicate). |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of patient samples or a traditional test set. The comparison is between the control materials themselves. The submission does not detail any "test set" of patient data.
- Data Provenance: Not applicable. The study is a comparison of product characteristics and intended use, not based on clinical data or patient samples from a specific country or collected retrospectively/prospectively.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable: There is no "ground truth" expert review in the context of this 510(k) submission for a quality control material. The ground truth for individual analyte concentrations in control materials is established through a precise manufacturing and assaying process, not expert consensus on patient data.
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Adjudication Method for the Test Set:
- Not Applicable: No adjudication method is mentioned as there is no test set in the conventional sense requiring expert review or adjudication.
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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 is a 510(k) for a quality control material, not an AI-assisted diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is not an algorithmic device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the traditional sense: For quality control materials, the "ground truth" for the declared values of the controls is established through the precise manufacturing process and subsequent validated analytical testing of the controls themselves, often against reference methods or certified reference materials, to assign the assayed values. It is not derived from clinical outcomes, pathology, or expert consensus on patient data.
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The sample size for the training set:
- Not Applicable: This device does not involve a training set for an algorithm.
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How the ground truth for the training set was established:
- Not Applicable: No training set is involved.
§ 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.