(636 days)
The Chromsystems MassCheck Immunosuppressant Whole Blood Controls are in vitro diagnostic devices intended to verify performance of various laboratory assay systems that measure cyclosporine, tacrolimus, or sirolimus.
The Chromsystems MassCheck Immunosuppressant Controls are Ivophilized, multi-analyte human whole blood based products containing the analytes Ciclosporin A, Rapamycin (Sirolimus) and Tacrolimus. The Controls are available as four levels + blank. Prior to use the different lyophilized controls need to be reconstituted by adding the corresponding amount of water as indicated on the respective packing leaflet. Each donor was tested and found negative for Human immunodeficiency virus (HIV) 1 and 2, Hepatitis B virus (HBV), Hepatitis C virus (HCV) in European blood banks. The tests used were cleared for in vitro diagnostic use in the EU (in compliance with the European Directive 98/79/EC on in vitro Diagnostic Medical Devices as Annex II, List A products) and are also approved by the Paul-Ehrlich-Institute in Germany.
The document provided is a 510(k) summary for the Chromsystems MassCheck Immunosuppressants Whole Blood Controls. This type of device is a control material used to verify the performance of laboratory assay systems that measure concentrations of immunosuppressant drugs.
Based on the information provided in the document, here's a breakdown regarding acceptance criteria, study details, and related aspects:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary does not explicitly state specific acceptance criteria in terms of numerical thresholds (e.g., ±X% accuracy, Y% precision).
It also does not report specific performance data for the Chromsystems MassCheck Immunosuppressants Whole Blood Controls.
Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices. The claim of substantial equivalence is based on the following similarities:
| Feature | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate devices | Verified: Intended to verify performance of laboratory assay systems for cyclosporine, tacrolimus, or sirolimus. |
| Analytes | Same as predicate devices | Verified: Ciclosporin A, Rapamycin (Sirolimus), Tacrolimus. |
| Matrix | Similar to predicate devices | Verified: Human whole blood based products. |
| Format | Supplied lyophilized and requires reconstitution | Verified: Supplied lyophilized and requires reconstitution. |
| Safety Testing (Donor Blood) | Negative for HIV 1 and 2, HBV, HCV (in compliance with EU directive and approved by Paul-Ehrlich-Institute in Germany) | Reported as tested and found negative. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a specific "test set" in the context of a performance study with a defined sample size for the proposed device itself, nor does it specify data provenance (country of origin, retrospective/prospective).
The submission relies on a comparison to predicate devices, implying that the performance of the proposed device is expected to be similar to that of the already legally marketed predicates. The comparison focuses on the characteristics and intended use rather than new clinical performance data from a specific test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable or provided in the 510(k) summary. Given that the device is a control material and the submission aims for substantial equivalence based on product characteristics rather than a diagnostic performance claim, there is no mention of an expert panel establishing ground truth for a test set.
4. Adjudication Method for the Test Set:
This information is not applicable or provided for the same reasons as above. No adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described. This type of study is typically performed for diagnostic imaging or screening devices to assess human reader performance with and without AI assistance. The MassCheck Immunosuppressants Whole Blood Controls are laboratory control materials, not diagnostic AI systems for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone (algorithm only) performance study was not described. The device is a physical control material, not an algorithm. Its "performance" is in its stability, accuracy of stated concentrations, and ability to challenge an assay system appropriately. These characteristics are typically validated through analytical studies, not an algorithm-only performance study.
7. The Type of Ground Truth Used:
For the purpose of this 510(k) (seeking substantial equivalence for a control material):
- The "ground truth" for the analytes (Ciclosporin A, Rapamycin (Sirolimus), and Tacrolimus) in the control material would be their known, precisely manufactured concentrations.
- The "ground truth" for the safety of the human whole blood matrix is based on testing for specific pathogens (HIV 1 and 2, HBV, HCV) using cleared in vitro diagnostic tests in EU blood banks.
However, the document does not elaborate on how the precise concentrations of the analytes within the controls were verified or how the controls were analytically characterized. The focus is on the device's intended use as a control, not on its own diagnostic accuracy against a gold standard in patient samples.
8. The Sample Size for the Training Set:
This information is not applicable or provided. The device is a manufactured control product, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable or provided for the same reason as above.
§ 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.