(189 days)
The PAXgene™ Blood RNA System consists of a blood collection tube (PAXgene™ Blood RNA Tube) and nucleic acid purification kit (PAXgene™ Blood RNA Kit). It is intended for the collection, storage, and transport of blood and stabilization of intracellular RNA in a closed tube and subsequent isolation and purification of host RNA from whole blood for RT-PCR used in molecular diagnostic testing.
Performance characteristics for the PAXgene™ Blood RNA System have only been established with "cfos and IL1B." The user is responsible for establishing appropriate PAXgene™ Blood RNA System performance characteristics for other target transcripts.
PAXgene Blood RNA Kit is for the purification of intracellular RNA from whole blood collected in the PAXgene Blood RNA Tube. When the kit is used in conjunction with the PAXgene Blood RNA Tube, the system provides purified intracellular RNA from whole blood for RT-PCR used in molecular diagnostic testing.
Performance characteristics for the PAXgene Blood RNA System have only been established with FOS and IL1B gene transcripts. The user is responsible for establishing appropriate PAXgene Blood RNA System performance characteristics for other target transcripts.
The PAXgene™ Blood RNA System consists of:
- PAXgene™ Blood RNA tubes
- · PAXgene™ Blood RNA kit.
The PAXgene™ Blood RNA tube is of a sterile, plastic, evacuated blood collection tube containing stabilization solution (tetradecyl trimethyl-ammonium oxalate and tartaric acid. These components serve to lyse cells, protect RNA molecules from degradation by ribonucleases (RNases) and prevent induction of gene expression. The kit consists of 5 aqueous buffer solutions for resuspending, binding, washing, and eluting RNA, RNase-free water, proteinase K. an RNase-Free DNase set, spin columns, microcentrifuge tubes, processing tubes, and secondary blood collection tube closures.
Here's an analysis of the provided text regarding the PAXgene™ Blood RNA System, focusing on the acceptance criteria and the study proving it, as per your requested format:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary (K082150) does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a readily extractable table format. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K042613) by showing that the RNA obtained using the updated system (with QIAcube automation) is "compatible with molecular diagnostic applications such as mRNA transcript level determination by RT-PCR."
The core assertion is: "Therefore the processing of RNA by the automated protocol on QIAGEN's QIAcube is equivalent to the manual process as described in K042613."
Implicit Acceptance Criteria (derived from the justification of equivalence):
| Acceptance Criteria Category | Specific Criteria (Implicit from Equivalence Claim) | Reported Device Performance |
|---|---|---|
| RNA Compatibility | RNA obtained using the automated protocol on QIAGEN's QIAcube must be compatible with molecular diagnostic applications. | "The RNA obtained from the QIAcube is compatible with molecular diagnostic applications such as mRNA transcript level determination by RT-PCR." |
| Equivalence to Predicate | The automated RNA purification process must be equivalent to the manual process of the predicate device (K042613) for RNA quality and quantity. | "the processing of RNA by the automated protocol on QIAGEN's QIAcube is equivalent to the manual process as described in K042613." |
| Target Transcripts | Performance characteristics for "cfos and IL1B" must be maintained. (This is an existing statement from the predicate's intended use and not a new criterion for this submission). | Performance for cfos and IL1B is implicitly maintained due to demonstrated equivalence to the predicate, which had established performance for these. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). The information provided is very high-level, stating only that "Design Control activities performed demonstrated the RNA obtained from the QIAcube is compatible..." This suggests an internal validation study, but no details on the participants or samples are given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The study described is a technical validation of RNA compatibility, not a diagnostic study requiring expert consensus on clinical ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as the study did not involve human interpretation or a "test set" in the sense of comparing human reads or diagnostic outcomes. It was an analytical performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging or interpretation where different readers evaluate cases. The PAXgene™ Blood RNA System is a pre-analytical device for RNA purification.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The study described could be considered a form of "standalone" evaluation in that it evaluates the automated RNA purification process (the "algorithm" or automated protocol) on QIAGEN's QIAcube in isolation, without involving human interpretation of the purification process itself. However, "standalone" usually refers to the performance of a diagnostic algorithm independent of human input in the diagnostic decision. Here, the "performance" is the quality and yield of the RNA. The document focuses on demonstrating that the RNA produced by the automated system is equivalent to that produced by the manual system of the predicate device, for subsequent molecular diagnostic testing.
7. Type of Ground Truth Used
The "ground truth" in this context is the quality and quantity of RNA deemed acceptable for downstream molecular diagnostic applications, specifically RT-PCR, as well as the equivalence to the RNA produced by the predicate manual method. This is established through the "Design Control activities" and presumably involved analytical measurements (e.g., RNA yield, purity, integrity, and successful amplification of target transcripts like cfos and IL1B). It is an analytical validation against established laboratory standards and the performance of the predicate.
8. Sample Size for the Training Set
This information is not applicable/not provided. The PAXgene™ Blood RNA System is a chemical and mechanical system for RNA purification; it does not involve machine learning or AI models that require a "training set" in the conventional sense. The "training" here would be the development and optimization of the automated protocol itself.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as point 8. The "ground truth" for developing the automated protocol would have been achieving optimal RNA quality and yield comparable to the manual method, established through iterative testing and analytical measurements.
§ 866.4070 RNA Preanalytical Systems.
(a)
Identification. RNA Preanalytical Systems are devices intended to collect, store, and transport patient specimens, and stabilize intracellular RNA from the specimens, for subsequent isolation and purification of the intracellular RNA for RT-PCR used in in vitro molecular diagnostic testing.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification System for RT-PCR Used in Molecular Diagnostic Testing).” See § 866.1(e) for the availability of this guidance document.