(17 days)
The xTAG® Cystic Fibrosis 60 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transment conductance regulator (CFTR) gene in human blood specimens. The panel includes mutations and variants currently recommended by the American Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG), plus some of the world's most common and North American-prevalent mutations. The xTAG Cystic Fibrosis 60 Kit v2 is a qualitative genotyping test that provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children.
The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes.
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The provided text is a 510(k) premarket notification letter for the Luminex Molecular Diagnostics xTAG® Cystic Fibrosis 60 Kit v2. This document is a regulatory approval letter and does not contain the detailed study information typically found in a clinical trial report or a scientific publication. Therefore, I cannot provide all the requested information.
However, based on the nature of the device (a molecular diagnostic kit for detecting genetic mutations), I can infer some aspects and explicitly state what is not present in the document.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. A 510(k) clearance letter acknowledges substantial equivalence to a predicate device but does not typically detail the specific performance metrics (like sensitivity, specificity, accuracy) or the pre-defined acceptance criteria from the validation studies.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document. The letter does not describe the specific studies conducted, including sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided document. For genetic testing, ground truth would typically be established by Sanger sequencing or another highly accurate molecular method, not by human experts in the way that imaging studies use radiologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document. Adjudication methods are typically relevant for subjective assessments, which is not the primary mode of operation for a genetic diagnostic kit.
5. 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
This information is not applicable and not available in the provided document. This device is a genetic testing kit, not an AI-assisted diagnostic tool that involves human readers interpreting images or other data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is partially applicable but not detailed in the provided document. The xTAG® Cystic Fibrosis 60 Kit v2 is a qualitative genotyping test. This implies it operates in a "standalone" fashion in terms of detecting mutations, producing results without human interpretive input beyond running the assay and reading the output. However, the letter does not provide details of such a "standalone performance" study or its results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a genetic testing kit, the ground truth would typically be established by a gold standard molecular method, such as:
- Sanger Sequencing: Considered the gold standard for definitive mutation identification.
- Next-Generation Sequencing (NGS): Can also be used to confirm mutations.
- Reference materials with known genotypes: Commercially available or laboratory-validated samples with confirmed mutation status.
However, the specific method used for establishing ground truth for the xTAG® Cystic Fibrosis 60 Kit v2 is not detailed in this document.
8. The sample size for the training set
This information is not available in the provided document. This type of device does not typically have a "training set" in the machine learning sense. Instead, assay development involves extensive analytical validation and clinical validation studies.
9. How the ground truth for the training set was established
This information is not applicable and not available in the provided document. As mentioned, this is not an AI/machine learning device with a training set.
§ 866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
(a)
Identification. The CFTR gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the CFTR gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation, or population screening.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System.” See § 866.1(e) for the availability of this guidance document.