(104 days)
The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP450 2C19 gene, located on chromosome 10q24, from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples. The xTAG CYP2C19 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP2C19 gene product, specifically *2, *3 and *17. The kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.
The xTAG® CYP2C19 Kit v3 is indicated for use with the Luminex® 100/200™ instrument or MAPGIX® with xPONENT® software systems.
Not Found
The provided text describes the 510(k) clearance for the xTAG® CYP2C19 Kit v3. While it lists the device name, regulation details, and indications for use, it does not contain any information about acceptance criteria, device performance from a study, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested table and study details from the given input. The document is essentially the FDA's clearance letter and the "Indications for Use" statement, not a performance study report.
To answer your request, I would need a different document that details the device's validation study, including:
- Methods and results of performance testing.
- Specific acceptance criteria used for the study.
- The breakdown of data provenance and sample sizes.
- Details on how ground truth was established and by whom.
- Information on MRMC studies or standalone performance.
§ 862.3360 Drug metabolizing enzyme genotyping system.
(a)
Identification. A drug metabolizing enzyme genotyping system is a device intended for use in testing deoxyribonucleic acid (DNA) extracted from clinical samples to identify the presence or absence of human genotypic markers encoding a drug metabolizing enzyme. This device is used as an aid in determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme about which the system provides genotypic information.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping Test System.” See § 862.1(d) for the availability of this guidance document.