xTAG CYP2D6 Kit v3

• K Number: K170492
• Device Name: xTAG CYP2D6 Kit v3
• Manufacturer: Luminex Molecular Diagnostics, Inc.
• Date Cleared: 2017-08-11 ( 175 days)
• Product Code: NTI
• Regulation Number: 862.3360
• Type: Special
• Panel: TX
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

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AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a medical device called "xTAG CYP2D6 Kit V3". This type of document does not contain the detailed technical information about acceptance criteria, study methodologies, or performance data that would be necessary to answer your request.

The letter confirms that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to a legally marketed predicate device. It informs the manufacturer about regulatory obligations but does not include the specifics of the performance studies.

To get the information you are looking for (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.), you would typically need to refer to documents like:

• The 510(k) summary or 510(k) Traditional submission itself, which is often publicly available through the FDA's database.
• The device's Instruction for Use (IFU) or Product Insert, which usually contains performance data.
• Scientific publications if the study results were published in peer-reviewed journals.

Therefore, based solely on the provided document, I cannot fulfill your request for: a table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC study results, standalone performance, ground truth types, or training set details.

Regulation Number and Section

§ 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.