(116 days)
The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from an EDTA or citrate anticoagulated whole blood sample. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG® CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand- alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.
Not Found
This document is a 510(k) clearance letter for a medical device called the xTAG® CYP2D6 Kit v3. It indicates the device is substantially equivalent to legally marketed predicate devices. However, it does NOT contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets them.
The letter primarily covers the regulatory approval of the device and its intended use. It does not include:
- A table of acceptance criteria and reported device performance: This sort of data would typically be found in the 510(k) summary or the pivotal study report, not in the clearance letter itself.
- Sample sizes used for the test set and data provenance: Again, this detailed study information is not part of the clearance letter.
- Number of experts and their qualifications for ground truth: This pertains to the study design, not the FDA's regulatory decision letter.
- Adjudication method for the test set: Study design detail absent from this document.
- MRMC comparative effectiveness study details (effect size): This device is a genotyping kit, not an AI-assisted diagnostic imaging device for human readers, so an MRMC study with human readers would not be relevant or performed.
- Standalone algorithm performance: This is a lab kit, not an "algorithm" in the sense of AI software. Its performance is evaluated biochemically/molecularly.
- Type of ground truth used: While the ground truth for genetic testing is typically highly reliable reference methods (e.g., Sanger sequencing, alternative validated genotyping assays), the clearance letter doesn't specify this for this particular study.
- Sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set in that context.
- How ground truth for the training set was established: Not applicable.
In summary, the provided document does not contain the information requested in your prompt regarding acceptance criteria and study details. To find this information, you would typically need to consult the 510(k) summary submitted by the manufacturer to the FDA, which often contains a more detailed description of the performance studies.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, rendered in black.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 21, 2013
Luminex Molecular Diagnostics, Inc. c/o Lubna Syed 439 University Ave., Suite 900 TORONTO, ONTARIO M5G 1 Y8 CANADA
Re: K130189
Trade/Device Name: xTAG® CYP2D6 Kit v3 Regulation Number: 21 CFR 862.3360 Regulation Name: Drug Metabolizing Enzyme Genotyping Systems Regulatory Class: II Product Code: NTI Dated: May 6, 2013 Received: May 7, 2013
Dear Ms. Syed:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K130189
Device Name: xTAG® CYP2D6 Kit v3
Indications for Use:
The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from an EDTA or citrate anticoagulated whole blood sample. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG® CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand- alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson Jyles 2013.05.20 07:24 :00 :400 :
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K130189
§ 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.