GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL

• K Number: K063224
• Device Name: GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
• Manufacturer: GENTRIS CORPORATION
• Date Cleared: 2006-12-22 ( 59 days)
• Product Code: NZB
• Regulation Number: 866.5910
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The GentriSure™ Human Genomic DNA Reference Control (HGDRC) is an independent. external run control that is intended for use in assessing the performance of diagnostic assays that detect cytochrome p450 2D6 (CYP2D6) genetic polymorphisms. This control is not intended to be used as a substitute for controls provided with licensed test kits. GentriSure HGDRC can be used for assay validation, staff training and proficiency testing, and as a quality control in routine in vitro diagnostic testing.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the "GentriSure ™ Human Genomic DNA Reference Control". It describes the intended use of the device and confirms its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific study designs (MRMC, standalone).

Therefore, I cannot provide the requested information based on the given text. The document is primarily an administrative letter granting market clearance, not a summary of the technical study data.

Regulation Number and Section

§ 866.5910 Quality control material for cystic fibrosis nucleic acid assays.

(a)
Identification. Quality control material for cystic fibrosis nucleic acid assays. A quality control material for cystic fibrosis nucleic acid assays is a device intended to help monitor reliability of a test system by detecting analytical deviations such as those that may arise from reagent or instrument variation in genetic testing. This type of device includes recombinant, synthetic, and cell line-based DNA controls.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.” See § 866.1(e) for the availability of this guidance document.