# K063224: Gentrisure Human Genomic Dna Reference Control

- Pathway: 510(k) (Traditional)
- Applicant: Gentris Corporation
- Decided: Dec 22, 2006 after 59 days
- Product code: NZB (Quality Control Material, Genetics, Dna)
- Device class: 2
- Regulation: 21 CFR 866.5910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The GentriSure TM 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.

Source page: https://510kreport.com/device/K063224
Methodology: https://510kreport.com/methodology