Product code QNC— Medical Genetics

Helix Laboratory Platform

Classification name: Whole Exome Sequencing Constituent Device
Device class: Class 2
Regulation: 21 CFR 866.6000
Advisory panel: Medical Genetics
Total cleared: 1
First cleared: 2020-12-23
Most recent: 2020-12-23

FDA classification definition

“A whole exome sequencing constituent device is for germline whole exome sequencing of genomic deoxyribonucleic acid (DNA) isolated from human specimens. The DNA sequence generated by this device is intended as input for clinical germline DNA assays that have FDA marketing authorization and are intended for use with this device.”
— U.S. Food and Drug Administration, device classification record for product code QNC under 21 CFR 866.6000, via openFDA

Market context for product code QNC

FDA has cleared 1 device under product code QNC, all in 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QNC

Helix Opco, LLC1 clearance

Recent clearances under product code QNC

DEN190035 — Helix Laboratory PlatformHelix Opco, LLC·2020-12-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.