# DEN190035: Helix Laboratory Platform

- Pathway: De Novo (Direct)
- Applicant: Helix Opco, LLC
- Decided: Dec 23, 2020 after 509 days
- Product code: QNC (Whole Exome Sequencing Constituent Device)
- Device class: 2
- Regulation: 21 CFR 866.6000
- 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. De Novo decisions do not claim a predicate device.

## Indications for use
The Helix Laboratory Platform is a qualitative in vitro diagnostic device intended for exome sequencing and detection of single nucleotide variants (SNVs) and small insertions and deletions (indels) in human genomic DNA extracted from saliva samples collected with Oragene® Dx OGD-610. The Helix Laboratory Platform is only intended for use with other devices that are germline assays authorized by FDA for use with this device. The device is performed at the Helix laboratory in San Diego, CA.

Source page: https://510kreport.com/device/DEN190035
Methodology: https://510kreport.com/methodology