← Product Code PQP · P260004

# Signatera™ CDx (P260004)

_Natera, Inc. · PQP · May 15, 2026 · APPR_

**Canonical URL:** https://fda.innolitics.com/device/P260004

## Device Facts

- **Applicant:** Natera, Inc.
- **Product Code:** PQP
- **Decision Date:** May 15, 2026
- **Decision:** APPR
- **Device Class:** Class 3

## Regulatory Identification

A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens.

---

**Source:** [https://fda.innolitics.com/device/P260004](https://fda.innolitics.com/device/P260004)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com