Guardant Health, Inc.

Guardant Health, Inc. specializes in liquid biopsy tests, which analyze circulating tumor DNA (ctDNA) in a patient’s bloodstream. Their key products include Guardant360® Liquid CDx, Guardant360 CDx, and Shield. These tests help detect and monitor genetic mutations associated with cancer, enabling non-invasive diagnostics and treatment guidance without the need for tissue biopsies.

Guardant Health, Inc. is based in the United States. Their devices are regulated under the FDA’s Premarket Approval (PMA) pathway, which applies to high-risk medical devices classified as Class III in the US regulatory framework. This classification reflects the critical role these tests play in cancer diagnostics and treatment decision-making.

Guardant Health’s devices are listed under the FDA’s Premarket Approval (PMA) registry, as they fall under Class III classification. This pathway is used for devices deemed to support or sustain human life, or present a potential unreasonable risk of illness or injury. No other registries or jurisdictions are referenced for these specific products.

Guardant Health’s devices are classified as Class III because they are intended to diagnose or monitor serious conditions like cancer, where the risk of misdiagnosis or ineffective treatment could have severe consequences. Class III classification under FDA regulations applies to devices that require rigorous premarket approval to ensure safety and effectiveness, given their high-risk nature.