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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceGuardant360 CDx
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantGuardant Health, Inc.
505 Penobscot Drive
Redwood City, CA 94063
PMA NumberP200010
Date Received02/10/2020
Decision Date08/07/2020
Product Code PQP 
Docket Number 20M-1748
Notice Date 08/28/2020
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval order for Guardant360® CDx. Guardant360® CDx is a qualitative next generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of single nucleotide variants (SNVs), insertions and deletions (indels) in 55 genes, copy number amplifications (CNAs) in two (2) genes, and fusions in four (4) genes. Guardant360 CDx utilizes circulating cell-free DNA (cfDNA) from plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes (BCTs). The test is intended to be used as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients who may benefit from treatment with the targeted therapy listed in Table 1 in accordance with the approved therapeutic product labeling. Table 1. Companion Diagnostic IndicationsIndication: Non-small cell lung cancer (NSCLC); Biomarker: EGFR exon 19 deletions, L858R, and T790M*; Therapy: TAGRISSO® (osimertinib)A negative result from a plasma specimen does not assure that the patient’s tumor is negative for genomic findings. NSCLC patients who are negative for the biomarkers listed in Table 1 should be reflexed to tissue biopsy testing for Table 1 biomarkers using an FDA-approved tumor tissue test, if feasible.*The efficacy of TAGRISSO® (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore, testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.Additionally, the test is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with solid malignant neoplasms. The test is for use with patients previously diagnosed with cancer and in conjunction with other laboratory and clinical findings. Genomic findings other than those listed in Table 1 are not prescriptive or conclusive for labeled use of any specific therapeutic product. Guardant360 CDx is a single-site assay performed at Guardant Health, Inc.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2
Supplements:  S001 S002 S004 S005 S006 S007 S008 S009 S010 S011 S013 
S014 S015 S017