FDA.reportPublic FDA data

TruSight™ Oncology Comprehensive

Primary DI
00816270020217
Brand
TruSight™ Oncology Comprehensive
Company
ILLUMINA, INC.
Model
20032573
Device description
The TruSight Oncology Comprehensive assay is an enrichment-based targeted next generation sequencing (NGS) in-vitro diagnostic test comprised of library preparation and enrichment reagents to enable DNA and/or RNA sequencing from Formalin-Fixed, Paraffin-Embedded (FFPE) tissue from solid tumors encompassing multiple cancer types.
Published
2024-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PQPNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQPNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230011000TruSight Oncology ComprehensiveIllumina, Inc.2024-08-21PQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816270020217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816270020217008162700202178162700202170816270020217

GMDN Terms#

Term, Definition table
TermDefinition
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended for the qualitative and/or quantitative detection of mRNA expression and/or determination of the gene mutation status of multiple genes associated with cancer in a clinical specimen, using a nucleic acid technique (NAT). It is intended to be used to select treatment options, predict or monitor the response to cancer therapy and the risk of recurrence or metastasis, and/or for tumour profiling (e.g., cell-free DNA or circulating tumour DNA screening).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-809-4566techsupport@illumina.com

Regulatory Flags#

DUNS number
033305264
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816270020415Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx20063024200630242022-11-07
00816270020330DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx200747302026-04-27
00816270020644TruSight™ Oncology RNA Control200650422024-12-09
00816270020651TruSight™ Oncology DNA Control IVD200650412024-12-09
00816270020088Praxis Extended RAS Panel20012431200124312017-08-28
00816270020262Local Run Manager CF Clinical Sequencing Analysis Module20046734200467342023-06-15
00816270020286Local Run Manager CF 139 Variant Analysis Module20047009200470092023-06-15
00816270020378Local Run Manager CF 139-Variant 2.0 Micro Analysis Module20072975200729752023-06-15
00816270020385Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module20072974200729742023-06-15
00816270020149TruSight™ Cystic Fibrosis Library Preparation20036925200369252020-04-09
00816270020019MiSeqDx CF 139 Variant Assay (2 Run)15036580DX-102-10042016-09-21
00816270020026MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run)15036620DX-102-10012016-09-21
00816270020033MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run)15036577DX-102-10032017-08-14
00816270020392Local Run Manager DNA GenerateFASTQ Dx Module for MiSeq™Dx20063022200630222022-11-07
00816270020743DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx20074609200746092022-11-07
00816270020453Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples)20051352200513522022-10-20
00816270020460Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (96 samples)20051353200513532022-10-20
00816270020477Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (16 samples)20051354200513542022-10-20
00816270020484Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (16 samples)20051355200513552022-10-20
00816270020538NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles)20046931200469312022-10-18

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00860008613325MI Cancer Seek®CARIS MPI, INC.PQP2025-04-30
00850059806005Resolution ctDx FIRST Sample Collection KitResolution Bioscience, Inc.PQP2024-03-31
10190302017756Oncomine™ Dx Target Test User Guides and Assay Definition FileLIFE TECHNOLOGIES CORPORATIONPQP2022-01-23
00860001218220oncoReveal CDxPillar Biosciences, Inc.PQP2021-09-20
00860001218237oncoReveal CDx Box 2Pillar Biosciences, Inc.PQP2021-09-20
00860001218244oncoReveal CDx Box 3Pillar Biosciences, Inc.PQP2021-09-20
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00860001218275PiVAT SoftwarePillar Biosciences, Inc.PQP2021-09-20
00860001218282oncoReveal CDxPillar Biosciences, Inc.PQP2021-09-20
10190302014335Oncomine™ Dx Target RNA Control DiluentLIFE TECHNOLOGIES CORPORATIONPQP2021-01-14
10190302015134Oncomine™ DX Target DNA Control v2.0LIFE TECHNOLOGIES CORPORATIONPQP2021-01-14
10190302015646Oncomine™ Dx Target Test User Guide and Assay Definition FileLIFE TECHNOLOGIES CORPORATIONPQP2021-01-14
10190302015103Oncomine™ Dx Target TestLIFE TECHNOLOGIES CORPORATIONPQP2019-05-22
10190302000888Ion TorrentLIFE TECHNOLOGIES CORPORATIONPQP2018-06-28
10190302005845Ion TorrentLIFE TECHNOLOGIES CORPORATIONPQP2018-06-28
10190302005852Ion TorrentLIFE TECHNOLOGIES CORPORATIONPQP2018-06-28
00816270020088Praxis Extended RAS PanelILLUMINA, INC.PQP2017-08-28
10190302006385Oncomine™ Dx Target TestLIFE TECHNOLOGIES CORPORATIONPQP2017-06-27
10190302006071Oncomine™ Dx Target Test User Guides and Assay Definition FileLIFE TECHNOLOGIES CORPORATIONPQP2017-06-27
10190302006156Ion Torrent™ Dx No Template Control KitLIFE TECHNOLOGIES CORPORATIONPQP2017-06-27
10190302006064Oncomine™ Dx Target RNA Control KitLIFE TECHNOLOGIES CORPORATIONPQP2017-06-27
10190302006095Oncomine™ Dx Target DNA Control KitLIFE TECHNOLOGIES CORPORATIONPQP2017-06-27