Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05727202
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2023-01-26
Brief Title:
Project STARFISH - PRJ0002679
Sponsor:
Thermo Fisher Scientific Inc
Organization:
Thermo Fisher Scientific Inc
Study Overview
Official Title:
IVD_ Starfish_Clinical Performance Study Protocol for US - Project STARFISH - PRJ0002679
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STARFISH
Brief Summary:
This is a non-interventional study to perform the clinical performance evaluation of the Starfish Test using prospectively collected matched nasopharyngeal and nasal swab samples from the same donor
Detailed Description:
The Applied Biosystems TaqPath COVID-19 Flu A Flu B RSV Select Panel referred to below as Starfish Test aims to develop a multiplex real-time PCR IVD test for the qualitative detection and identification of SARS-CoV-2 influenza A virus influenza B virus and respiratory syncytial virus RSV
The purpose of this performance study is to evaluate the clinical performance of the Starfish Test compared with that of a comparator device using upper respiratory specimens from subjects who have provided consent to participate in the study and meet the inclusion criteria This Clinical Performance Study Protocol CPS Protocol outlines the clinical sample collection and testing protocols which will be used to satisfy the FDA 510k study requirements in the US
The purpose of this performance study is to evaluate the clinical performance of the Starfish Test compared with that of a comparator device using upper respiratory specimens from subjects who have provided consent to participate in the study and meet the inclusion criteria This Clinical Performance Study Protocol CPS Protocol outlines the clinical sample collection and testing protocols which will be used to satisfy the FDA 510k study requirements in the US
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None