TPLC - Total Product Life Cycle

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Device	multi-target respiratory specimen nucleic acid test including sars-cov-2 and other microbial agents
Definition	A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.
Product Code	QOF
Regulation Number	866.3981
Device Class	2

Premarket Reviews
Manufacturer	Decision
BD INTEGRATED DIAGNOSTIC SOLUTIONS/
	SUBSTANTIALLY EQUIVALENT	1
BIOFIRE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
BIOFIRE DIAGNOSTICS, LLC
	GRANTED	1
	SUBSTANTIALLY EQUIVALENT	2
CEPHEID®
	SUBSTANTIALLY EQUIVALENT	1
DIASORIN MOLECULAR LLC
	SUBSTANTIALLY EQUIVALENT	1
HOLOGIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
LUMINEX CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LUMINEX MOLECULAR DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE MOLECULAR SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2023	6	6
2024	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	8	8
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Erratic Results	1	1
Device Contaminated at the User Facility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11	11
Insufficient Information	1	1