TPLC - Total Product Life Cycle

• Device: vaginitis and bacterial vaginosis nucleic acid detection system
• Definition: A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.
• Product Code: PQA
• Regulation Number: 866.3975
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
CEPHEID
	SUBSTANTIALLY EQUIVALENT	3
GENEOHM SCIENCES CANADA , INC (BD DIAGNOSTICS)
	GRANTED	1
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
	SUBSTANTIALLY EQUIVALENT	1
GENEOHM SCIENCES CANADA, INC. (BD LIFE SCIENCES)
	SUBSTANTIALLY EQUIVALENT	1
HOLOGIC, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2020	2	2
2021	4	4
2022	7	7
2023	3	3
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	6	6
False Positive Result	5	5
Erratic Results	3	3
Non Reproducible Results	2	2
False Negative Result	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	12	12
No Consequences Or Impact To Patient	3	3
Insufficient Information	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Co.	II	Aug-22-2019
2	Becton Dickinson & Co.	II	Oct-31-2018