PQA · Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

Device class

Class II

Regulation 866.3975

Total clearances

2021-10-18 → 2026-07-16

Last 12 months

Unique sponsors

Definition

What is Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

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.

Classification details

Medical specialty

Microbiology

Review panel

Regulation number

866.3975

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Cepheid	3	0	2023-10-19
Becton, Dickinson and Company	2	0	2024-12-19
Geneohm Sciences Canada, Inc. (Bd Life Sciences)	1	0	2021-10-18
Hologic, Inc.	1	0	2024-11-25
Roche Molecular Systems, Inc.	1	1	2026-07-16

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
87491	CPT	—	High	Chlamydia trachomatis; nucleic acid detection; amplified probe technique
87492	CPT	—	High	Chlamydia trachomatis; nucleic acid detection; direct probe technique

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-16	K260021	Roche Molecular Systems, Inc.	cobas® BV/CV
2024-12-19	K243725	Becton, Dickinson and Company	BD Vaginal Panel
2024-11-25	K243345	Hologic, Inc.	Aptima BV Assay; Aptima CV/TV Assay
2023-10-19	K231381	Cepheid	Xpert Xpress MVP; GeneXpert Xpress System
2023-03-06	K223653	Becton, Dickinson and Company	BD Vaginal Panel
2022-06-07	K221160	Cepheid	Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
2022-02-09	K212213	Cepheid	Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
2021-10-18	K201017	Geneohm Sciences Canada, Inc. (Bd Life Sciences)	BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit