Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3975](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3975) → PQA — Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System # PQA · Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System _Microbiology · 21 CFR 866.3975 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PQA ## Overview - **Product Code:** PQA - **Device Name:** Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System - **Regulation:** [21 CFR 866.3975](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3975) - **Device Class:** 2 - **Review Panel:** [Microbiology](/submissions/MI) ## Identification A device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis is a qualitative in vitro diagnostic device intended for the detection of microbial nucleic acid sequences in vaginal specimens collected from patients with signs and symptoms of vaginitis or bacterial vaginosis. This device is intended to aid in the diagnosis of vaginitis or bacterial vaginosis when used in conjunction with clinical signs and symptoms and other laboratory findings. ## Classification Rationale Class II (special controls). The special controls for this device are: ## Special Controls *Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include: (i) Documentation with a detailed device description of device components; ancillary reagents required but not provided; and explanation of the methodology including primer/probe sequence, design, and rationale for sequence selection. (ii) Documentation with information that demonstrates the performance characteristics of the device, including: (A) Limit of Detection; (B) Precision (reproductivity); (C) Analytical specificity; (D) Analytical reactivity (inclusivity); (E) Specimen stability; and (F) Effects of interfering substances. (iii) Detailed documentation from a prospective clinical study. As appropriate to the intended use, the prospective clinical study must be performed on an appropriate study population, including women of various ages and ethnicities. The prospective clinical study must compare the device performance to results obtained from well-accepted comparator methods. (iv) Detailed documentation for device software, including software applications and hardware-based devices that incorporate software. (2) The labeling required under § 809.10(b) of this chapter must include: (i) A detailed explanation of the interpretation of results and acceptance criteria; (ii) For devices with an intended use that includes detection of nucleic acid sequences from bacteria associated with bacterial vaginosis, clinical performance stratified by patient demographics such as race, ethnicity, age, and pregnancy status. (iii) For devices with an intended use that includes detection of nucleic acid sequences from bacteria associated with bacterial vaginosis, a summary of device results in an asymptomatic population with demographic characteristics appropriate to the intended use population. (iv) For devices with an intended use that includes detection of either Candida species or bacteria associated with bacterial vaginosis, a limitation that *Candida* species and bacterial compositions associated with bacterial vaginosis can be present as part of normal vaginal flora and results should be considered in conjunction with available clinical information. ## Recent Cleared Devices (11 of 11) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243725](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PQA/K243725.md) | BD Vaginal Panel | Becton, Dickinson and Company | Dec 19, 2024 | SESE | | [K243345](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PQA/K243345.md) | Aptima BV Assay; Aptima CV/TV Assay | Hologic, Inc. | Nov 25, 2024 | SESE | | [K231381](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PQA/K231381.md) | Xpert Xpress MVP; GeneXpert Xpress System | Cepheid | Oct 19, 2023 | SESE | | [K223653](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PQA/K223653.md) | BD Vaginal Panel | Becton, Dickinson and Company | Mar 6, 2023 | SESE | | [K221160](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PQA/K221160.md) | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | Jun 7, 2022 | SESE | | [K212213](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PQA/K212213.md) | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System | Cepheid | Feb 9, 2022 | SESE | | [K201017](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PQA/K201017.md) | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | Oct 18, 2021 | SESE | | [K191957](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PQA/K191957.md) | BD MAX Vaginal Panel | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | Oct 21, 2019 | SESE | | [K190452](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PQA/K190452.md) | Aptima BV Assay | Hologic, Inc. | May 23, 2019 | SESE | | [K190472](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PQA/K190472.md) | Aptima CV/TV Assay | Hologic, Inc. | May 16, 2019 | SESE | | [DEN160001](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PQA/DEN160001.md) | BD MAX Vaginal Panel, BD MAX Instrument | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | Oct 28, 2016 | DENG | ## Top Applicants - Cepheid — 3 clearances - Hologic, Inc. — 3 clearances - Becton, Dickinson and Company — 2 clearances - Geneohm Sciences Canada, Inc. (Bd Diagnostics) — 2 clearances - Geneohm Sciences Canada, Inc. (Bd Life Sciences) — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PQA](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PQA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com