Aptima BV Assay; Aptima CV/TV Assay
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Aptima CV/TV Assay EUDAMEDAptima® FDA UDI
- Generic Name
- Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Aptima CV/TV Assay EUDAMEDAptima® CV/TV assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. FDA UDI
- Model / Reference
- PRD-05189 EUDAMEDKIT, BOX 2, ROOM TEMPERATURE, ACV/TV, 100T, IVD FDA UDI
- Description
- Aptima® CV/TV assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. FDA UDI
Identifiers
- Catalog Number
- ASY-11570 FDA UDI
- Primary DI / UDI-DI
- 15420045512078 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455DIAGAPTCVTV2E EUDAMED
- Direct Marketing DI
- 15420045512078 EUDAMED
- FDA Product Code
- PQA FDA 510(k)FDA UDINSU FDA UDI
- EMDN Code
- W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS EUDAMED
- GMDN Term
- Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Models / Variants
Classification
- Device Class
- Class C EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 866.3975 FDA 510(k)
- Regulation Number
- 866.3975 FDA 510(k)FDA UDI862.2570 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The Aptima BV Assay and Aptima CV/TV Assay are nucleic acid detection systems for diagnosing bacterial vaginosis (BV) and candidal vaginitis/trichomoniasis (CV/TV), respectively. Classified as a Vaginitis and Bacterial Vaginosis Nucleic Acid Detection System, these assays detect specific microbial targets to aid in the identification of infections in symptomatic women. The devices operate under the regulatory framework of the In Vitro Diagnostic Regulation (IVDR) and have received FDA 510(k) clearance through a Special Review process by the Microbiology (MI) Advisory Committee.
These assays are designed for use on the Panther® system and require a vaginal swab sample collected via the Aptima multitest swab specimen collection kit. Supplied as a single-use diagnostic tool, the assays are intended for laboratory settings and must be handled according to manufacturer guidelines. Authorized under FDA 510(k) clearance (K243345) and IVDR compliance, they adhere to regulatory standards for microbiological diagnostics, ensuring accuracy and reliability in detecting BV, Candida species, and Trichomonas vaginalis.
Frequently asked questions
What types of infections can the Aptima BV Assay and Aptima CV/TV Assay detect, and how do they differ in their diagnostic focus?
The Aptima BV Assay specifically detects bacterial vaginosis (BV) by identifying microbial targets associated with the condition. In contrast, the Aptima CV/TV Assay is designed to diagnose candidal vaginitis (yeast infections caused by Candida species) and trichomoniasis (infections caused by *Trichomonas vaginalis*). Both assays use nucleic acid detection technology to identify these infections in symptomatic women, but they target distinct pathogens to aid in accurate diagnosis.
How are the Aptima BV and CV/TV assays supplied and what sample collection method is required for testing?
The Aptima BV Assay and Aptima CV/TV Assay are supplied as single-use diagnostic tools, meaning each test is intended for one-time use only. To perform the test, a vaginal swab sample must be collected using the Aptima multitest swab specimen collection kit, which is specifically designed for this purpose. The swab is then processed on the Panther® system for nucleic acid detection.
Are these assays intended for use in any specific clinical setting, and what precautions should be taken during handling?
These assays are intended exclusively for laboratory use and must be handled according to the manufacturer’s guidelines, which include standard laboratory safety protocols for infectious disease testing. Since they are single-use and designed for the Panther® system, they are not meant for point-of-care or clinical office testing without proper laboratory infrastructure.
What regulatory pathways have these assays undergone, and how does this impact their use in clinical practice?
The Aptima BV Assay and Aptima CV/TV Assay have received FDA 510(k) clearance through a Special Review process by the Microbiology (MI) Advisory Committee, confirming they are substantially equivalent to a predicate device. They also comply with the In Vitro Diagnostic Regulation (IVDR) in the EU. This regulatory clearance ensures their safety, effectiveness, and reliability for diagnosing bacterial vaginosis, candidal vaginitis, and trichomoniasis in clinical settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Aptima® BV and CV/TV Assay | Hologic Women's Health, Aptima® Vaginal Health Assay | Hologic, PDF Aptima® BV and CV/TV Assays - hologic.com, Aptima® CV/TV Assay | Vaginal Health Testing | Hologic® UK
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K243345 | Class II | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (3)
- FDA 510(k) K243345 24 fields · synced Sep 18, 2026
- FDA UDI 4b19f9e3-0377-4c96-b1c2-f6a87afa0467 37 fields · synced May 30, 2026
- EUDAMED d3072972-f156-43f4-b63c-8060d8d64a6e 61 fields · synced Jul 24, 2026