Aptima Herpes Simplex Viruses 1 & 2 Assay
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Aptima Herpes Simplex Viruses 1 & 2 Assay EUDAMEDAptima® FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Aptima Herpes Simplex Viruses 1 & 2 Assay EUDAMEDAptima® HSV 1 & 2 Assay, 100 test, box 2 of 2 (15°C to 30°C box). FDA UDI
- Model / Reference
- PRD-03568 EUDAMEDKIT, BOX 2, ROOM TEMP, AHSV, 100T, IVD FDA UDI
- Description
- Aptima® HSV 1 & 2 Assay, 100 test, box 2 of 2 (15°C to 30°C box). FDA UDI
Identifiers
- Catalog Number
- ASY-08089 FDA UDI
- Primary DI / UDI-DI
- 15420045507227 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455DIAGAPTHSV12S7 EUDAMED
- Direct Marketing DI
- 15420045507227 EUDAMED
- 510(k) Number
- FDA Product Code
- OQO FDA 510(k)FDA UDI
- EMDN Code
- W0105040311 HSV - NA REAGENTS EUDAMED
- GMDN Term
- Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 866.3305 FDA 510(k)
- Regulation Number
- 866.3305 FDA 510(k)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 Herpes Simplex Viruses 1 & 2 Assay is an in vitro diagnostic nucleic acid amplification test (NAAT) designed to detect and differentiate between Herpes Simplex Virus types 1 and 2. It employs real-time amplification technology to identify viral nucleic acid in clinical specimens, providing a sensitive and specific diagnostic tool for herpes infection.
This assay is intended for use in microbiology laboratories and is supplied as a single-use reagent kit. It requires compatibility with the Panther System for automated processing and is classified under Class II (Risk Class B) per IVDR and FDA regulations. Specimens are collected via swabs or other approved methods, and results are generated within hours, enabling rapid clinical decision-making.
Frequently asked questions
What types of clinical specimens can be tested using the Aptima Herpes Simplex Viruses 1 & 2 Assay, and how are they collected?
The Aptima Herpes Simplex Viruses 1 & 2 Assay is designed to detect Herpes Simplex Virus (HSV) types 1 and 2 in clinical specimens collected via swabs or other approved methods. While the exact specimen types aren’t detailed in the data, nucleic acid amplification tests (NAATs) like this one are commonly used with swabs from lesions, oral/genital swabs, or cerebrospinal fluid (CSF) in suspected cases of HSV infection. Always follow the manufacturer’s instructions for proper specimen collection and handling.
Is the Aptima Herpes Simplex Viruses 1 & 2 Assay intended for single-use or can it be reused across multiple tests?
The assay is explicitly supplied as a single-use reagent kit, meaning each kit is designed for one test run. This ensures consistency, sterility, and compliance with laboratory protocols for nucleic acid amplification tests. Reusing components could compromise accuracy or introduce contamination risks, so it must be treated as disposable.
How does the Aptima Herpes Simplex Viruses 1 & 2 Assay differ from other HSV diagnostic tests, and what makes it suitable for automated processing?
Unlike traditional culture methods or antibody tests, the Aptima assay uses real-time nucleic acid amplification technology (NAAT) to directly detect HSV-1 and HSV-2 nucleic acid in specimens, offering higher sensitivity and specificity. It is compatible only with the Panther System, an automated platform that streamlines workflows by handling specimen processing, amplification, and result generation—reducing manual labor and turnaround time to hours, ideal for high-volume microbiology labs.
What storage conditions are required for the Aptima Herpes Simplex Viruses 1 & 2 Assay kits, and how long can they remain stable?
While the exact storage details aren’t provided, most nucleic acid amplification test kits—including this one—require refrigeration (typically 2–8°C) to maintain stability. The manufacturer’s instructions (not included here) would specify shelf life post-receipt, but kits are generally valid for up to 24 months under proper conditions. Always verify with Hologic’s documentation for precise storage guidelines to avoid degradation of reagents.
What regulatory pathways does the Aptima Herpes Simplex Viruses 1 & 2 Assay follow, and how does its classification impact its use?
The assay was cleared via the FDA 510(k) pathway (traditional review, classified as Class II, Risk Class B) and complies with the In Vitro Diagnostic Regulation (IVDR) in Europe. Its Substantially Equivalent (SE) designation means it meets FDA standards for safety and effectiveness comparable to a predicate device. Clinically, this classification ensures it undergoes rigorous validation for accuracy and reliability in microbiology labs, though actual indications (e.g., diagnostic use for HSV) are determined by clinical judgment, not regulatory filings.
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® Herpes Simplex 1 & 2 assay | Hologic, Aptima Herpes Simplex Viruses 1 & 2 Assay - Hologic, Aptima® HSV 1 & 2 Assay | Herpes Simplex Virus | Hologic® UK, PDF Aptima Herpes Simplex Viruses 1 & 2 Assay - stage.hologic.com
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 | K162673 | Class II | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (3)
- FDA 510(k) K162673 24 fields · synced Sep 18, 2026
- FDA UDI ac508cc6-5433-4e6f-8422-59b4a4064832 37 fields · synced May 30, 2026
- EUDAMED ef8e7c5e-ac24-4320-b51e-ac23371ee346 61 fields · synced Jul 11, 2026