Aptima HBV Quant Assay
PMA P170025
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP170025 | Date23 Jan 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic name
- Hepatitis Viral B DNA Detection
- PMA number
- FDA product code
- MKT
- Device class
- Class II
- Regulation
- 21 CFR Part 866.3174
- Advisory committee
- Microbiology
- FDA decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The Aptima HBV Quant Assay is an in vitro nucleic acid amplification test classified under Microbiology (Device Type: Hepatitis Viral B DNA Detection). It quantifies hepatitis B virus (HBV) DNA in human plasma and serum samples, supporting clinical management of chronic HBV infections during antiviral therapy. The assay detects HBV genotypes A, B, C, D, E, F, G, and H and is validated for use on the fully automated Panther® system.
Specimens may be collected in EDTA, ACD solution, plasma preparation tubes (PPTs), serum tubes, or serum separator tubes (SSTs). The test is performed on the Panther® system for automated sample processing, amplification, and quantitation. It is not intended for screening blood products or diagnosing HBV infection but is authorized for measuring HBV DNA levels at baseline and during treatment with tenofovir disoproxil fumarate or entecavir. The assay holds FDA PMA approval (P170025) and is classified under device class 2 (regulation number 866.3174).
Other devices from Hologic, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of patient samples can be tested with the Aptima HBV Quant Assay, and how are they collected?
The Aptima HBV Quant Assay is designed to quantify hepatitis B virus (HBV) DNA in human plasma and serum samples. Specimens can be collected in EDTA tubes, ACD solution tubes, plasma preparation tubes (PPTs), serum tubes, or serum separator tubes (SSTs). This flexibility ensures compatibility with common blood collection methods while maintaining assay validity.
Is the Aptima HBV Quant Assay intended for use in screening blood products or diagnosing HBV infection?
No, the Aptima HBV Quant Assay is explicitly not intended for screening blood products or diagnosing HBV infection. Instead, it is authorized for measuring HBV DNA levels in patients with chronic HBV infections to aid in clinical management during antiviral therapy with drugs like tenofovir disoproxil fumarate or entecavir. Its purpose is limited to quantifying viral load for treatment monitoring, not initial diagnosis.
How does the Aptima HBV Quant Assay differ from other HBV tests in terms of its detection capabilities?
Unlike some HBV tests, the Aptima HBV Quant Assay is specifically validated to detect and quantify all eight HBV genotypes (A, B, C, D, E, F, G, and H). This broad genotype coverage ensures accurate viral load measurement across diverse patient populations, supporting more precise treatment decisions for chronic HBV management.
What system is required to run the Aptima HBV Quant Assay, and is it fully automated?
The Aptima HBV Quant Assay is designed exclusively for use on the fully automated Panther® system by Hologic. This system handles all steps—sample processing, nucleic acid amplification, and quantitation—reducing manual intervention and improving workflow efficiency in clinical laboratories.
Can the Aptima HBV Quant Assay be used to determine the clinical stage of HBV infection?
No, the assay’s performance for determining the clinical stage of HBV infection has not been established. It is only authorized for quantifying HBV DNA levels at baseline and during treatment with specific antiviral drugs (e.g., tenofovir or entecavir) to assess viral response. Clinical interpretation must always consider all relevant patient data, not just assay results.