FDA product code · Microbiology
Hepatitis Viral B Dna Detection
5 FDA decisions since 2008. 7 recalls name this code, 0 of them Class I.
Nucleic acid assay for detection of Hepatitis B Virus (HBV) DNA is an in vitro nucleic acid assay for detection and quantitation of HBV DNA in human serum or plasma. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MKT at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · MKT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKT
Too few MKT 510(k)s in any year since 2007 to give a median.
Recalls per year · MKT
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MKT
2in 2025
MAUDE reports naming product code MKT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 2 | — | 2 | 5 |
| 2011 | 6 | — | 0 | 11 |
| 2012 | 9 | — | 0 | 8 |
| 2013 | 17 | — | 0 | 3 |
| 2014 | 7 | — | 0 | 2 |
| 2015 | 8 | — | 0 | 0 |
| 2016 | 16 | — | 1 | 0 |
| 2017 | 13 | — | 0 | 1 |
| 2018 | 29 | — | 0 | 1 |
| 2019 | 28 | — | 0 | 1 |
| 2020 | 14 | — | 0 | 0 |
| 2021 | 9 | — | 0 | 0 |
| 2022 | 9 | — | 2 | 2 |
| 2023 | 16 | — | 0 | 2 |
| 2024 | 18 | — | 0 | 2 |
| 2025 | 10 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
Planning a device in MKT? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report