K254059 is an FDA 510(k) clearance for the Access anti-HBc IgM. This device is classified as a Qualitative And Quantitative Hepatitis B Virus Antibody Assays (Class II - Special Controls, product code SEI).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on March 13, 2026, 86 days after receiving the submission on December 17, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3173. In Vitro Diagnostic Devices Intended For Use In The Detection Of Antibodies To Hbv. These Devices Are Intended To Aid In The Diagnosis Of Hbv Infection In Persons With Signs And Symptoms Of Hepatitis And In Persons At Risk For Hbv Infection. Anti-hbs Assay Results May Be Used As An Aid In The Determination Of Susceptibility To Hbv Infection In Individuals Prior To Or Following Hbv Vaccination Or When Vaccination Status Is Unknown..
| 510(k) Number | K254059 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2025 |
| Decision Date | March 13, 2026 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | SEI — Qualitative And Quantitative Hepatitis B Virus Antibody Assays |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3173 |
| Definition | In Vitro Diagnostic Devices Intended For Use In The Detection Of Antibodies To Hbv. These Devices Are Intended To Aid In The Diagnosis Of Hbv Infection In Persons With Signs And Symptoms Of Hepatitis And In Persons At Risk For Hbv Infection. Anti-hbs Assay Results May Be Used As An Aid In The Determination Of Susceptibility To Hbv Infection In Individuals Prior To Or Following Hbv Vaccination Or When Vaccination Status Is Unknown. |