Cleared Traditional

Access anti-HBc IgM

K254059 · Beckman Coulter, Inc. · Microbiology
Mar 2026
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K254059 is an FDA 510(k) clearance for the Access anti-HBc IgM, 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 review panel. Regulated under 21 CFR 866.3173.

Submission Details

510(k) Number K254059 FDA.gov
FDA Decision Cleared 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

Device Classification

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.