Cleared Traditional

Access anti-HBc Total (C39432) Access anti-HBc Total Calibrator (C39433) Access anti-HBc Total QC (C39434)

K253687 · Beckman Coulter, Inc. · Microbiology
Feb 2026
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K253687 is an FDA 510(k) clearance for the Access anti-HBc Total (C39432) Access anti-HBc Total Calibrator (C39433) Access anti-HBc Total QC (C39434), a Qualitative And Quantitative Hepatitis B Virus Antibody Assays (Class II — Special Controls, product code SEI), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on February 19, 2026, 90 days after receiving the submission on November 21, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3173.

Submission Details

510(k) Number K253687 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2025
Decision Date February 19, 2026
Days to Decision 90 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.