Elecsys Anti-HBc IgM

FDA 510(k) K260049 · Roche Diagnostics

Substantially Equivalent

510(k) numberK260049

Submission

Device name
Elecsys Anti-HBc IgM
Applicant
Roche Diagnostics
Indianapolis, IN, US
Received
January 7, 2026
Decision date
April 7, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
SEI – Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3173
Specialty
Microbiology

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…

Other 510(k)s with product code SEI

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K260046Elecsys Anti-HBc IISEI · Traditional Roche Diagnostics04/07/2026SE
K254059Access anti-HBc IgMSEI · Traditional Beckman Coulter, Inc.03/13/2026SE
K253687Access anti-HBc TotalSEI · Traditional Beckman Coulter, Inc.02/19/2026SE

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Questions and answers

When was Elecsys Anti-HBc IgM cleared by the FDA?

Elecsys Anti-HBc IgM (K260049) received a 510(k) decision of Substantially Equivalent on April 7, 2026, 90 days after the submission was received.

What is the product code of K260049?

The FDA product code is SEI – Qualitative And Quantitative Hepatitis B Virus Antibody Assays, a Class II (moderate risk) device regulated under 21 CFR 866.3173.