Access anti-HBc Total

Q: What is the product code of K253687?

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.

FDA 510(k) K253687 · Beckman Coulter, Inc.

Substantially Equivalent

510(k) numberK253687

Submission

Device name: Access anti-HBc Total
Applicant: Beckman Coulter, Inc.
Chaska, MN, US
Received: November 21, 2025
Decision date: February 19, 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

510(k)	Device	Applicant	Decision
K260049	Elecsys Anti-HBc IgMSEI · Traditional	Roche Diagnostics	04/07/2026SE
K260046	Elecsys Anti-HBc IISEI · Traditional	Roche Diagnostics	04/07/2026SE
K254059	Access anti-HBc IgMSEI · Traditional	Beckman Coulter, Inc.	03/13/2026SE

More from Beckman Coulter, Inc.

510(k)	Device	Decision
K252169	Access BNP IINBC · Traditional	03/24/2026SE
K254059	Access anti-HBc IgMSEI · Traditional	03/13/2026SE
K251995	Access anti-HAV IgMLOL · Traditional	01/27/2026SE
K250588	Access Rubella IgGLFX · Traditional	11/17/2025SE
K252580	iQ200 SeriesLKM · Special	09/10/2025SE
K243846	Access anti-HAVLOL · Traditional	09/09/2025SE
K243804	MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional	08/20/2025SE
K250036	MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional	08/15/2025SE
K243483	Access hsTnIMMI · Traditional	08/01/2025SE
K250084	MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)LTT · Traditional	07/18/2025SE

Questions and answers

When was Access anti-HBc Total cleared by the FDA?

Access anti-HBc Total (K253687) received a 510(k) decision of Substantially Equivalent on February 19, 2026, 90 days after the submission was received.

What is the product code of K253687?

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.