510(k) K254059
K254059 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access anti-HBc IgM". The FDA issued a decision of Substantially Equivalent on March 13, 2026. The device falls under product code SEI (Qualitative And Quantitative Hepatitis B Virus Antibody Assays), a Class II device regulated under 21 CFR 866.3173. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2026
- Date Received
- December 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Qualitative And Quantitative Hepatitis B Virus Antibody Assays
- Device Class
- Class II
- Regulation Number
- 866.3173
- Review Panel
- MI
- Submission Type
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.