510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260049Substantially Equivalent

Elecsys Anti-HBc IgM

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260049 is the FDA 510(k) clearance record for Elecsys Anti-HBc IgM, a class II device, cleared for Roche Diagnostics on under FDA product code SEI (Qualitative And Quantitative Hepatitis B Virus Antibody Assays). FDA's definition for product code SEI reads: "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...". FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K260049.

Clearance record

Decision date
Received
(90 days to decision)
Product code
SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Regulation
21 CFR 866.3173
Device class
Class II
Review panel
Microbiology
Applicant
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SEI

Trailing 12 months
4 clearances under product code SEI in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code SEI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20262
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260