# K142758: ADVIA Centaur HAV total assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Dec 5, 2014 after 71 days
- Product code: LOL (Hepatitis A Test (Antibody And Igm Antibody))
- Device class: 2
- Regulation: 21 CFR 866.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P780012 (1979). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060678: Vitros Immunodiagnostic Products Anti-Hav Total Reagent Pack,Calibrator,Controls, Ortho-Clinical Diagnostics, Inc. (2006) Summary page 5.

## Indications for use
ADVIA Centaur and ADVIA Centaur XP systems: The ADVIA Centaur HAV Total (HAVT) assay is an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to hepatitis A virus (anti-HAV) in human neonatal, pediatric, and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP systems. This anti-HAV assay is indicated as an aid in the diagnosis of previous or ongoing hepatitis A viral infection or in the identification of HAV-susceptible individuals for vaccination. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. WARNING: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. United States federal law restricts this device to sale by or on the order of a physician. ADVIA Centaur CP system: The ADVIA Centaur HAV Total (HAVT) assay is an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to hepatitis A virus (anti-HAV) in human neonatal, pediatric, and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur CP system. This anti-HAV assay is indicated as an aid in the diagnosis of previous or ongoing hepatitis A viral infection or in the identification of HA V-susceptible individuals for vaccination. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. WARNING: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. United States federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K142758
Methodology: https://510kreport.com/methodology