# K222850: HAVAb IgG II

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 10, 2023 after 323 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 K063329 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113704: Architect Havab-G, Abbott Laboratories (2012) Summary page 5.

## Indications for use
The HAVAb IgG II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgG antibody to hepatitis A virus (IgG anti-HAV) in human adult and pediatric (4 through 21 years) serum (collected in serum and serum separator tubes) and plasma (collected in sodium heparin, lithium heparin, lithium heparin separator, dipotassium EDTA, and tripotassium EDTA tubes) from patients with signs and symptoms or at risk for hepatitis A on the Alinity i system. The HAVAb IgG II assay is used to determine the immune status of individuals to hepatitis A virus (HAV) infection. Warning: This assay has not been cleared for use in screening blood, plasma, or tissue donors. This assay cannot be used for the diagnosis of acute HAV infection. Assay performance characteristics have not been established when the HAVAb IgG II assay is used in conjunction with other hepatitis assays.

Source page: https://510kreport.com/device/K222850
Methodology: https://510kreport.com/methodology