# K113704: Architect Havab-G

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 28, 2012 after 195 days
- Product code: LOL (Hepatitis A Test (Antibody And Igm Antibody))
- Device class: 2
- Regulation: 21 CFR 866.3310
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K063329 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063329: Abbott Architect Havab-M, Abbott Laboratories (2007) Summary page 2.

## Most influential descendants
- K222850: HAVAb IgG II (2023), 0 descendants of its own

## Recalls of this device
- Mar 9, 2020 · Class II · Z-1728-2020: An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
- Nov 7, 2019 · Class II · Z-0574-2020: Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confirmed that the increase in the calibrator RLU value

## Indications for use
ARCHITECT HAVAB-G. The ARCHITECT HAVAB-G assay is a chemilumninescent microparticle immunoassay (CMIA) for the qualitative detection of IgG antibody to hepatitis A virus (IgG anti-HAV) in human adult and pediatric serum from patients with signs and symptoms or at risk for hepatitis. The ARCHITECT HAVAB-G assay is used to determine the inmnune status of individuals to hepatitis A virus infection. Warning: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. This assay cannot be used for the diagnosis of acute HAV infection. Assay performance characteristics have not been established when the ARCHITECT HAVAB-G assay is used in conjunction with other hepatitis assays. ARCHITECT HAVAB-G Calibrator: The ARCHITECT HAVAB-G Calibrator is for the calibration of the ARCHITECT iSystem, when used for the qualitative detection of IgO antibody to hepatitis A virus (IgG anti-HAy) in human adult and pediatric serum from patients with signs and symptoms or at risk for hepatitis. The ARCHITECT HAVAB-G assay is used to determine the immune status of individuals to hepatitis A virus infection, using the ARCHITECT HAVAB-G Reagent Kit. The performance of the ARCHITECT HAVAB-G Calibrator has not been established with any other IgG anti-HAV assays. HAVAB-G Controls: The ARCHITECT HAVAB-G Controls are used for monitoring the performance of the ARCHITECT i System, when used for the qualitative detection of JgG antibody to hepatitis A virus (IgG anti-HAy) in human adult and pediatric serum from patients with signs and symptoms or at risk for hepatitis. The ARCHITECT HAVAB-G assay is used to determine the immune status of individuals to hepatitis A virus infection, using the ARCHITECT HAVAB-G Reagent Kit. The performance of the ARCHITECT HAVAB-G Controls have not been established with any other IgG anti-HAV assays

Source page: https://510kreport.com/device/K113704
Methodology: https://510kreport.com/methodology