# K063329: Abbott Architect Havab-M

- Pathway: 510(k) (Abbreviated)
- Applicant: Abbott Laboratories
- Decided: Apr 16, 2007 after 164 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- P790012: ABBOTT AxSYM® HAVAB®-M 2.0 assay. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K251995: Access anti-HAV IgM (2026), 1 descendant of its own
- K113704: Architect Havab-G (2012), 1 descendant of its own
- K260048: Elecsys Anti-HAV IgM (2026), 0 descendants of its own
- K222850: HAVAb IgG II (2023), 0 descendants of its own

## Recalls of this device
- Apr 20, 2011 · Not classified · Z-2413-2011: The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results.
- Dec 30, 2009 · Not classified · Z-1596-2010: There is a potential to generate a false grayzone or reactive HAVAB-M result when the ARCHITECT AUSAB assay precedes the ARCHITECT HAVAB-M assay.

## Indications for use
The ARCHITECT HAVAB-M assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum. A test for IgM anti-HAV is indicated for testing of specimens from individuals who have signs and symptoms consistent with acute hepatitis. Test results are used in conjunction with other laboratory results and clinical information as an aid in the diagnosis of acute or recent hepatitis A viral infection. Warning: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT HAVAB-M for use in screening blood, plasma, or tissue donors has not been established. Assay performance characteristics have not been established when the ARCHITECT HAVAB-M assay is used in conjunction with other manufacturers' assays for specific hepatitis markers. Users are responsible for establishing their own performance characteristics. ARCHITECT HAVAB-M Calibrator: The ARCHITECT HAVAB-M Calibrator is used to calibrate the ARCHITECT i System when the system is used for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) using the ARCHITECT HAVAB-M Reagent Kit. The performance of the ARCHITECT HAVAB-M Calibrator has not been established with any other IgM anti-HAV assays. ARCHITECT HAVAB-M Controls: The ARCHITECT HAVAB-M Controls are used for monitoring the performance of the ARCHITECT i System when used for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) using the ARCHITECT HAVAB-M Reagent Kit. The performance of the ARCHITECT HAVAB-M Controls has not been established with any other IgM anti-HAV assays.

Source page: https://510kreport.com/device/K063329
Methodology: https://510kreport.com/methodology