# P790019: Havab-M Diagnostic Kit

- Pathway: PMA
- Applicant: Abbott Laboratories
- Decided: Jun 10, 1980 after 288 days
- Product code: LOL (Hepatitis A Test (Antibody And Igm Antibody))
- Device class: 2
- Regulation: 21 CFR 866.3310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K060770: Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack, Calibrator, and Controls (2006), 1 descendant of its own
- K161964: ADVIA Centaur HAV IgM Assay (2016), 0 descendants of its own
- K093955: Anti-Hav Igm (2010), 0 descendants of its own

## Recalls of this device
- Apr 23, 2007 · Not classified · Z-1036-2007: Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instru

Source page: https://510kreport.com/device/P790019
Methodology: https://510kreport.com/methodology