# P890014: HA-Igmk and Eti-HA-Igmk

- Pathway: PMA
- Applicant: DiaSorin, Inc.
- Decided: Jul 24, 1990 after 501 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.
7 later devices descend from it; 3 cite it directly.
0 of 8 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
- K082050: Liaison Hav Igm Assay, Liaison Control Hav Igm (2008), 3 descendants of its own
- K103529: Liaison XL Analyzer Model 10050 (2011), 2 descendants of its own
- K141116: Liaison XL Analyzer (2014), 1 descendant of its own
- K063319: Monolisa Anti-Hav Igm Eia (2007), 1 descendant of its own
- K260770: LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (2026), 0 descendants of its own

## Recalls of this device
- Apr 8, 2005 · Not classified · Z-0776-05: The package insert for Hepatitis A Virus IgM antibody kit (ETI-IgMK Plus, catalog P001925), may inadvertently contain pages 5 through 12 from the instructions for Hepatitus A virus Total antibody test

Source page: https://510kreport.com/device/P890014
Methodology: https://510kreport.com/methodology