# K093955: Anti-Hav Igm

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jun 22, 2010 after 181 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 P790019 (1980). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P790019: Havab-M Diagnostic Kit, Abbott Laboratories (1980) Summary page 1.

## Recalls of this device
- Oct 28, 2019 · Class II · Z-0669-2020: Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).
- Dec 17, 2018 · Class II · Z-0784-2019: Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result.

## Indications for use
The Roche Elecsys Anti-HAV IgM imnmunoassay is used for the in vitro qualitative detection of 1gM antibodies to hepatitis A virus (anti-HAV 1gM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection. The clectrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Elecsys PreciControl Anti-HAV IgM is used for quality control of the Elecsys Anti-HIAV 1gM immunoassay on the Elecsys and coals e immunoassay analyzers.

Source page: https://510kreport.com/device/K093955
Methodology: https://510kreport.com/methodology