# K991274: Mumps Igg Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Columbia Bioscience, Inc.
- Decided: Sep 3, 1999 after 143 days
- Product code: LJY (Enzyme Linked Immunoabsorbent Assay, Mumps Virus)
- Device class: 1
- Regulation: 21 CFR 866.3380
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Wampole Mumps IgG ELISA Kit: named in the summary without a submission number

## Recalls of this device
- Jan 5, 2018 · Class III · Z-2573-2018: Contains a gel-like contaminant that may affect product performance.
- Oct 20, 2014 · Class II · Z-1685-2016: A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
- Aug 8, 2005 · Not classified · Z-0557-06: Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a combined plate on the

## Indications for use
For the qualitative and semi-quantitative determination of IgG antibodies to Mumps virus in human serum of adults over eighteen years of age by indirect enzyme immunoassay as an aid in the diagnosis of Mumps infection. The evaluation of paired sera, to determine a significant increase in Mumps IgG antibody titer, can also aid in the diagnosis of acute infection by seroconversion determination through testing acute and convalescent sera. The test can be performed either manually or in conjunction with the MAGO® Plus Automated EIA processor. Performance characteristics have not been established on children

Source page: https://510kreport.com/device/K991274
Methodology: https://510kreport.com/methodology