510(k) · Cleared
Recalled · Class II · 2018Mumps Igg Elisa Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Columbia Bioscience, Inc. · LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Cleared on Sep 3, 1999 after a 143-day review. The FDA summary names its predicate without a number. It has been recalled 3 times.
- Decided
- Sep 3, 1999
- Review
- 143 days
- Class
- Class I
- Product code
- LJY
- Recalls
- 3
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Wampole Mumps IgG ELISA Kit Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 5, 2018 | Class III | Z-2573-2018 | Under Investigation by firm | Contains a gel-like contaminant that may affect product performance. |
| Oct 20, 2014 | Class II | Z-1685-2016 | Unknown/Undetermined by firm | 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 | Other | 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 ETI-Max 3000, with the ETI-Mumps IgG… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LJY devicesLJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJY
FDA has decided no LJY device since 2007.
Median 510(k) review, days · LJY
Too few LJY 510(k)s in any year since 2007 to give a median.
Recalls per year · LJY
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJY
1in 2018
MAUDE reports naming product code LJY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991274 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991274: Mumps Igg Elisa Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991274
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026