510(k) · Cleared
ClearedSeraquest Mumps Igg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Intl., Inc. · LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Cleared on Apr 23, 1998 after a 106-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 23, 1998
- Review
- 106 days
- Class
- Class I
- Product code
- LJY
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
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 in vitro diagnostic use only.
For the qualitative and semi-quantitative detection of IgG antibodies to mumps virus in human serum by enzyme immunoassay.
Individual specimens may be used for the determination of immune status. Paired (acute / convalescent) sera, may be used to demonstrate seroconversion or significant rises in antibody level, as an aid in the dlagnoms of primary infection.
For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980059 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980059: Seraquest Mumps Igg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980059
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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