510(k) · Cleared
Recalled · 2010Seraquest Rubella Igg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Intl., Inc. · LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Cleared on Sep 4, 1996 after a 170-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 4, 1996
- Review
- 170 days
- Class
- Class II
- Product code
- LFX
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK961053 Seraquest Rubella IggQuest Intl., Inc. · 1996
- Descendant · cites it directly · 2 of its ownK091616 Bioplex 2200 MMRV IggBio-Rad Laboratories · 2010
- Descendant · 2 generations on · 0 of its ownK212769 DYNEX SmartPLEX MMRV IgG Assay KitDynex Technologies, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK111072 Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection…Bio-Rad Laboratories · 2011
Most influential descendants
Showing 3 of 3 · See all- K091616Bioplex 2200 MMRV IggBio-Rad Laboratories · 2010 · cites it directly2descendants
- K212769DYNEX SmartPLEX MMRV IgG Assay KitDynex Technologies, Inc. · 2023 · 2 generations on0descendants
- K111072Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200…Bio-Rad Laboratories · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961053 | Seraquest Rubella Igg | Quest Intl., Inc. | 1996 | — |
| +1 | K091616 | Bioplex 2200 MMRV Igg | Bio-Rad Laboratories | 2010 | — |
| +2 | K212769 | DYNEX SmartPLEX MMRV IgG Assay Kit | Dynex Technologies, Inc. | 2023 | — |
| +2 | K111072 | Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection System… | Bio-Rad Laboratories | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2023 | 1 | 0 |
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 LFX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LFX device
- #1 K250588 Access Rubella IgGscore 10.4 · 1 generation · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | — | Rubella IgG Clin-ELISA kit, INCSTAR Corporation Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091616 | Bioplex 2200 MMRV Igg | 2010 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2010 | Not classified | Z-2201-2011 | Software design | The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values. |
| Aug 20, 2008 | Not classified | Z-0908-2010 | Employee error | Elevated optical density (OD) values with the kit Negative Control. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091616 (Bio-Rad Laboratories, 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LFX devicesLFX Enzyme Linked Immunoabsorbent Assay, Rubella: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFX
354in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFX
12in 2025
MAUDE reports naming product code LFX, 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 | 1 | — | 2 | 5 |
| 2008 | 3 | 354 | 2 | 367 |
| 2009 | 0 | — | 3 | 19 |
| 2010 | 2 | — | 2 | 18 |
| 2011 | 1 | — | 1 | 89 |
| 2012 | 1 | — | 0 | 37 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 0 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 2 | 47 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 0 | — | 0 | 21 |
| 2021 | 0 | — | 1 | 13 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 2 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the qualitative and quantitative detection of human IgG antibodies to Rubella in human serum by enzyme immunoassay, to aid in the determination of infection with rubella virus. When used as a qualitative test, SeraQuest Rubella 1gG aids in the assessment of the patient's immunological response to rubella. For manual use, or for use with the HyPrep System Plus.
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/K961053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961053: Seraquest Rubella Igg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961053
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026