510(k) · Cleared
ClearedImmulite Rubella Quantitative Igg, Catalog # LKRBQ1 (100 Tests), LKRBQ5 (500 Tests)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Cleared on Dec 11, 1998 as substantially equivalent to K885297 (Abbott Laboratories, 1989) after a 179-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Dec 11, 1998
- Review
- 179 days
- Class
- Class II
- Product code
- LFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K885297 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK885297 Imx Rubella Igg, Microparticle Enzyme ImmunoassayAbbott Laboratories · 1989
- This deviceK982078 Immulite Rubella Quantitative Igg, Catalog # LKRBQ1 (100 Tests)…Diagnostic Products Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885297 | Imx Rubella Igg, Microparticle Enzyme Immunoassay | Abbott Laboratories | 1989 | — |
| 0 (this device) | K982078 | Immulite Rubella Quantitative Igg, Catalog # LKRBQ1 (100 Tests), LKRBQ5 (500… | Diagnostic Products Corp. | 1998 | — |
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 |
|---|---|---|---|
| * | K885297 | Imx Rubella Igg, Microparticle Enzyme ImmunoassaySummary page 1….3510) Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597 DPC's Registration # 1s 2017183 Abbott Laboratories' IMx® Rubella IgG (K885297) Description of Device: IMMULITE Rubella Quantitative IgG is a clinical device for use with the IMMULITE Automate… | 1989 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K885297.
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?
IMMULITE Rubella Quantitative is a solid-phase chemiluminescent enzyme immunoassay for use on the IMMULITE Automated Analyzer and designed for the quantitative measurement of IgG antibodies to rubella virus in human serum. It is intended strictly for in vitro diagnostic use as an aid in the determination of immune status to rubella, particularly for women of childbearing age. The performance characteristics of the assay have not been established for use with neonate and cord blood specimens
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/K982078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982078: Immulite Rubella Quantitative Igg, Catalog # LKRBQ1 (100 Tests), LKRBQ5 (500 Tests).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982078
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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