510(k) · Cleared
ClearedDiasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg Tri-Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Cleared on Nov 21, 2008 as substantially equivalent to K003412 (Bayer Corp., 2001) after a 354-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Nov 21, 2008
- Review
- 354 days
- Class
- Class II
- Product code
- LFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003412 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003412 Advia Centaur Rubella Igg AssayBayer Corp. · 2001
- This deviceK073390 Diasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg…DiaSorin, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003412 | Advia Centaur Rubella Igg Assay | Bayer Corp. | 2001 | — |
| 0 (this device) | K073390 | Diasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg Tri-Controls | DiaSorin, Inc. | 2008 | — |
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 |
|---|---|---|---|
| * | K003412 | Advia Centaur Rubella Igg AssaySummary page 1…nts and Controls Classification Names: Rubella Virus Serological Reagent Product Code: ,',}')() JUX PREDICATE DEVICE: Bayer Dlagnostics, ADVIA Centaur Rubella IgG assay, K003412 DEVICE DESCRIPTION: INTENDED USE; The LIAISON® Rubella IgG uses chemiluminescence immunoassay (CLIA) technology on the L!AISON®… | 2001 |
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.
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. 2008, this device’s year, is highlighted.
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?
The LIAISON® Rubella IgG uses chemiluminescence immunoussay (CLIA) technology on the LlAlSON® Analyzcr for the qualitative determination of IgG antibodies to rubella virus in human serum specimens. It is intended for use as an aid in the determination of immune status to rubella in individuals including pregnant women. The performance of this device has not been established for cord blood, neonatal samples, or for any matrices other than human serum.…
Read the full statement (108 words)
The LIAISON® Rubella IgG uses chemiluminescence immunoussay (CLIA) technology on the LlAlSON® Analyzcr for the qualitative determination of IgG antibodies to rubella virus in human serum specimens. It is intended for use as an aid in the determination of immune status to rubella in individuals including pregnant women.
The performance of this device has not been established for cord blood, neonatal samples, or for any matrices other than human serum. Likcwise, performance has not been established for population(s) of immunocompromised or immunosuppressed individuals.
The LIAISON® Rubella IgG Tri-Control kit is intended for use as assayed quality control samples to monitor the performance of the LIATSON® Rubella 1gG assay.
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/K073390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073390: Diasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg Tri-Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073390
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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