510(k) · Cleared
Recalled · Class II · 2016Immulite Rubella Igm,LKRM1, LKRM2, Immulite 2000 Rubella Igm, Model L2KRM2, L2KRM6
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 Jan 10, 2002 as substantially equivalent to K885300 (Mercia Diagnostics, Ltd., 1989) after a 192-day review. Its family tree reaches back 1 generation to 1989. It has been recalled 2 times.
- Decided
- Jan 10, 2002
- Review
- 192 days
- Class
- Class II
- Product code
- LFX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K885300 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK885300 Captia (R) Rubella-MMercia Diagnostics, Ltd. · 1989
- This deviceK012077 Immulite Rubella Igm,LKRM1, LKRM2, Immulite 2000 Rubella Igm, Model…Diagnostic Products Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885300 | Captia (R) Rubella-M | Mercia Diagnostics, Ltd. | 1989 | — |
| 0 (this device) | K012077 | Immulite Rubella Igm,LKRM1, LKRM2, Immulite 2000 Rubella Igm, Model L2KRM2… | Diagnostic Products Corp. | 2002 | — |
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 |
|---|---|---|---|
| * | K885300 | Captia (R) Rubella-MSummary page 1…, CA 90045 (The Quality System of Diagnostic Products Corporation is registered to ISO 9001:1994) DPC’s Registration Number 2017183 Trinity Biotech™ CAPTIA Rubella-M (K885300) Description of Devices: IMMULITE Rubella IgM and IMMULITE 2000 Rubella IgM are clinical devices for use with the… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2016 | Class II | Z-0081-2017 | Under Investigation by firm | Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi… |
| Aug 24, 2016 | Class II | Z-0082-2017 | Under Investigation by firm | Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi… |
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.
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 IgM — For in vitro diagnostic use with the IMMULITE Analyzer - for the qualitative detection of IgM antibodies to rubella virus in human serum or plasma (EDTA or heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
IMMULITE 2000%® Rubella IgM — For in vitro diagnostic use with the IMMULITE 2000 Analyzer — for the qualitative detection of IgM antibodies to rubella virus in human serum or plasma (EDTA or heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
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/K012077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012077: Immulite Rubella Igm,LKRM1, LKRM2, Immulite 2000 Rubella Igm, Model L2KRM2, L2KRM6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012077
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026