510(k) · Cleared
Recalled · Class II · 2016Immulite 2000 CMV Igm, Immulite CMV Igm Controls, and Immulite 200 CMV Igm Adjustor Model L2KCM2, L2KCM6, LCMC1, LCMC2,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · LKQ Antibody Igm,If, Cytomegalovirus Virus
Cleared on May 13, 2010 as substantially equivalent to K933549 (Biomerieux Vitek, Inc., 1994) after an 86-day review. Its family tree reaches back 1 generation to 1994. It has been recalled 2 times.
- Decided
- May 13, 2010
- Review
- 86 days
- Class
- Class II
- Product code
- LKQ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933549 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK933549 Vidas CMV Igm AssayBiomerieux Vitek, Inc. · 1994 · Recalled
- This deviceK100433 Immulite 2000 CMV Igm, Immulite CMV Igm Controls, and Immulite 200…Siemens Healthcare Diagnostics · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933549 | Vidas CMV Igm Assay | Biomerieux Vitek, Inc. | 1994 | 2 |
| 0 (this device) | K100433 | Immulite 2000 CMV Igm, Immulite CMV Igm Controls, and Immulite 200 CMV Igm… | Siemens Healthcare Diagnostics | 2010 | — |
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 LKQ? 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? (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 |
|---|---|---|---|
| * | K933549 | Vidas CMV Igm AssaySummary page 1…2010 Device Trade Name: IMMULITE® 2000 CMV IgM Common Name: Cytomnegalovirus serological reagents 21 CFR 866.3175 Substantial K933549 Equivalence: VIDAS® CMV 1gM assay Device Description: IMMULITE 2000 CMV 1gM is a solid-phase, enzyme… | 1994 |
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 30, 2016 | Class II | Z-0319-2017 | Under Investigation by firm | Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above. |
| Aug 30, 2016 | Class II | Z-0320-2017 | Under Investigation by firm | Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K933549.
How does its category compare?
All LKQ devicesLKQ Antibody Igm,If, Cytomegalovirus Virus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LKQ
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · LKQ
Too few LKQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LKQ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKQ
17in 2022
MAUDE reports naming product code LKQ, 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 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 3 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 2 | 29 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 68 |
| 2022 | 0 | — | 1 | 17 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
IMMULITE® 2000 CMV IgM is for in vitro diagnostic use with IMMULITEO 2000 Systems analyzers for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the diagnosis of current and recent CMV infection in individuals with signs and symptoms of CMV infection or clinical suspicion of CMV infection. This assay is not FDA cleared or approved for use in testing (screening) blood or…
Read the full statement (129 words)
IMMULITE® 2000 CMV IgM is for in vitro diagnostic use with IMMULITEO 2000 Systems analyzers for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the diagnosis of current and recent CMV infection in individuals with signs and symptoms of CMV infection or clinical suspicion of CMV infection. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors, neonatal screening, or for use at point-of-care facilities.
Performance characteristics for this assay have not been established in immunocompromised, immunosuppressed or organ transplant individuals.
CMV IgM Controls are assayed, bi-level controls intended for use with the IMMULITE 2000 CMV igM assay. They are intended as an aid in monitoring day-to-day assay performance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100433: Immulite 2000 CMV Igm, Immulite CMV Igm Controls, and Immulite 200 CMV Igm Adjustor Model L2KCM2, L2KCM6, LCMC1, LCMC2,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100433
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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