510(k) · Cleared
ClearedImmulite 2000 CMV Igg, Model L2KCV2, L2KCV6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Cleared on Dec 16, 1999 as substantially equivalent to K950672 (Diagnostic Products Corp., 1996) after a 24-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Dec 16, 1999
- Review
- 24 days
- Class
- Class II
- Product code
- LFZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950672 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK950672 Immulite CMV IggDiagnostic Products Corp. · 1996
- This deviceK993952 Immulite 2000 CMV Igg, Model L2KCV2, L2KCV6Diagnostic Products Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950672 | Immulite CMV Igg | Diagnostic Products Corp. | 1996 | — |
| 0 (this device) | K993952 | Immulite 2000 CMV Igg, Model L2KCV2, L2KCV6 | Diagnostic Products Corp. | 1999 | — |
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 LFZ? 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 LFZ device
- #1 K220911 Elecsys CMV IgGscore 4.8 · 3 generations · 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 |
|---|---|---|---|
| * | K950672 | Immulite CMV IggSummary page 1…s II device, LFZ (21CFR 866.3175) Diagnostic Products Corporation 5700 West 96" Street Los Angeles, CA 90045-5597 DPC Registration number is 2017183 IMMULITE® CMV IgG (K950672) IMMULITE® 2000 CMV IgG is a clinical use device intended for use with the IMMULITE® 2000 Automated Immunoassay Analyzer === Pa… | 1996 |
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 LFZ devicesLFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFZ
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LFZ
Too few LFZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LFZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFZ
53in 2025
MAUDE reports naming product code LFZ, 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 | 7 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 1 | 14 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 2 | — | 0 | 13 |
| 2018 | 1 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 2 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 1 | 53 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro use with the IMMULITE® 2000 Automated Analyzer - for the qualitative detection of IgG antibodies to cytomegalovirus (CMV) in human serum as an aid in the determination of serological status to CMV. This kit is not cleared for use in testing (i.e. screening) blood or plasma donors.
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/K993952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993952: Immulite 2000 CMV Igg, Model L2KCV2, L2KCV6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993952
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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