510(k) · Cleared
ClearedCytomegalovirus Direct Immunofluorescence Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Diagnostics · LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
Cleared on Jun 7, 1996 after a 414-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jun 7, 1996
- Review
- 414 days
- Class
- Class II
- Product code
- LIN
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK951821 Cytomegalovirus Direct Immunofluorescence AssayLight Diagnostics · 1996
- Descendant · cites it directly · 0 of its ownK081164 D3 Dfa Cytomegalovirus Immediate Early Antigen Identification KitDiagnostic Hybrids, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K081164D3 Dfa Cytomegalovirus Immediate Early Antigen Identification KitDiagnostic Hybrids, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951821 | Cytomegalovirus Direct Immunofluorescence Assay | Light Diagnostics | 1996 | — |
| +1 | K081164 | D3 Dfa Cytomegalovirus Immediate Early Antigen Identification Kit | Diagnostic Hybrids, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
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 LIN? 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? (3)
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 |
|---|---|---|---|
| * | — | Light Diagnostics Cytomegalovirus Immunofluorescence Assay Named without a submission number | |
| * | — | Cytomegalovirus Pre-CPE Culture Identification Test Named without a submission number | |
| * | — | Syva MicroTrak CMV Culture Identification Test For pre-CPE and CPE applications Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081164 | D3 Dfa Cytomegalovirus Immediate Early Antigen Identification Kit | 2008 | 0 |
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?
- Of its descendants, K081164 (Diagnostic Hybrids, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LIN devicesLIN Antisera, Conjugated Fluorescent, Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIN
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · LIN
Too few LIN 510(k)s in any year since 2007 to give a median.
Recalls per year · LIN
No recall names LIN since 2007.
Adverse event reports per year · LIN
No MAUDE report names LIN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assay is intended for use in centrifugation enhanced shell vials in the qualitative detection and identification of immediate early antigen- of human CMV.
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/K951821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951821: Cytomegalovirus Direct Immunofluorescence Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951821
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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