510(k) · Cleared
ClearedD3 Dfa Cytomegalovirus Immediate Early Antigen Identification Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Hybrids, Inc. · LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
Cleared on Jun 13, 2008 as substantially equivalent to K951821 (Light Diagnostics, 1996) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jun 13, 2008
- Review
- 50 days
- Class
- Class II
- Product code
- LIN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904036 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK904036 Bartels Cytomegalovirus Immed. Early AntigenBaxter Healthcare Corp · 1990
- This deviceK081164 D3 Dfa Cytomegalovirus Immediate Early Antigen Identification KitDiagnostic Hybrids, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904036 | Bartels Cytomegalovirus Immed. Early Antigen | Baxter Healthcare Corp | 1990 | — |
| 0 (this device) | K081164 | D3 Dfa Cytomegalovirus Immediate Early Antigen Identification Kit | Diagnostic Hybrids, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (2)
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 |
|---|---|---|---|
| * | K951821 | Cytomegalovirus Direct Immunofluorescence AssaySummary page 1…Cytomegalovirus Product Code - LIN Regulation - 21 CFR 866.3175, Cytomegalovirus serological reagents Legally marketed devices to which equivalence is claimed: 1. K951821, Light Diagnostics CMV Direct Immunofluorescence Assay (Millipore) Intended Use: Light Diagnostics Cytomegalovirus Direct I… | 1996 |
| * | K904036 | Bartels Cytomegalovirus Immed. Early AntigenSummary page 1…his product is not FDA approved for use in testing blood or plasma donors and is not intended for use in direct detection of CMV in clinical specimens. 2. K904036, Bartels Cytomegalovirus Immediate Early Antigen Indirect Fluorescent Antibody (Trinity Biotech PLC) Intended Use: Bart… | 1990 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All LIN devicesLIN Antisera, Conjugated Fluorescent, Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Diagnostic Hybrids, Inc. device, D 3 DFA Cytomegalovirus Immediate Early Antigen Identification Kit, is intended for use in the qualitative detection and identification of human Cytomegalovirus (CMV) immediate early antigen (IEA) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs).
This product is not intended for use in testing blood or plasma donors and is not intended for use in direct detection of cytomegalovirus in clinical specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081164: D3 Dfa Cytomegalovirus Immediate Early Antigen Identification Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081164
Report an extraction error
Are you the manufacturer?
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