510(k) · Cleared
ClearedHybrid Capture System CMV Dna Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digene Corp. · LJO Antigen, Iha, Cytomegalovirus
Cleared on Sep 29, 1998 as substantially equivalent to K921616 (Incstar Corp., 1992) after a 272-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Sep 29, 1998
- Review
- 272 days
- Class
- Class II
- Product code
- LJO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921616 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK921616 CMV-Vue (TM) CMV Antigen Detection KitIncstar Corp. · 1992
- This deviceK974901 Hybrid Capture System CMV Dna AssayDigene Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921616 | CMV-Vue (TM) CMV Antigen Detection Kit | Incstar Corp. | 1992 | — |
| 0 (this device) | K974901 | Hybrid Capture System CMV Dna Assay | Digene Corp. | 1998 | — |
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 LJO? 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 LJO device
- #1 K203612 Capture-CMVscore 1.3 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K921616 | CMV-Vue (TM) CMV Antigen Detection KitSummary page 2…Reagents IARAZ\REG_DOCS\CMV\RESPIINNEWSUM_4.DOC Predicate Devices CMYV Cell Culture (in use prior to May 28, 1976) INCSTAR Corporation’s CMV-vue™ Kit ( K921616) Device Description The Hybrid Capture® CMV DNA Assay is a qualitative in vitro diagnostic assay. Itis a nucleic acid, signal e… | 1992 |
| * | — | CMV Cell Culture (in use prior to May 28, 1976) Named without a submission number |
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 LJO devicesLJO Antigen, Iha, Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJO
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LJO
Too few LJO 510(k)s in any year since 2007 to give a median.
Recalls per year · LJO
No recall names LJO since 2007.
Adverse event reports per year · LJO
1in 2018
MAUDE reports naming product code LJO, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 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 Digene Hybrid Capture® CMV DNA Assay is a qualitative, in vitro, diagnostic assay intended for the detection of human cytomegalovirus (CMV) DNA in human peripheral white blood cells isolated from whole blood specimens collected in EDTA. It is indicated for use as an aid in diagnosing CMV infection in solid organ transplant, bone marrow transplant and HIV/AIDS patients. This assay has not been cleared by the FDA for blood/plasma donor screening.
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/K974901 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974901: Hybrid Capture System CMV Dna Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974901
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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