510(k) · Cleared
ClearedAptima CMV Quant Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · PAB Cytomegalovirus (Cmv) Dna Quantitative Assay
Cleared on Jan 17, 2025 as substantially equivalent to P210029 (Hologic, Inc., 2022) after a 28-day review. Its family tree reaches back 1 generation to 2022.
- Decided
- Jan 17, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- PAB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P210029 (2022). No later device cites it as a predicate yet.
- Root · 1 generation backP210029 Aptima CMV Quant AssayHologic, Inc. · 2022
- This deviceK243935 Aptima CMV Quant AssayHologic, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P210029 | Aptima CMV Quant Assay | Hologic, Inc. | 2022 | — |
| 0 (this device) | K243935 | Aptima CMV Quant Assay | Hologic, Inc. | 2025 | — |
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 PAB? 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 PAB device
- #1 K252481 cobas CMVscore 10.3 · 1 generation · 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 |
|---|---|---|---|
| * | P210029 | Aptima CMV Quant AssaySummary page 5…Regulatory Class: Class II Product Code: PAB III. PREDICATE DEVICE The predicate device is the Aptima CMV Quant Assay (P210029; approved May 9, 2022), marketed as a 100-test kit configuration. 510(k) Summary Special 510(k) Submission Co… | 2022 |
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 PAB devicesPAB Cytomegalovirus (Cmv) Dna Quantitative Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PAB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PAB
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PAB
No recall names PAB since 2007.
Adverse event reports per year · PAB
4in 2025
MAUDE reports naming product code PAB, 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 | 0 |
| 2012 | 3 | — | 0 | 0 |
| 2013 | 10 | — | 0 | 0 |
| 2014 | 4 | — | 0 | 1 |
| 2015 | 8 | — | 0 | 2 |
| 2016 | 7 | — | 0 | 1 |
| 2017 | 13 | — | 0 | 1 |
| 2018 | 24 | — | 0 | 2 |
| 2019 | 21 | — | 0 | 1 |
| 2020 | 8 | — | 0 | 0 |
| 2021 | 4 | — | 0 | 0 |
| 2022 | 9 | — | 0 | 1 |
| 2023 | 14 | — | 0 | 3 |
| 2024 | 16 | — | 0 | 2 |
| 2025 | 3 | 88 | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Aptima® CMV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus (CMV) DNA in human EDTA plasma on the fully automated Panther® system. The Aptima CMV Quant Assay is intended for use to aid in the management of solid-organ transplant patients and hematopoietic stem cell transplant patients. In patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to…
Read the full statement (116 words)
The Aptima® CMV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus (CMV) DNA in human EDTA plasma on the fully automated Panther® system.
The Aptima CMV Quant Assay is intended for use to aid in the management of solid-organ transplant patients and hematopoietic stem cell transplant patients. In patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to treatment. The results from Aptima CMV Quant assay must be interpreted within the context of all relevant clinical and laboratory findings.
The Aptima CMV Quant Assay is not intended for use as a screening assay for the presence of CMV in blood or blood products.
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/K243935 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243935: Aptima CMV Quant Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243935
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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