510(k) · Cleared
Recalled · Class II · 2012Celltracks Autoprep System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Veridex, LLC · NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Cleared on Jan 20, 2012 after a 340-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jan 20, 2012
- Review
- 340 days
- Class
- Class II
- Product code
- NQI
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK110406 Celltracks Autoprep SystemVeridex, LLC · 2012
- Descendant · cites it directly · 0 of its ownK122821 Celltracks Autoprep SystemVeridex, LLC · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K122821Celltracks Autoprep SystemVeridex, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K110406 | Celltracks Autoprep System | Veridex, LLC | 2012 | — |
| +1 | K122821 | Celltracks Autoprep System | Veridex, LLC | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQI? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K122821 | Celltracks Autoprep System | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 28, 2012 | Class II | Z-1949-2013 | Software design | Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to… |
| Dec 28, 2012 | Class II | Z-1950-2013 | Software design | Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122821 (Veridex, LLC, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NQI devicesNQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NQI
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · NQI
Too few NQI 510(k)s in any year since 2007 to give a median.
Recalls per year · NQI
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQI
3in 2008
MAUDE reports naming product code NQI, 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 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 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 CellTracksO AutoPrepO System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer 1l0, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K110406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110406: Celltracks Autoprep System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110406
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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