510(k) Report

510(k) · Cleared

Cleared

Celltracks Autoprep System Model:9541

K100684510(k) TraditionalCleared Aug 26, 2010169-day reviewClass I21 CFR 864.5240

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Veridex, LLC · GKH Apparatus, Automated Blood Cell Diluting

Cleared on Aug 26, 2010 as substantially equivalent to K040077 (Immunicon Corp., 2004) after a 169-day review. Its family tree reaches back 1 generation to 2004.

Decided
Aug 26, 2010
Review
169 days
Class
Class I
Product code
GKH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K040077 (2004). No later device cites it as a predicate yet.

K040077 · Immunicon Celltracks Autoprep System · Immunicon Corp. · 2004 · recalled2000200220042006200820102012
K040077 · Immunicon Celltracks Autoprep System · Immunicon Corp. · 2004 · recalled0
  1. Root · 1 generation backK040077 Immunicon Celltracks Autoprep SystemImmunicon Corp. · 2004 · Recalled
  2. This deviceK100684 Celltracks Autoprep System Model:9541Veridex, LLC · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K040077Immunicon Celltracks Autoprep SystemImmunicon Corp.20042
0 (this device)K100684Celltracks Autoprep System Model:9541Veridex, LLC2010—
FIG. 1 — Lineage of K100684, 2004–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 GKH? 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K040077Immunicon Celltracks Autoprep System
Summary page 1
…(21 CFR 864.5240, Product Code GKH) 4. Predicate device The predicate device isthe CellTracksO AutoPrepO System (K040077, March 12, 2004) 510(k) Summary, Continued 5. Device Description The CellTracksO AutoPrepO Syst…
Immunicon Corp.20042

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 a recall.

How does its category compare?

All GKH devices

GKH Apparatus, Automated Blood Cell Diluting: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · GKH

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKH

Too few GKH 510(k)s in any year since 2007 to give a median.

Recalls per year · GKH

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GKH

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2025

MAUDE reports naming product code GKH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—12
20101—10
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The CellTracks® AutoPrep® 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 II®, CellSpotter® System, 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 summary.

More from Veridex, LLC

12 FDA decisions under this applicant name. See the company

  • K130794Celltracks Analyzer II SystemVeridex, LLC · 20131 recall
  • K122821Celltracks Autoprep SystemVeridex, LLC · 20122 recalls
  • K110406Celltracks Autoprep SystemVeridex, LLC · 20122 recalls
  • K113181Celltracks Analyer IIVeridex, LLC · 20111 recall
  • K103502Cellsearch Circulating Tumor Cell Kit Model 7900001Veridex, LLC · 20103 recalls

Recent decisions in GKH

The GKH category page

  • K040077Immunicon Celltracks Autoprep SystemImmunicon Corp. · 20042 recalls
  • K022512Cellprep Sample Preparation System, Model 9518Immunicon Corp. · 2002
  • K021150Coulter CellprepBeckman Coulter, Inc. · 2002
  • K935953Coulter Multi Q PrepCoulter Corp. · 1994
  • K923530Coulter Multi-Q-PrepCoulter Electronics, Inc. · 1992

https://510kreport.com/device/K100684 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100684: Celltracks Autoprep System Model:9541.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100684

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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