510(k) · Cleared
ClearedCell-Chex Auto
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck · JPK Mixture, Hematology Quality Control
Cleared on Jan 13, 2006 as substantially equivalent to K051706 (Streck, 2005) after a 42-day review. Its family tree reaches back 2 generations to 2000. 5 later devices descend from it.
- Decided
- Jan 13, 2006
- Review
- 42 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000076 (2000). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK000076 Cell-ChexStreck Laboratories, Inc. · 2000
- 1 generation backK051706 IQ Body Fluids ControlStreck · 2005
- This deviceK053362 Cell-Chex AutoStreck · 2006
- Descendant · cites it directly · 2 of its ownK120744 XN Check BFStreck · 2012
- Descendant · 2 generations on · 1 of its ownK141957 XN Check BFStreck · 2014
- Descendant · 3 generations on · 0 of its ownK160588 XN Check BFStreck · 2016
- Descendant · cites it directly · 0 of its ownK101578 R&D Systems Body Fluid-I Hematology ControlR&D Systems, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK090201 UA-Cellular for IQStreck · 2009
Most influential descendants
Showing 5 of 5 · See all- K120744XN Check BFStreck · 2012 · cites it directly2descendants
- K141957XN Check BFStreck · 2014 · 2 generations on1descendant
- K160588XN Check BFStreck · 2016 · 3 generations on0descendants
- K101578R&D Systems Body Fluid-I Hematology ControlR&D Systems, Inc. · 2011 · cites it directly0descendants
- K090201UA-Cellular for IQStreck · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000076 | Cell-Chex | Streck Laboratories, Inc. | 2000 | — |
| −1 | K051706 | IQ Body Fluids Control | Streck | 2005 | — |
| 0 (this device) | K053362 | Cell-Chex Auto | Streck | 2006 | — |
| +1 | K120744 | XN Check BF | Streck | 2012 | — |
| +2 | K141957 | XN Check BF | Streck | 2014 | — |
| +3 | K160588 | XN Check BF | Streck | 2016 | — |
| +1 | K101578 | R&D Systems Body Fluid-I Hematology Control | R&D Systems, Inc. | 2011 | — |
| +1 | K090201 | UA-Cellular for IQ | Streck | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 JPK? 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? (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 |
|---|---|---|---|
| * | K051706 | IQ Body Fluids ControlSummary page 1…Hematology Control for Body Fluids Classification Name: White and Red Blood Cell Control (864.8625) Predicate Device: iQ® Body Fluids Control (K051706) Manufactured by Streck Description: Cell-Chex Auto is a stabilized suspension of human red blood cells and simulated white bloo… | 2005 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K120744 (Streck, 2012) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JPK devicesJPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JPK
4in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JPK
296in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPK
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPK
2in 2023
MAUDE reports naming product code JPK, 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 | 5 | 44 | 1 | 14 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 5 | 187 | 0 | 0 |
| 2010 | 4 | 267 | 2 | 5 |
| 2011 | 1 | — | 3 | 56 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 4 | 296 | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 2 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Cell-Chex Auto is an assayed whole blood control for evaluating the accuracy and
precision of hematology instruments that measure blood cell counts in patient body fluid
samples.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053362: Cell-Chex Auto.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053362
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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