510(k) · Cleared
ClearedImmuno-Trol Control Cells
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coulter Corp. · JPK Mixture, Hematology Quality Control
Cleared on Mar 16, 1999 as substantially equivalent to K894651 (Coulter Corp., 1989) after a 112-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- Mar 16, 1999
- Review
- 112 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894651 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK894651 Coulter Positive Control CellsCoulter Corp. · 1989
- This deviceK984216 Immuno-Trol Control CellsCoulter Corp. · 1999
- Descendant · cites it directly · 1 of its ownK013842 Immuno-Trol Low CellsBeckman Coulter, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK141932 Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel…Beckman Coulter, Inc. · 2015 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894651 | Coulter Positive Control Cells | Coulter Corp. | 1989 | — |
| 0 (this device) | K984216 | Immuno-Trol Control Cells | Coulter Corp. | 1999 | — |
| +1 | K013842 | Immuno-Trol Low Cells | Beckman Coulter, Inc. | 2001 | — |
| +1 | K141932 | Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios… | Beckman Coulter, Inc. | 2015 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K894651 | Coulter Positive Control CellsSummary page 1…OF EXPECTED RESULTS section of the Immuno-Trol package insert. Coulter da Mexico S.A, DEC.V Mexico Ctty Mexico Substantial Equivalence: 510(k) Premarket Notification: K894651 Coulter Electronics, Ltd ™ T™ Miidrecht, Netherlands COULTER™ CYTO-TROL™ Control Cells Kit (CYTO-TROL) Coulter Electronics, Pty… | 1989 |
| * | — | Normal Whole Blood (NWB) Named without a submission number |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K013842 (Beckman Coulter, Inc., 2001) has gone furthest, with 1 descendant 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?
IMMUNO-TROL™ Control Cells (Immuno-Trol) is an for an assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of reagent performance and the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by flow cytometry. CD…
Read the full statement (178 words)
IMMUNO-TROL™ Control Cells (Immuno-Trol) is an for an assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of reagent performance and the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by flow cytometry. CD populations intended "For In Vitro Diagnostic Use" and those intended "For Research Use Only. Not For Use In Diagnostic Procedures." are given in separate tables in the TABLE OF EXPECTED RESULTS section of the Immuno-Trol package insert.
Immunophenotyping analysis by flow cytometry involves the identification and enumeration of targeted cells in whole blood samples. Whole blood samples are stained with monoclonal antibodies and erythrocytes are lysed prior to flow cytometric analysis. A positive cell control is required to verify reagent performance, sample performance, sample preparation methods, and staining procedures. A positive cell control should mimic a representative whole blood sample in terms of monoclonal antibody performance, erythrocyte lysing, and flow cytometric analysis.
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/K984216 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984216: Immuno-Trol Control Cells.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984216
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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