510(k) · Cleared
ClearedImmuno-Trol Low Cells
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JPK Mixture, Hematology Quality Control
Cleared on Dec 13, 2001 as substantially equivalent to K984216 (Coulter Corp., 1999) after a 23-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Dec 13, 2001
- Review
- 23 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K894651 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK894651 Coulter Positive Control CellsCoulter Corp. · 1989
- 1 generation backK984216 Immuno-Trol Control CellsCoulter Corp. · 1999
- This deviceK013842 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 1 of 1 · See all- K141932Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol…Beckman Coulter, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894651 | Coulter Positive Control Cells | Coulter Corp. | 1989 | — |
| −1 | K984216 | Immuno-Trol Control Cells | Coulter Corp. | 1999 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K984216 | Immuno-Trol Control CellsSummary page 1…™ Low Cells 3.2 Classification Name Hematology quality control mixture (21 CFR § 864.8625) 4.0 Predicate Device: IMMUNO-TROL™ Low IMMUNO-TROL™ Beckman Coulter, Inc. | K984216 Cells Cells 50 Description: IMMUNO-TROL™ Low Cells is a liquid preparation of stabilized erythrocytes and leukocytes in a stabi… | 1999 |
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 |
|---|---|---|---|
| K141932 | Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol… | 2015 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K141932 (Beckman Coulter, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K984216.
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™ Low Cells is 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 of targeted cells, lysing erythrocytes, and analyzing samples by flow cytometry. The product is intended “For…
Read the full statement (147 words)
IMMUNO-TROL™ Low Cells is 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 of targeted cells, lysing erythrocytes, and analyzing samples by flow cytometry. The product is intended “For In Vitro Diagnostic Use.”
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/K013842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013842: Immuno-Trol Low Cells.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013842
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026