# K984216: Immuno-Trol Control Cells

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Mar 16, 1999 after 112 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K894651 (1989). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894651: Coulter Positive Control Cells, Coulter Corp. (1989) Summary page 1.
- (no number) Normal Whole Blood (NWB): named in the summary without a submission number

## Most influential descendants
- K013842: Immuno-Trol Low Cells (2001), 1 descendant of its own
- K141932: Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol, Aquios Immuno-Trol Low, Aquios (2015), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K984216
Methodology: https://510kreport.com/methodology