# K013842: Immuno-Trol Low Cells

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 13, 2001 after 23 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: 2 generations back to K894651 (1989). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K984216: Immuno-Trol Control Cells, Coulter Corp. (1999) Summary page 1.

## Most influential descendants
- 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™ 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.

Source page: https://510kreport.com/device/K013842
Methodology: https://510kreport.com/methodology