# K141932: Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol, Aquios Immuno-Trol Low, Aquios

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Apr 10, 2015 after 268 days
- Product code: OYE (Flow Cytometric Reagents And Accessories.)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K946055 (1996). 20 ancestors in all.
No later device cites it as a predicate yet.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961623: Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp Beads, Becton Dickinson Monoclonal Center (1996) Summary page 8.
- K973483: Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set, Becton Dickinson Immunocytometry Systems (1998) Summary page 8.
- K974360: Multitest CD3/CD8/CD45/CD4, Becton Dickinson Immunocytometry Systems (1998) Summary page 8.
- K980858: Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution, Becton Dickinson Immunocytometry Systems (1998) Summary page 8.
- K140911: Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System, Beckman Coulter, Inc. (2014). Cleared while this submission was under review Summary page 8.
- K984216: Immuno-Trol Control Cells, Coulter Corp. (1999) Summary page 8.
- K013842: Immuno-Trol Low Cells, Beckman Coulter, Inc. (2001) Summary page 8.

## Recalls of this device
- Jan 29, 2018 · Class II · Z-1341-2018: The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identificat
- Oct 2, 2017 · Class II · Z-0091-2018: The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)
- Aug 21, 2017 · Class II · Z-3135-2017: Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a 
- Apr 3, 2017 · Class II · Z-2035-2017: Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files.
- Oct 19, 2016 · Class II · Z-0648-2017: Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of notifications and flags when used on the AQUIOS CL when running the AQUIOS Tetra application.
- Sep 6, 2016 · Class II · Z-2900-2016: Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe.

## Indications for use
The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV). It is used in conjunction with the following reagents and software package. AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of; - AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent • Total CD3+, CD3+CD4+,CD3+CD8+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts. • CD45+ absolute count • CD45+ Low SS (lymphocytes) percentage and absolute count AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent • Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts. • CD45+ absolute count • CD45+ Low SS (lymphocytes) percentage and absolute count AQUIOS Flow Cytometry Software may be run on an independent computer workstation for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with the monoclonal antibody reagents listed above. The off-line analysis must be performed in accordance with the product labeling. AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of; - AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent • Total CD3+, CD3+CD4+,CD3+CD8+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts. • CD45+ absolute count • CD45+ Low SS (lymphocytes) percentage and absolute count - AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent • Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts. • CD45+ absolute count • CD45+ Low SS (lymphocytes) percentage and absolute count AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells. AQUIOS IMMUNO-TROL Cells are 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 instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer. AQUIOS IMMUNO-TROL Low Cells are 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 instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.

Source page: https://510kreport.com/device/K141932
Methodology: https://510kreport.com/methodology