# K150815: BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Dec 17, 2015 after 265 days
- Product code: PMG (Automated Multicolor Fluorescent Imaging Cytometric Analysis System)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K920997 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071141: BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402, Bd Biosciences (2007) Summary page 7.
- K961610: R & D Systems' Whole Blood Flow Control, (R & D - WBFC), R&D Systems, Inc. (1996) Summary page 7.
- K982231: Statusflow, R&D Systems, Inc. (1998) Summary page 7.
- K030067: Vitros Immunodiagnostic Products Hbsag Controls, Ortho-Clinical Diagnostics (2003) Summary page 7.

## Cited in the summary but kept off the family tree
- K990005: Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System, Spinal Concepts, Inc. (1999). The summary prints BK990005, a CBER number, which our reading took as K990005, FDA’s number for Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System (Spinal Concepts, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “R&D Systems’ Whole Blood Flow Control (StatusFlow)”. Kept off the family tree. Summary page 7.

## Recalls of this device
- Oct 5, 2020 · Class II · Z-0562-2021: Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.

## Indications for use
The BD FACSPresto System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums. • For use with the BD FACSPresto™ CD4/Hb Cartridge and BD FACSPresto™ CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings. • For use in children, adolescents, and adults. • For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes. • Not for point-of-care use. • For in vitro diagnostic use. The BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto™ System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings. • For use in children, adolescents, and adults • For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes. • Not for point-of-care use. • For in vitro diagnostic use. The BD™ Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis. The BD™ Multi-Check control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer. The BD™ Multi-Check CD4 low control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis. The BD™ Multi-Check CD4 low control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer. Eurotrol FACSPresto Hb Control is an assayed hemoglobin control intended for in vitro diagnostic use in the verification of the precision and accuracy of the BD FACSPresto™ System.

Source page: https://510kreport.com/device/K150815
Methodology: https://510kreport.com/methodology