# K053497: Guava EZCD4 System

- Pathway: 510(k) (Traditional)
- Applicant: Guava Technologies, Inc.
- Decided: Apr 14, 2006 after 120 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K946055 (1996). 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)
- K974360: Multitest CD3/CD8/CD45/CD4, Becton Dickinson Immunocytometry Systems (1998) Summary page 1.
- K965053: Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes, Becton Dickinson Immunocytometry Systems (1997) Summary page 1.

## Indications for use
The EZCD4 Assay is intended to be performed on a Guava PCA System with CytoSoft 2.3 version software which includes three modules; EZCD4, Guava Check and Clean and Shutdown. The system is intended to identify and quantify the absolute counts of CD4 T-Lymphocytes in EDTA whole blood. The GuavaEZCD4 system is intended for the ongoing monitoring of patients with documented diagnosis of an immunodeficiency disease. The Guava EZCD4 system is intended for use only by trained laboratory professionals.

Source page: https://510kreport.com/device/K053497
Methodology: https://510kreport.com/methodology