# K072869: Pointcare Now System

- Pathway: 510(k) (Traditional)
- Applicant: Pointcare Technologies, Inc.
- Decided: Jan 14, 2008 after 97 days
- Product code: GKZ (Counter, Differential Cell)
- 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: 4 generations back to K922745 (1993). 21 ancestors in all.
No later device cites it as a predicate yet.
2 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041882: Flowcare System, Pointcare Technologies, Inc. (2004) Summary page 1.
- K991539: Excell 22, Mwi, Inc. (1999) Summary page 1.
- K992875: Sysmex XE-2100, Automatated Hematology Analyzer, Sysmex Corp. (1999) Summary page 1.
- K043215: Flowcare PLG CD4 Reagent, Beckman Coulter, Inc. (2005) Summary page 1.

## Recalls of this device
- Nov 2, 2011 · Not classified · Z-1193-2012: Stability not assured at labeled temperature 2-42C

## Indications for use
The PointCare NOW System is an automated hematology system intended for in vitro diagnostic use in performing the direct enumeration of major white blood cell populations, certain T-lymphocyte subsets, and hemoglobin concentration from human whole blood. Whole blood samples can be analyzed with the PointCare NOW System for the following parameters: * White Blood Cell Count * Lymphocyte Count * Lymphocyte Percentage (of White Blood Cells) * CD4 T-Lymphocyte Count * CD4 Percentage (of total Lymphocytes) * Monocyte Count * Monocyte Percentage (of White Blood Cells) * Neutrophil Count * Neutrophil Percentage (of White Blood Cells) * Eosinophil Count * Eosinophil Percentage (of White Blood Cells) * Hemoglobin Concentration The PointCare NOW System and its methods for analysis are intended for in vitro diagnostic use in clinical laboratory settings.

Source page: https://510kreport.com/device/K072869
Methodology: https://510kreport.com/methodology