# K041130: CDS Hematology Calibrator (CDS Cal)

- Pathway: 510(k) (Abbreviated)
- Applicant: Clinical Diagnostic Solutions, Inc.
- Decided: Jun 10, 2004 after 41 days
- Product code: KRZ (Calibrator For Hemoglobin And Hematocrit Measurement)
- Device class: 2
- Regulation: 21 CFR 864.8165
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CDS Hematology Calibrator for red cell, white cell and platelet counting is a device that resembles red cells, white cells and platelets in whole blood specimens and is intended to serve as a calibration standard for automated hematology analyzers, including Beckman Coulter S Plus IL-VI series, STKR, JS, JR, ST and JT series, STKS, MAXM, HmX, Gen.S, MD series, OnyX, T series and AT and AT diff series analyzers; the Abbott Cell-Dyn 1400, 1500, 1600 and 1700 analyzers; and the Danam EXCEL 16 and EXCEL 22 analyzers, intended to count red cells, white cells and platelets. It is a suspension of particles or cells whose size, shape, concentration and other characteristics have been precisely and accurately determined.

Source page: https://510kreport.com/device/K041130
Methodology: https://510kreport.com/methodology