# K993375: CDS LTX Control Latex Particle Suspension and Primer

- Pathway: 510(k) (Abbreviated)
- Applicant: Clinical Diagnostic Solutions, Inc.
- Decided: Dec 20, 1999 after 74 days
- Product code: KRX (Calibrator For Cell Indices)
- Device class: 2
- Regulation: 21 CFR 864.8150
- 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. The FDA summary names no predicate by number.

## Indications for use
CDS LTX-Control Latex Particle Suspension is intended to serve as a calibration standard for the d.c. impedance, r.f impedance and optical light scatter parameters of the VCS module of Coulter® Models STKS, MAXM and GeneS Hematology Analyzer systems. Models STKS and MAXM analyzers equipped with 5-part differential capability only require aspiration of the CDS LTX-Control Latex Particle Suspension through the secondary mode aspiration inlet with the analyzer set to function F55. STKS and Gene$S analyzers equipped with 5-part differential and reticulocyte capability require aspiration of the CDS LTX-Control Latex Particle Suspension through the secondary mode aspiration inlet with the analyzer set to function F57.

Source page: https://510kreport.com/device/K993375
Methodology: https://510kreport.com/methodology