# K072846: CSF Automated Control, Models CSF001, CSF003

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Nov 26, 2007 after 53 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000076 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022968: Advia Testpoint CSF Control, Bayer Diagnostics Corp. (2002) Summary page 1.

## Indications for use
CSF AUTOMATED CONTROLS is an assayed control designed to monitor values obtained using hematology instruments that measure CSF samples.

Source page: https://510kreport.com/device/K072846
Methodology: https://510kreport.com/methodology