# K091433: R&D Systems Tetic-I Plus Hemotology Control

- Pathway: 510(k) (Special)
- Applicant: R&D Systems, Inc.
- Decided: Oct 28, 2009 after 168 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: 1 generation back to K010461 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010461: Advia Retic Plus, R&D Systems, Inc. (2001)

## Indications for use
R&D Retic-I Plus Control is a tri-level, assayed hematology control designed to monitor values obtained from automated reticulocyte counting methods.

Source page: https://510kreport.com/device/K091433
Methodology: https://510kreport.com/methodology