# K991876: Sedrite Plus Erythrocyte Sedimentation Rate

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Jun 17, 1999 after 15 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 K940430 (1995). 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)
- K972172: Esr Control-M Hematology Erythrocyte Sedimentation, R&D Systems, Inc. (1997) Summary page 1.

## Indications for use
It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. SEDRite™ Plus is a bi-level control for use in monitoring erythrocyte sedimentation rate (ESR) values obtained from manual and automated ESR methods.

Source page: https://510kreport.com/device/K991876
Methodology: https://510kreport.com/methodology