# K972170: Esr Control-HC Hematology Erythrocyte Sedimentation

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Jul 24, 1997 after 45 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 K940430 (1995). 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)
- K940430: Sedratrol, Medical Specialties Intl., Inc. (1995) Summary page 1.

## Indications for use
It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. ESR Control-HC™ is a bi-level hematology control designed to document and monitor values obtained from HiChem Mini-VES and VES-Matic automated erythrocyte sedimentation rate analyzers.

Source page: https://510kreport.com/device/K972170
Methodology: https://510kreport.com/methodology