# K073178: HCT Extended Hematology Control, Model HCT004

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Dec 27, 2007 after 44 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 K843962 (1984). 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)
- K843962: CBC-PLT-4 Whole Blood Control/Multiple, R&D Systems, Inc. (1984) Summary page 1.

## Indications for use
It is an established laboratory procedure to use a stable control to monitor the performance of diagnostic tests. HCT Extended Hematology Control is an assayed control designed to monitor values obtained from automated, semi-automated and manual methods. For in vitro Diagnostic Use Only

Source page: https://510kreport.com/device/K073178
Methodology: https://510kreport.com/methodology