# K013898: R&D Ret-Line Kit

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Jan 22, 2002 after 60 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 K000115 (2000). 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)
- K000115: Retic Chex Linearity, Streck Laboratories, Inc. (2000) Summary page 1.

## Indications for use
R&D RET-LINE Kit is a multi-level linearity control that provides a means of measuring the linearity of automated hematology analyzers for reticulocyte parameter determinations.

Source page: https://510kreport.com/device/K013898
Methodology: https://510kreport.com/methodology