# K034048: R&D Glu-Line Hematology Control

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Mar 10, 2004 after 71 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K934641 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993321: R&D HGB/GLC Whole Blood Control, R&D Systems, Inc. (1999) Summary page 1.

## Indications for use
R&D GLU-LINE Hematology Control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for glucose parameter determinations.

Source page: https://510kreport.com/device/K034048
Methodology: https://510kreport.com/methodology