# K051928: AUTOCHECK6+

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medical Aps
- Decided: Oct 12, 2005 after 86 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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: 4 generations back to K861087 (1986). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980135: QUALICHECK5+ Models S7730, S7740, S7750, S7760, Radiometer America, Inc. (1998) Summary page 1.
- K992859: ABL700 Series Analyzer with Autocheck Module, Radiometer America, Inc. (2000) Summary page 1.

## Indications for use
The AutoCheck6+ is a liquid four ampoule quality control system for checking the precision and accuracy of Radiometer Medical ApS analyzers for pH/Blood Gases, Co-oximetry, Electrolytes, Bilirubin, Glucose, Lactate, and Creatinine.

Source page: https://510kreport.com/device/K051928
Methodology: https://510kreport.com/methodology