# K130415: High Metabolite Qualicheck

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medical Aps
- Decided: Mar 26, 2013 after 35 days
- Product code: JJS (Controls For Blood-Gases, (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 K952725 (1996). 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)
- K980135: QUALICHECK5+ Models S7730, S7740, S7750, S7760, Radiometer America, Inc. (1998) Summary page 1.

## Indications for use
This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges. Analytes are: pO2, ctHb, cGlucose, cLactate

Source page: https://510kreport.com/device/K130415
Methodology: https://510kreport.com/methodology