# K152117: Dropper hsCRP High Sensitivity CRP Control

- Pathway: 510(k) (Traditional)
- Applicant: Quantimetrix Corporation
- Decided: Apr 21, 2016 after 266 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: 7 generations back to K961828 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123663: Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel Minipak, Bio-Rad Laboratories (2012) Summary page 4.

## Indications for use
The Quantimetrix Dropper hsCRP High Sensivity CRP Control is intended for the quality control of laboratory testing procedures of high sensitivity C-Reactive protein (CRP). It is intended for professional in vitro diagnostic use only.

Source page: https://510kreport.com/device/K152117
Methodology: https://510kreport.com/methodology