# K131776: Aldolase Controls Level 2, and Aldolase Control Level 3

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jul 18, 2013 after 31 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: 1 generation back to K000875 (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)
- K000875: Assayed QCS 1,2, Cat. Nos. 970200, 970500, Bio-Rad (2000) Summary page 1.

## Indications for use
The Randox Aldolase Controls Level 2 and Aldolase Control Level 3 are intended for in vitro diagnostic use as assayed quality control materials for the quantitative determination of Aldolase on the clinical chemistry analysers indicated in the package insert. This device is for prescription use only. This in vitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K131776
Methodology: https://510kreport.com/methodology