# K121746: Randox Microalbumin Control Level 1 and Control Level 2 (Liquid)

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jul 11, 2012 after 27 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 K971954 (1997). 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)
- K072835: Liquichek Microalbumin Control Level 1, Level 2, Control Minipak, Bio-Rad, Diagnostics Grp. (2007) Summary page 1.

## Indications for use
The Randox Microalbumin Liquid Controls are designed for use as assayed quality control materials for the quantitative determination of albumin in human urine. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

Source page: https://510kreport.com/device/K121746
Methodology: https://510kreport.com/methodology