# K113720: Randox Maternal Control, Levels 1, 2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Sep 20, 2012 after 276 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Blo-Rad Lyphochek Maternal Serum Controls Levels 1, 2 and 3: named in the summary without a submission number

## Indications for use
The Randox Maternal Controls Level 1, Level 2 and Level 3 are intended for in vitro diagnostic use in the quality control of Unconjugtaed Estriol and Total 11-Human Chorionic Gonadotrophin methods on clinical chemistry systems. This in vitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K113720
Methodology: https://510kreport.com/methodology