# K131999: HBA1C Control, Level 1 and Level 2

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jul 26, 2013 after 28 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 K103099 (2010). 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)
- K103099: Precicontrol HBA1C Norm; Precicontrol HBA1C Path, Roche Diagnostics (2010) Summary page 2.

## Indications for use
The HbAlc Controls 'Level I and 2 are intended for in vitro diagnostic use as quality control material for use to verify the performance of laboratory testing procedures of HbAlc on clinical chemistry systems. This in vitro diagnostic device is intended for prescription use only.

Source page: https://510kreport.com/device/K131999
Methodology: https://510kreport.com/methodology