# K132090: Benzodiazepine Calibrator Set, Benzodiazepine Control Level 1, and Benzodiazepine Control Level 2

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Aug 8, 2013 after 27 days
- Product code: DLJ (Calibrators, Drug Specific)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983159 (1998). 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)
- K051088: Multiple Analyte Urine Drugs of Abuse Calibrators and Controls, Lin-Zhi International, Inc. (2005) Summary page 2.

## Indications for use
The Randox Benzodiazepine Calibrator set consists of liquid calibrators containing Oxazepam. There are 5 levels of calibrator. They have been developed for use in the calibration of the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only. Randox Benzodiazepine Controls Level 1 &2 The Randox Benzodiazepine Controls are liquid controls containing Oxazepam. There are 2 levels of controls. They have been developed for use in the quality control and validation of Benzodiazepine assay on the RX series analysers in human urine, which includes the RLX Daytona and the ICC Imola. This in vitro diagnostic device is intended for prescniption use only.

Source page: https://510kreport.com/device/K132090
Methodology: https://510kreport.com/methodology