BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2

K132090 · Randox Laboratories, Ltd. · DLJ · Aug 8, 2013 · Clinical Toxicology

Device Facts

• Record ID: K132090
• Device Name: BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
• Applicant: Randox Laboratories, Ltd.
• Product Code: DLJ · Clinical Toxicology
• Decision Date: Aug 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Indications for Use

Randox Benzodiazepine Calibrator Set 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 liguid 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 RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.

Device Story

Liquid calibrators and controls containing Oxazepam in a drug-free human urine matrix; used for calibration and quality control of Benzodiazepine assays on Randox RX series analyzers (RX Daytona, RX Imola). Calibrators assess concentrations below, at, and above the 200 ng/ml cutoff; controls assess performance at levels above and below the cutoff. Used by laboratory technicians in clinical settings to ensure assay accuracy and validation. Output is used by healthcare providers to verify the reliability of patient urine drug screening results, aiding in clinical toxicology assessments.

Clinical Evidence

Bench testing only. Stability studies (real-time and accelerated) confirmed 12-month shelf life for unopened vials and 28-day open-vial stability at 2-8°C. Value assignment performed via nest testing against master lots with acceptance criteria of CV ≤ 15% and recovery error ± 10%.

Technological Characteristics

Liquid-based calibrators and controls; drug-free human urine matrix spiked with Oxazepam. Contains 0.05% sodium azide preservative. Designed for use on Randox RX series analyzers. Stability validated at 2-8°C. No electronic or software components; purely chemical reagent/control material.

Indications for Use

Indicated for the calibration and quality control/validation of Benzodiazepine assays in human urine samples using Randox RX series analyzers (RX Daytona and RX Imola). Intended for prescription use in clinical laboratory settings.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k132090

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.