ONLINE DAT Benzodiazepines II

K221765 · Roche Diagnostics · JXM · Dec 23, 2022 · Clinical Toxicology

Device Facts

• Record ID: K221765
• Device Name: ONLINE DAT Benzodiazepines II
• Applicant: Roche Diagnostics
• Product Code: JXM · Clinical Toxicology
• Decision Date: Dec 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Indications for Use

Benzodiazepines II (BNZ2) is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzodiazepines in human urine on cobas c systems at cutoff concentrations of 100 ng/mL, 200 ng/mL, and 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC-MS), or Liquid Chromatography coupled with Tandem Mass Spectrometry (LC-MS/MS). Benzodiazepines II provides only a preliminary analytical test result. A more specific alternical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC-MS) or Liquid Chromatography coupled with Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

In vitro diagnostic immunoassay for benzodiazepine detection in human urine. Uses kinetic interaction of microparticles in solution (KIMS) on automated cobas c systems. Reagents contain monoclonal/polyclonal antibodies, substrate, and enzyme-labeled drug conjugate. Principle: drug in sample competes with particle-bound drug for antibody; inhibition of particle aggregation measured photometrically via turbidity. Presence of p-glucuronidase enhances cross-reactivity to glucuronidated metabolites. Used in clinical laboratories by technicians/pathologists. Output: qualitative (positive/negative) or semiquantitative (ng/mL) results. Preliminary results require confirmation by GC-MS or LC-MS/MS. Clinical decision-making relies on professional judgment alongside test results. Benefits: rapid screening for drug abuse assessment.

Clinical Evidence

Bench testing only. Precision (CLSI EP5-A3), linearity (CLSI EP6-A), analytical specificity, and interference studies performed. Method comparison study evaluated 137 samples against LC-MS/MS confirmation. Results showed 100% agreement for negative and positive clinical samples at 100, 200, and 300 ng/mL cutoffs. Stability testing confirmed 12-week onboard reagent stability.

Technological Characteristics

KIMS (Kinetic interaction of microparticles in solution) assay. Photometric turbidity measurement. Two liquid reagents: antibody buffer and conjugated drug microparticles. Includes p-glucuronidase for enzymatic cleavage of glucuronidated metabolites. Automated platform (cobas c 501). Storage 2-8°C.

Indications for Use

Indicated for qualitative and semiquantitative detection of benzodiazepines in human urine for clinical laboratory use on cobas c systems. Cutoff concentrations: 100, 200, and 300 ng/mL. Provides preliminary analytical results; requires confirmation by GC-MS or LC-MS/MS.

Regulatory Classification

Identification

A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A benzodiazepine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Submission Summary (Full Text)

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

510(k) Number: K221765

This 510(k) was reviewed under the OHT7/OHT8 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.