Alinity c Benzodiazepines Reagent Kit

K243498 · Microgenics Corporation · JXM · Dec 11, 2024 · Clinical Toxicology

Device Facts

• Record ID: K243498
• Device Name: Alinity c Benzodiazepines Reagent Kit
• Applicant: Microgenics Corporation
• Product Code: JXM · Clinical Toxicology
• Decision Date: Dec 11, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Intended Use

The assay intended for the qualitative and/or semiquantitative determination of the presence of benzodiazepines and their metabolites in human urine at a cutoff concentration of 200 ng/mL (0.700 μmol/L).

Device Story

The Alinity c Benzodiazepines Reagent Kit is a homogeneous enzyme immunoassay for the detection of benzodiazepines in human urine. It utilizes a competitive binding principle: drug in the urine sample competes with drug-labeled glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of specific sheep polyclonal antibody binding sites. In the absence of drug, the antibody binds the G6PDH-labeled drug, inhibiting enzyme activity. In the presence of drug, the antibody binds the sample drug, leaving the G6PDH-labeled drug free to interact with the substrate, resulting in enzyme activity. This activity is measured spectrophotometrically at 340 nm by the conversion of NAD to NADH. The device is used in clinical laboratories on the Alinity c analyzer system. Results are used by trained professionals as a preliminary screen to identify potential benzodiazepine abuse, requiring confirmation by GC/MS or LC-MS/MS. The device aids clinical decision-making by providing rapid, preliminary analytical results for drug screening.

Clinical Evidence

Bench testing only. Verification and validation activities performed based on risk analysis to support the extension of the assay to the Alinity c Analyzer System.

Technological Characteristics

In vitro diagnostic reagent kit for clinical chemistry analyzers. Uses established immunoassay technology for benzodiazepine detection. No change to fundamental scientific technology.

Indications for Use

Indicated for the qualitative and/or semiquantitative detection of benzodiazepines and their metabolites in human urine at a 200 ng/mL cutoff. Intended for use by trained laboratory professionals as a rapid screening procedure. Not for over-the-counter use.

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).

Predicate Devices

• DRI Benzodiazepine Assay (K173963)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K243498

B Applicant

Microgenics Corporation

C Proprietary and Established Names

Alinity c Benzodiazepines Reagent Kit

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JXM | Class II | 21 CFR 862.3170 - Benzodiazepine Test System | TX - Clinical Toxicology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own class II device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the submitter's previously cleared device. DRI Benzodiazepine Assay (K173963)
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This modification was to extend the validation of the Alinity c Benzodiazepines Reagent Kit from its predicate (named DRI Benzodiazepine Assay) on the Beckman Coulter AU680 Clinical Chemistry Analyzer (K173963) to the Alinity c Analyzer System (K243498). The assay intended for the qualitative and/or semiquantitative determination of the presence of benzodiazepines and their metabolites in human urine at a cutoff concentration of 200 ng/mL (0.700 μmol/L) remains the same.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

6. The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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