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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 11, 2024

Microgenics Corporation Nikhita Tandon Manager, Regulatory Affairs 46500 Kato Road Fremont, California 94538

Re: K243498

Trade/Device Name: Alinity c Benzodiazepines Reagent Kit Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine Test System Regulatory Class: Class II Product Code: JXM Dated: November 11, 2024 Received: November 12, 2024

Dear Nikhita Tandon:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/2/Picture/3 description: The image shows the name "Joseph A. Kotarek -S" and a digital signature. The digital signature states that it was signed by Joseph A. Kotarek -S on December 11, 2024, at 14:38:36. The time zone is -05'00'. The name is written in a larger font than the digital signature.

Joseph Kotarek, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K243498

### Device Name Alinity c Benzodiazepines Reagent Kit

### Indications for Use (Describe)

The Alinity o Benzodiazepines Reagent Kit is a homogeneous enzyme immunoassay 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 umol/L) on the Alinity c analyzer.

The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect benzodiazepines in human urine. This assay is calibrated against oxazepam. This product is intended to be used by trained professionals only.

The semiquantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC- MS/MS) or permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid

Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method.

Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------|
| <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Alinity c Benzodiazepines Reagent Kit Special Premarket Notification

# 510(k) Summary K243498

### I. Device Information

| Contact Details | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Microgenics Corporation<br>Thermo Fisher Scientific<br>46500 Kato Road<br>Fremont, CA 94538, USA<br>Phone: [phone] |
| Correspondent Contact Information: | Nikhita Tandon<br>Manager, Regulatory Affairs<br>Email: [e-mail]<br>Phone:[phone] |
| Device Name | |
| Device Trade Name: | Alinity c Benzodiazepines Reagent Kit |
| Common Name: | Benzodiazepine Test System |
| Classification Name: | Enzyme Immunoassay, Benzodiazepine |
| Regulation Number: | 21 CFR 862.3170 |
| Product Code: | JXM |
| Legally Marketed Predicate Device | |
| Predicate Premarket Notification Number: | K173963 |
| Predicate Trade Name: | DRI Benzodiazepine Assay |
| Predicate Common Name: | Benzodiazepine Test System |
| Predicate Classification Name: | Enzyme Immunoassay, Benzodiazepine |
| Predicate Regulation Number: | 21 CFR 862.3170 |
| Predicate Product Code: | JXM |

### ll. Date Summary Prepared

November 11, 2024

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### lll. Description of Device

The Alinity c Benzodiazepines Reagent Kit is a homogeneous enzyme immunoassay with liquid ready to-use reagents. The assay uses a specific antibody that can detect most benzodiazepines and their metabolites in urine. The assay is based on competition between a drug labeled with glucose-6- phosphate dehydrogenase (G6PDH), and free sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the druq labeled with G6PDH and causes a decrease in enzyme activity. In the presence of free drug occupies the antibody binding sites, allowing the drug bound G6PDH to interact with the substrate, resulting in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in urine and enzyme activity is determined spectrophotometrically at 340 nm by measuring the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.

Benzodiazepines are sedative-hypnotic drugs, which are subject to abuse. Benzodiazepines are include a wide variety of drugs such as alprazolam, diazepam, lorazepam, oxazepam, and triazolam. They are absorbed and metabolized at different rates, resulting in various psychoactive effects. Baselt describes the metabolism and toxicology of numerous benzodiazepines, including alprazeoam, chlordiazepoxide, clobazam, clorazepate, diazepan, estazolam, flunitrazepam, halazepam, medazepam, midazolam, nitrazepam, oxazepam, prazepam, quazepam, temazepam, and triazolam.

The Alinity c Benzodiazepines Reagent Kit is a first-line device, which may be used by medical personnel, along with clinical observations, as an aid for indicating Benzodiazeoine abuse through detection of benzodiazepines or their metabolites in urine

### IV. Intended Use

- A. Indications for Use:
See indications for use below.

## B. Intended Use:

The Alinity c Benzodiazepines Reagent Kit is a homogeneous enzyme immunoassay 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 umol/L) on the Alinity c analyzer.

The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect benzodiazepines in human urine. This assay is calibrated against oxazepam. This product is intended to be used by trained professionals only. The semiquantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC- MS/MS) or permitting laboratories to establish quality control

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## procedures.

The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method : 2 Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

### V. Comparison to Predicate Device

| Characteristics | Predicate Device<br>DRI Benzodiazepine Assay (K173963) | Candidate Device<br>Alinity c Benzodiazepines Reagent Kit | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | See intended use below for indications use | See intended use below for indications use | Identical |
| Intended Use | The DRI® Benzodiazepine Assay is a<br>homogeneous enzyme immunoassay<br>intended for the qualitative and/or semi-<br>quantitative determination of the presence of<br>benzodiazepines and their metabolites in<br>human urine at a cutoff concentration of 200<br>ng/mL. The assay is intended to be used in<br>laboratories and provides a rapid analytical<br>screening procedure to detect<br>benzodiazepines in human urine. The assay<br>is designed for use with a number of clinical<br>chemistry analyzers. This assay is calibrated<br>against Oxazepam. This product is intended<br>to be used by trained professionals only.<br>The semi-quantitative mode is for the purpose<br>of enabling laboratories to determine an<br>appropriate dilution of the specimen for<br>confirmation by a confirmatory method such<br>as Liquid Chromatography/tandem mass | The Alinity c Benzodiazepines Reagent Kit is a<br>homogeneous enzyme immunoassay intended<br>for the qualitative and/or semiquantitative<br>determination of the presence of<br>benzodiazepines and their metabolites in<br>human urine at a cutoff concentration of 200<br>ng/mL (0.700 µmol/L) on the Alinity c analyzer.<br>The assay is intended to be used in<br>laboratories and provides a rapid analytical<br>screening procedure to detect<br>benzodiazepines in human urine. This assay is<br>calibrated against oxazepam. This product is<br>intended to be used by trained professionals<br>only.<br>The semi-quantitative mode is for the purpose<br>of enabling laboratories to determine an<br>appropriate dilution of the specimen for<br>confirmation by a confirmatory method such as<br>Liquid Chromatography/Tandem Mass | Identical with exception to the<br>brand name of the device and<br>naming of the clinical<br>chemistry analyzer. This does<br>not impact the intended use of<br>device. |

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| | Predicate Device<br>Characteristics DRI Benzodiazepine Assay (K173963) | Candidate Device<br>Alinity c Benzodiazepines Reagent Kit | Comparison |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | spectrometry (LC-MS/MS) or permitting<br>laboratories to establish quality control<br>procedures.<br>The assay provides only a preliminary<br>analytical test result. A more specific<br>alternative chemical method must be used to<br>obtain a confirmed analytical result. Gas<br>chromatography/ mass spectrometry<br>(GC/MS) or Liquid chromatography/tandem<br>mass spectrometry (LC-MS/MS) is the<br>preferred confirmatory method.<br>Clinical and professional judgment should be<br>applied to any drug of abuse test result,<br>particularly when preliminary results are used.<br>For In Vitro Diagnostic Use Only. | Spectrometry (LC-MS/MS) or permitting<br>laboratories to establish quality control<br>procedures.<br>The assay provides only a preliminary<br>analytical test result. A more specific<br>alternative chemical method must be used to<br>obtain a confirmed analytical result. Gas<br>Chromatography/Mass Spectrometry (GC/MS)<br>or Liquid Chromatography/Tandem Mass<br>Spectrometry<br>(LC-MS/MS) is the preferred confirmatory<br>method.<br>Clinical and professional judgment should be<br>applied to any drug of abuse test result,<br>particularly when preliminary results are used.<br>For In Vitro Diagnostic Use Only. | |
| FDA Product<br>Code | JXM | JXM | Identical |
| Device<br>Classification<br>and Name | 21 CFR 862.3170, ENZYME<br>IMMUNOASSAY, BENZODIAZEPINE<br>Benzodiazepine test system, 91 - Toxicology | 21 CFR 862.3170, ENZYME IMMUNOASSAY,<br>BENZODIAZEPINE<br>Benzodiazepine test system, 91 - Toxicology | Identical |
| Operating<br>Principle<br>(Technology) | Homogeneous Enzyme Immunoassay | Homogeneous Enzyme Immunoassay | Identical |
| | Predicate Device | Candidate Device | |
| Characteristics | DRI Benzodiazepine Enzyme Immunoassay<br>(K173963) | Alinity c Benzodiazepines Reagent Kit | Comparison |
| Analyte | Benzodiazepines | Benzodiazepines | Identical |
| Measured Analyte | Benzodiazepines and their metabolites | Benzodiazepines and their metabolites | Identical |
| Test Matrix | Human Urine | Human Urine | Identical |
| Cut-off Levels | 200 ng/mL | 200 ng/mL | Identical |
| Methodology | Homogeneous Enzyme Immunoassay | Homogeneous Enzyme Immunoassay | Identical |
| Materials | Antibody/Substrate Reagent contains<br>active ingredients: sheep polyclonal anti-<br>benzodiazepine antibodies, glucose-6-<br>phosphate (G6P) and nicotinamide adenine<br>dinucleotide (NAD) and Inactive ingredients:<br>TRIS buffer, bovine serum albumin (BSA).<br>Preservative: sodium azide | Antibody/Substrate Reagent contains<br>active ingredients: Anti-benzodiazepine sheep<br>polyclonal antibodies, glucose-6-phosphate<br>(G6P) and nicotinamide adenine dinucleotide<br>(NAD) and Inactive ingredients: TRIS buffer,<br>bovine serum albumin (BSA). Preservative:<br>sodium azide | Identical |
| | Enzyme Conjugate Reagent contains active<br>ingredients: benzodiazepine derivative labeled<br>with glucose-6-phosphate dehydrogenase<br>(G6PDH) and Inactive ingredients: TRIS<br>buffer, BSA. Preservative: sodium azide | Enzyme Conjugate Reagent contains active<br>ingredients: benzodiazepine derivative labeled<br>with glucose-6-phosphate dehydrogenase<br>(G6PDH) and Inactive ingredients: TRIS buffer,<br>BSA. Preservative: sodium azide | |
| Reagent Form | Liquid ready-to-use<br>Reagents are sold in three sizes, 18 mL, 100<br>mL and 500 mL kits. | Liquid ready-to-use<br>Reagents are sold as 2 cartridges per kit with<br>250 tests per cartridge and 500 tests per kit<br>Volume of R1 per cartridge: 32.2 mL<br>Volume of R2 per cartridge: 31.8 mL | Identical Formulation. Kit<br>available in different sizes |
| Antibody | Sheep Polyclonal Anti-benzodiazepine<br>antibodies | Sheep Polyclonal Anti-benzodiazepine<br>antibodies | Identical |
| Storage | 2-8°C until expiration date | 2-8°C until expiration date | Identical |
| Principal Operator | Trained professionals | Trained professionals | Identical |
| Instrument | Beckman Coulter AU680 Clinical Chemistry<br>Analyzer | Alinity c Analyzer System | Different analyzers, but both<br>meet the following<br>requirements: Automated<br>clinical analyzers capable of<br>maintaining a constant<br>temperature, pipetting, mixing<br>reagents, measuring<br>enzymatic rates at 340 nm and<br>timing the reaction accurately. |

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Image /page/10/Picture/1 description: The image displays the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are in red, with "Scientific" in black underneath. The font is bold and sans-serif, giving the logo a modern and corporate appearance. The logo is simple and recognizable.

| Characteristics | Predicate Device<br>DRI Benzodiazepine Enzyme Immunoassay<br>(K173963) | Candidate Device<br>Alinity c Benzodiazepines Reagent Kit | Comparison |
|-----------------|------------------------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Package Insert | Header and footer | Header and footer | Different, candidate device's<br>header and footer has been<br>modernized to reflect present<br>labeling regulation and<br>practices and branding |

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| Characteristics | Predicate Device<br>DRI Benzodiazepine Enzyme Immunoassay<br>(K173963) | Candidate Device<br>Alinity c Benzodiazepines Reagent Kit | Comparison | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Additional Material | Additional Material | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Ref Kit Description 1664 DRI Negative Calibrator, 10 mL 1388 DRI Negative Calibrator, 25 mL 1588 DRI Multi-Drug Urine Calibrator 1, 10 mL 1589 DRI Multi-Drug Urine Calibrator 1, 25 mL 1591 DRI Multi-Drug Urine Calibrator 2, 10 mL 1592 DRI Multi-Drug Urine Calibrator 2, 25 mL 1594 DRI Multi-Drug Urine Calibrator 3, 10 mL 1595 DRI Multi-Drug Urine Calibrator 3, 25 mL 1597 DRI Multi-Drug Urine Calibrator 4, 10 mL 1598 DRI Multi-Drug Urine Calibrator 4, 25 mL DOAT-4 MAS® DOA Total-Level 4 DOAT-5 MAS® DOA Total-Level 5 | | | | | | | | | | | | | | | | | | | | | | | | | | | Ref Kit Description 08P6306 Alinity c DOA MC Negative<br>Calibrator Kit 09P5201 Alinity c Benzodiazepines Qual<br>Calibrator Kit 09P5202 Alinity c Benzodiazepines<br>Semiquant Calibrator Kit 08P6318 Alinity c DOA MC I Controls | | | | | | | | | | | Calibrators and Controls are<br>Identical in formulation but<br>assigned different Ref.<br>numbers.<br><br>DOA MC Cals/controls contain<br>Oxazepam and are traceable<br>to the Oxazepam drug<br>purchased from a commercial<br>source which is established at<br>98% purity. |

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## Alinity c Benzodiazepines Reagent Kit Special Premarket Notification

| Characteristics | Predicate Device | Candidate Device | Comparison |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| | DRI Benzodiazepine Enzyme Immunoassay<br>(K173963) | Alinity c Benzodiazepines Reagent Kit | |
| | Precautions and Warnings | Precautions and Warnings | Different, candidate device<br>precautions and warnings have<br>been modernized to reflect<br>present safety regulations. |
| | The reagents are harmful if swallowed. | | |
| | | • [IVD] | |
| | DANGER: | • For In Vitro Diagnostic Use | |
| | 1. The reagents contain ≤ 0.2% bovine serum<br>albumin (BSA) and ≤0.5% Drug-specific | • [Rx Only]<br>Safety Precautions | |
| | antibody (Sheep). Avoid contact with skin and | CAUTION: This product requires the handling | |
| | mucous membranes. Avoid inhalation.<br>May cause skin or inhaled allergic reaction. | of human specimens. It is recommended that<br>all human-sourced materials and all | |
| | 2. In the case of accidental spill, clean and | consumables contaminated with potentially | |
| | dispose of material according to your | infectious materials be considered potentially |…