ONLINE DAT BENZODIAZEPINES PLUS

K043327 · Roche Diagnostics Corp. · JXM · Feb 7, 2005 · Clinical Toxicology

Device Facts

• Record ID: K043327
• Device Name: ONLINE DAT BENZODIAZEPINES PLUS
• Applicant: Roche Diagnostics Corp.
• Product Code: JXM · Clinical Toxicology
• Decision Date: Feb 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Intended Use

The ONLINE DAT Benzodiazepines Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/mL, 200 ng/mL, and 300 ng/mL. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

Device Story

In vitro diagnostic assay for benzodiazepine detection in human urine; utilizes Kinetic Interaction of Microparticles in Solution (KIMS) technology. Input: human urine sample; Principle: competitive immunoassay where drug in sample competes with drug-conjugated microparticles for sheep polyclonal antibody binding sites; Output: change in light transmission/absorbance measured by automated clinical chemistry analyzers. Absence of drug leads to particle aggregation and increased absorbance; presence of drug inhibits aggregation, decreasing absorbance relative to cutoff. Used in clinical laboratories by technicians/pathologists to assess benzodiazepine presence. Results assist healthcare providers in clinical decision-making regarding drug screening. Benefits include rapid, automated, semi-quantitative assessment of drug presence.

Clinical Evidence

No clinical data provided; substantial equivalence based on analytical performance characteristics and technological comparison to predicate.

Technological Characteristics

KIMS (Kinetic Interaction of Microparticles in a Solution) immunoassay. Reagents: monoclonal/polyclonal antibodies, substrate, enzyme-labeled drug conjugate. Automated clinical chemistry analyzer platform (Hitachi 917, 911, 912, Modular P/DAT). Liquid reagents stored at 2-8°C. Qualitative/semi-quantitative output.

Indications for Use

Indicated for qualitative and semi-quantitative detection of benzodiazepines in human urine for individuals requiring drug testing. Used on automated clinical chemistry analyzers at 100, 200, and 300 ng/ml cutoffs.

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

• Roche Abuscreen OnLine Benzodiazepines Assay (k983702)

Submission Summary (Full Text)

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# 510(k) Summary

K 043327

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter name, address, contact | Roche Diagnostics 9115 Hague Rd. Indianapolis, IN 46250 [phone] |
| | Contact Person: Kerwin Kaufman Date Prepared: December 1, 2004 |
| 2) Device name | Proprietary name: ONLINE DAT Benzodiazepines Plus Common name: Benzodiazepines test system Classification name: Enzyme immunoassay, Benzodiazepines |
| 3) Predicate device | We claim substantial equivalence to the currently marketed Abuscreen OnLine Benzodiazepines assay (K983702). |

Continued on next page

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The Roche ONLINE DAT Benzodiazepines Plus assay is an in vitro 4) Device Description diagnostic test for the qualitative and semi-quantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers 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.

### Principal of procedure

The ONLINE DAT Benzodiazepines Plus assay is based on the kinetic interaction of microparticles in a solution (KIMS technology). Assay measurement is based on measurable changes in light transmission related to the interaction of microparticles in a solution and the sample drug of interest. if present. Benzodiazepine drug derivative is conjugated to microparticles in solution, and benzodiazepine polyclonal antibody (sheep) is solubilized in In the absence of sample drug, free antibody binds to drugbuffer. microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases.

When a urine sample contains the drug in question, this drug competes with the particle-bound drug derivative for free antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

#### Negative Sample

drug-conjugated microparticles + free antibody = particle aggregates (↑ absorbance)

#### Positive Sample

sample drug + drug-conjugated microparticle = particle aggregation inhibited drug-conjugated microparticles + free antibody = particle aggregates

Continued on next page

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# 510(k) Summary, Continued

Benzodiazepines Plus is an in vitro diagnostic test for the qualitative and 5.) Intended semi-quantitative detection of benzodiazepines in human urine on automated Use clinical chemistry analyzers at cutoff concentrations of 100 ng/ml, 200 ng/ml and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

The Roche ONLINE DAT Benzodiazepine Plus assay is substantially 6.) Comparison to the Predicate equivalent to other products in commercial distribution intended for similar Device use. Most notably, it is substantially equivalent to the currently marketed Roche Abuscreen OnLine Benzodiazepines (K983702).

> Both the new and predicate device assays are based on the kinetic interaction of microparticles in a solution (KIMS technology). Differences between this application and the predicate cleared assay include:

- a change in the accelerant / activator contained in the diluent . solution used to make the antibody working solution (R1 reagent),
- a change in polyclonal antibody purification from non-specific . IgG binding to immunoaffinity purification,
- improved precision, and .
- use of new (previously cleared) calibrators and unassayed controls.

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FEB - 7 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kerwin Kaufman, MBA, MT (ASCP) Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457

k043327 Re:

Trade/Device Name: ONLINE DAT Benzodiazepines Plus Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: Class II Product Code: JXM Dated: December 1, 2004 Received: December 2, 2004

Dear Mr. Kaufman:

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 (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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Jean McCogger, MS, DUM

Jean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): k043327

ONLINE DAT Benzodiazepines Plus Device Name:

Indications For Use:

Benzodiazepines Plus is an in vitro diagnostic test for the qualitative and semi-Buantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/ml, 200 ng/ml and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off
acting

Office of In Vitro Diagnostic

510(k) K043321

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