ONLINE DAT BARBITURATES PLUS

K043211 · Roche Diagnostics Corp. · DIS · Dec 29, 2004 · Clinical Toxicology

Device Facts

• Record ID: K043211
• Device Name: ONLINE DAT BARBITURATES PLUS
• Applicant: Roche Diagnostics Corp.
• Product Code: DIS · Clinical Toxicology
• Decision Date: Dec 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3150
• Device Class: Class 2

Intended Use

Barbiturates Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose. Barbiturates Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

Device Story

In vitro diagnostic assay for barbiturate detection in human urine; utilizes kinetic interaction of microparticles in solution (KIMS) on automated clinical chemistry analyzers (Roche/Hitachi 911/912/917/MODULAR). Input: urine sample; reagents (secobarbital antibody, conjugated secobarbital derivative microparticles). Principle: drug in sample competes with particle-bound drug for antibody; inhibition of particle aggregation measured by light absorbance changes. Output: qualitative (positive/negative) or semi-quantitative concentration result. Used in clinical laboratories by technicians/lab staff. Results provide preliminary screening; require confirmation via GC/MS. Assists clinicians in diagnosing/treating barbiturate use or overdose.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing of assay performance using KIMS technology.

Technological Characteristics

KIMS (Kinetic Interaction of Microparticles in Solution) technology; competitive immunoassay. Reagents: secobarbital-conjugated microparticles and sheep polyclonal antibody. Automated clinical chemistry analyzer platform. Qualitative/semi-quantitative output based on light transmission/absorbance changes.

Indications for Use

Indicated for the qualitative and semi-quantitative detection of barbiturates in human urine for the diagnosis and treatment of barbiturate use or overdose. For use on automated clinical chemistry analyzers at a 200 ng/mL cutoff. Prescription use only.

Regulatory Classification

Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A barbiturate 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

• Abuscreen OnLine Barbiturates assay (K983698)

Submission Summary (Full Text)

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DEC 2, 9 2004

# 510(k) Summary

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<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone]<br>Contact Person: Kerwin Kaufman<br>Date Prepared: November 18, 2004 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Proprietary name: ONLINE DAT Barbiturates Plus<br>Common name: Barbiturate test system<br>Classification name: Enzyme immunoassay, Barbiturate |
| 3) Predicate device | We claim substantial equivalence to the currently marketed Abuscreen OnLine Barbiturates assay (K983698). |

Continued on next page

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### 510(k) Summary, Continued

The Roche ONLINE DAT Barbiturates Plus assay is an in vitro diagnostic 4) Device Description test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/ml. Semi-quantitative 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 Barbiturates 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. Secobarbital drug derivative is conjugated to microparticles in solution, and secobarbital polyclonal antibody (sheep) is solubilized in buffer. In the absence of sample drug, free antibody binds to drug-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

Barbiturates Plus is an in vitro diagnostic test for the qualitative and semi-5.) Intended Use quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 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 Barbiturates Plus is substantially equivalent to 6.) Comparison to the Predicate other products in commercial distribution intended for similar use. Most Device notably, it is substantially equivalent to the currently marketed Roche Abuscreen OnLine Barbiturates (K983698). 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), and . use of new (previously cleared) calibrators and unassayed controls.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines representing movement or connection.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 9 2004

Mr. Kerwin Kaufman, MBA, M.T. (ASCP) Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k043211

> Trade/Device Name: ONLINE DAT Barbiturates Plus Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS Dated: November 18, 2004 Received: November 19, 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,

petiry

Cornelia B. Rooks, MA Acting 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): K043211

Device Name: ONLINE DAT Barbiturates Plus

Indications For Use:

Barbiturates Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose. Barbiturates Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

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 GDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

5100 K0432//

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