ONLINE DAT PROPOXYPHENE PLUS

K043303 · Roche Diagnostics Corp. · JXN · Mar 11, 2005 · Clinical Toxicology

Device Facts

• Record ID: K043303
• Device Name: ONLINE DAT PROPOXYPHENE PLUS
• Applicant: Roche Diagnostics Corp.
• Product Code: JXN · Clinical Toxicology
• Decision Date: Mar 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3700
• Device Class: Class 2

Intended Use

Propoxyphene Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of propoxyphene and its metabolites in human urine on the Roche Hitachi automated clinical chemistry family of analyzers at a cutoff of 300 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 of propoxyphene use or abuse and do not measure a level of toxicity. Propoxyphene Plus screening test provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method, such as gas chromatograph - mass spectrometer (GC/MS) should be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. The device is for in vitro diagnostic use.

Device Story

Wet chemistry immunoassay (KIMS) for detection of propoxyphene in human urine; utilizes Roche Hitachi automated clinical chemistry analyzers. Input: urine sample; R1 reagent (goat polyclonal antibody); R2 reagent (propoxyphene-conjugated microparticles). Principle: competitive binding; drug in sample competes with particle-bound drug for antibody; inhibition of particle aggregation proportional to drug concentration. Output: qualitative (positive/negative) or semi-quantitative (ng/mL) result. Used in clinical laboratories by technicians/pathologists. Results serve as preliminary screen; positive results require GC/MS confirmation. Assists clinicians in identifying drug use/abuse.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical bench testing. Method comparison study evaluated 169 clinical urine samples (100 negative, 69 positive) against GC/MS confirmation. Results showed 100% agreement with GC/MS for both positive and negative samples. Precision studies (N=100) demonstrated CVs ranging from 2.2% to 5.4%. Analytical sensitivity (LOD) is 18.7 ng/mL.

Technological Characteristics

KIMS (Kinetic Interaction of Microparticles in Solution) technology. Reagents include propoxyphene-conjugated microparticles and goat polyclonal anti-propoxyphene antibody. Automated clinical chemistry analyzer platform. Qualitative and semi-quantitative detection at 300 ng/ml cutoff.

Indications for Use

Indicated for the qualitative and semi-quantitative detection of propoxyphene and its metabolites in human urine for the diagnosis of drug use or abuse. Intended for use on automated clinical chemistry analyzers at a 300 ng/ml cutoff. Provides preliminary results requiring confirmation by GC/MS.

Regulatory Classification

Identification

A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A propoxyphene 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 Propoxyphene assay (K983700)

Submission Summary (Full Text)

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K043303

MAR í í 2005

| 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. |
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| 1) Submitter name, address, contact | Roche Diagnostics<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone]<br>Contact Person: Kerwin Kaufman |
| | Date Prepared: November 29, 2004 |
| 2) Device name | Proprietary name: ONLINE DAT Propoxyphene Plus<br>Common name: Propoxyphene test system<br>Classification name: Enzyme immunoassay, Propoxyphene |
| 3) Predicate device | We claim substantial equivalence to the currently marketed Abuscreen OnLine Propoxyphene assay (K983700). |

510(k) Summary

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### 510(k) Summary, Continued

The Roche ONLINE DAT Propoxyphene Plus assay is an in vitro diagnostic 4) Device test for the qualitative and semi-quantitative detection of propoxyphene and Description its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 300 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 Propoxyphene 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. Propoxyphene drug derivative is conjugated to microparticles in solution, and propoxyphene polyclonal antibody (goat) 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

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## 510(k) Summary, Continued

| 5.) Intended<br>Use | Propoxyphene Plus is an in vitro diagnostic test for the qualitative and semi- quantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 300 ng/ml. Semi- quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. |
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| 6.) Comparison<br>to the Predicate<br>Device | The Roche ONLINE DAT Propoxyphene Plus is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Roche Abuscreen OnLine Propoxyphene (K983700). |
| | 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: <ul><li>a change in the accelerant / activator contained in the diluent solution used to make the antibody working solution (R1 reagent),</li><li>and use of new (previously cleared) calibrators and unassayed controls.</li></ul> |

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR í 1 2005

Mr. Kerwin Kaufman Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250

k043303 Re:

Trade/Device Name: ONLINE DAT Propoxyphene Plus Regulation Number: 21 CFR 862.3700 Regulation Name: Propoxyphene test system Regulatory Class: Class II Product Code: JXN Dated: February 15, 2005 Received: February 17, 2005

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 docs 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 5 10(k) I his letter will allow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The PDA Inding of bassance of the may be ice and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, of Jr If you desire specific information acour the uppervaility, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the v in o Dagliostic Device Device in reference to premarket notification" (21CFR Part 807.97). regulation entitled, "Misoranung of Teisenn your responsibilities under the Act from the You may outlined there general monitational 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 M. Cooper, 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): K043303

ONLINE DAT Propoxyphene Plus Device Name:

Indications For Use:

.

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quantitative detection of propoxyphene and its metabolites in humi quantitative detection of propoxypliene and its mecabs at a cutiff of 300 ng/ml.
Roche/Hitachi automated clinical che shecated and anoratories to assess Roche/Hitachi automated cillical chemic and carmit latorres to assess
Semi-quantitative test results may be obtained that permit laboratories to assess Semi-quantitative test results may be obtained that portunents obtained
assay performance as part of a quality control program. Measurements obtained assay performance as part of a quality control program. These in the end of this device and do
by this device are used in the diagnosis of propoxyphene use or abuse and do
r not measure a level of toxicity.

Propoxyphene Plus provides only a preliminary analytical test result. A more
t the provides on the the closed in order to order to obtain a confirme Propoxyphene Plus provides only a preilinniary and in order to obtain a confirmed
specific alternate chemical method must be used in order to obtain is the specific alternate chemical method must be assectrometry (GC/MS) is the analytical result. Gas chromatographymiass spotion and professional judgment
preferred confirmatory method. Clinical consideration and professional judgment preferred confirmatory metnod. Cillilical consideration and provide and the profits.
should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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

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

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

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