SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL

K993981 · Syva Co. · JXN · Feb 1, 2000 · Clinical Toxicology

Device Facts

• Record ID: K993981
• Device Name: SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
• Applicant: Syva Co.
• Product Code: JXN · Clinical Toxicology
• Decision Date: Feb 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3700
• Device Class: Class 2

Intended Use

Syva Emit® II Plus Propoxyphene Assay is a homogeneous enzyme immunoassay. The assay is intended for use in the qualitative and semiquantitative analysis of propoxyphene in human urine.

Device Story

Homogeneous enzyme immunoassay for detection of propoxyphene in human urine; utilizes chemistry analyzers to process samples. Input: human urine sample; Transformation: enzyme-based immunoassay reaction; Output: qualitative (positive/negative based on 300 ng/mL cutoff) or semiquantitative (concentration) result. Used in clinical laboratory settings by trained personnel. Provides preliminary screening results; requires confirmatory testing via GC/MS or similar methods for clinical decision-making. Benefits patient by enabling rapid identification of propoxyphene presence for clinical or diagnostic assessment.

Clinical Evidence

Bench testing only. Evaluated using spiked human urine samples. Qualitative analysis at 300 ng/mL cutoff correctly identified specimens. Semiquantitative recovery within ±13% of nominal concentrations (75-450 ng/mL range). Precision studies showed within-run CVs of 0.4% (qualitative) and 1.6-2.2% (semiquantitative); total precision CVs of 0.7-0.8% (qualitative) and 3.0-3.8% (semiquantitative). Sensitivity <60 ng/mL (95% confidence).

Technological Characteristics

Homogeneous enzyme immunoassay. Designed for use on automated chemistry analyzers. Qualitative and semiquantitative modes. No specific materials or connectivity standards provided.

Indications for Use

Indicated for qualitative and semiquantitative analysis of propoxyphene in human urine. Provides preliminary analytical test results; requires confirmation by alternative chemical method (e.g., GC/MS). Intended for use with chemistry analyzers.

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

• Syva Emit® II Propoxyphene Assay

Submission Summary (Full Text)

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FEB 1 2000

Image /page/0/Picture/1 description: The image shows a sequence of characters and numbers. The sequence starts with the letter 'K', followed by the numbers '993981'. The characters are written in a handwritten style, with varying stroke thicknesses. The overall appearance suggests a serial number or identification code.

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Syva Emit® II Plus Propoxyphene Assay

### 1. Manufacturer and Contact Information:

| Manufacturer: | Syva Company – Dade Behring Inc.<br>3403 Yerba Buena Rd.<br>P.O. Box 49013<br>San Jose, CA 95161-9013 |
|---------------|-------------------------------------------------------------------------------------------------------|
|---------------|-------------------------------------------------------------------------------------------------------|

Contact Information: Paul Rogers Syva Company 3403 Yerba Buena Road San Jose, CA 95161-9013 Tel: [phone]

#### 2. Device Classification Name:

The Clinical Chemistry and Clinical Toxicology Devices Panel have classified "Propoxyphene Test System" as Class II.

### 3. Intended Use:

Syva Emit® II Plus Propoxyphene Assay is a homogeneous enzyme immunoassay. The assay is intended for use in the qualitative and semiquantitative analysis of propoxyphene in human urine.

#### 4. Device Description and Characteristics:

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

The Syva Emit® II Plus Propoxyphene Assay is a homogenous enzyme assay intended for use in qualitative and semiquantitative analysis of propoxyphene in urine.

The Syva Emit® II Plus Propoxyphene Assay has been found to be equivalent to the predicate device: Syva Emit® II Propoxyphene Assay with regard to intended use, assay sample, and overall performance characteristics.

Comparative Analysis: The Syva Emit® II Plus Propoxyphene Assay showed excellent correlation to the predicate method. The comparative analysis to the predicate method resulted in 98% agreement in finding samples negative and positive.

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Syva Emit Propoxyphene Assay (cont.)

Spiked Sample Recovery: In qualitative spike analysis, the Emit® II Plus Propoxyphene Assay using a 300 ng/mL cutoff correctly identified the spiked specimens as being negative and positive. Known levels of propoxyphene, spiked at levels less than or equal to minus 25% of the cutoff (0 to 225 ng/mL) were consistently distinguished as negative and those spiked at levels greater than or equal to plus 25% of the cutoff (375 to 1500 ng/mL) were consistently distinguished as positive.

The semiquantitative attribute was assessed by determining the accuracy of recovery for analyte-spiked samples by the Emit® II Plus Propoxyphene Assay. Negative human urine specimens were spiked with concentrations of propoxyphene at levels throughout the semiquantitative range of 75 to 450 ng/mL. For each known concentration, drug recovery was calculated using the average concentration obtained by the Emit® II Plus Propoxyphene Assay. Within this range, recovery ranged up to ± 13% of nominal concentrations of spiked analyte.

Precision: A precision study was performed using Syva Emit® II Plus Propoxyphene Assay in both the qualitative and semiqualitative modes. Acceptable within-run and total precision statistics for both the qualitative and semiquantitative assays were observed.

Qualitative results, determined from rates for controls and cutoff calibrator, demonstrated within-run precision with coefficients of variation (CV) of 0.4% and total precision with CV ranging from 0.7 - 0.8%.

Semiquantitative results, determined from concentrations for controls and cutoff calibrator, demonstrated within-run precision with CV ranging from 1.6 - 2.2% and total precision with CV ranging from 3.0 - 3.8%.

Sensitivity: The sensitivity level of the Emit® II Plus Propoxyphene Assay is less than 60 ng/mL. This level represents the lowest concentration of propoxyphene that can be distinguished from 0 ng/mL with a confidence level of 95%.

## 5. Substantial Equivalence:

In conclusion, Syva Company - Dade Behring Inc. considers the Syva Emit® II Plus Propoxyphene Assay to be substantially equivalent to the Emit® II Propoxyphene Assay with regard to intended use, assay sample, and overall performance characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus or a representation of human figures.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

1 2000 FEB

Mr. Paul L. Rogers Jr. Senior Manager, Regulatory Affairs Syva Company - Dade Behring Inc. P.O. Box 49013 3403 Yerba Buena Road San Jose, California 95161-9013

Re: K993981

> Trade Name: Syva Emit® II Plus Propoxyphene Assay Regulatory Class: II Product Code: JXN Dated: November 23, 1999 Received: November 24, 1999

Dear Mr. Rogers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: Syva Emit® II Plus Propoxyphene Assay

### Indications for Use:

The Emit® II Plus Propoxyphene Assay is a homogeneous drugs-of-abuse enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of propoxyphene in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

The Emit® II Plus Propoxyphene 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) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

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| | | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|------------------------------------------|----|------------------------------------------------------------|
| | | <i>P. Beinhardt for Dig. Cooper</i><br>(Division Sign-Off) |
| | | Division of Clinical Laboratory Services |
| | | 510(k) Number: K992981 |
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |