EMIT II OPIATES 300/2000 ASSAY

K971596 · Behring Diagnostics, Inc. · DJG · Jun 25, 1997 · Clinical Toxicology

Device Facts

• Record ID: K971596
• Device Name: EMIT II OPIATES 300/2000 ASSAY
• Applicant: Behring Diagnostics, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jun 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

The Emit® II Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analysis of opiates in human urine.

Device Story

In vitro diagnostic reagent test kit; homogeneous enzyme immunoassay; analyzes human urine for opiates. Input: human urine sample. Operation: enzyme immunoassay technology; detects opiates at 300 ng/mL or 2000 ng/mL cutoffs. Output: qualitative (positive/negative) or semiquantitative (concentration) results. Used in clinical laboratory settings; operated by laboratory technicians/professionals. Results assist healthcare providers in identifying opiate presence; supports clinical decision-making regarding substance use monitoring.

Clinical Evidence

Bench testing only. Precision studies conducted at 300 ng/mL and 2000 ng/mL cutoffs. Qualitative precision: within-run CVs 0.49-0.99%, total precision CVs 0.66-1.11%. Semiquantitative precision: within-run CVs 2.49-4.30%, total precision CVs 3.63-5.66%. Comparative analysis showed 99.4% agreement with predicate method and 95.3% agreement with GC/MS confirmation. Spiked samples quantitated within 20% of mean GC/MS values.

Technological Characteristics

Homogeneous enzyme immunoassay reagent kit. Designed for qualitative and semiquantitative analysis of opiates in human urine. Utilizes specific 300 ng/mL or 2000 ng/mL cutoff concentrations for detection.

Indications for Use

Indicated for the qualitative and semiquantitative analysis of opiates in human urine samples to detect the presence of opiates at 300 ng/mL or 2000 ng/mL cutoff levels.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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

• Emit® II Opiate Assay (K902577)

Submission Summary (Full Text)

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JUN 25 1997

Image /page/0/Picture/2 description: The image shows a logo for BEHRING. The word "BEHRING" is in large, bold, sans-serif font at the top of the logo. Below the word is a horizontal line, and below the line is a signature. The entire logo is enclosed in a rectangular border.

3403 Yerba Buena Road P.O. Box 49031 San Jose, CA. 95161-9013

## SUMMARY OF SAFETY AND EFFECTIVENESS Emit® II Opiates 300/2000Assay

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

Behring Diagnostics Inc. is submitting this Premarket Notification, 510(k) to convey our intention to commericially distribute the Emit® II Opiates 300/2000 Assay, an in vitro diagnostic reagent test kit for the qualitative and semiquantitative analysis of Opiates in human urine. The Emit® II Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff, The Emit® II Opiates 300/2000 Assay has been found to be substantially equivalent to the predicate device: Emit® II Opiate Assay (K902577) with regard to intended use, assay sample, and overall performance characteristics.

## PERFORMANCE STUDIES

Qualitatively, utilizing the 300 ng/mL cutoff, the Emit® II Opiates 300/2000 Assay demonstrated acceptable within-run precision with coefficients of variation (CV%) as rates ranging from 0.49 - 0.79% and acceptable total precision with coefficients of variation (CV%) as rates ranging from 0.66 - 0.85%. Utilizing the 2000 ng/mL cutoff, the Emit® II Opiates 300/2000 Assay demonstrated acceptable withinrun precision with coefficients of variation (CV%) as rates ranging from 0.66 - 0.99% and acceptable total precision with coefficients of variation (CV%) as rates ranging from 0.78 - 1.11% The Emit® II Opiates 300/2000 Assay using the either the 300 ng/mL cutoff or the 2000 ng/mL cutoff correctly distinguished spiked samples as positive relative to its respective cutoff. Comparative analysis to the predicate method (99.4% agreement) and GC/MS confirmation (95.3% agreement) are excellent,

Semiquantitatively, utilizing the 300 ng/mL cutoff, the Emit® II Opiates 330/2000 Assay demonstrated acceptable within-run precision with coefficients of variation (CV%) as concentrations ranging from 2.66 - 4.30% and acceptable total precision with coefficients of variation (CV%) as concentrations ranging from 3.63 - 5.66%. Utilizing the 2000 ng/mL cutoff, the Emit® II Opiates 300/2000 Assay demonstrated acceptable within-run precision with coefficients of variation (CV%) as concentrations ranging from 2.49 - 3.33% and acceptable total precision with coefficients of variation (CV%) as concentrations ranging from 3.74 - 4.65%%. The Emit® II Opiates 300/2000 Assay, encompassing the either the 300 ng/mL cutoff or the 2000 ng/mL cutoff, quantitated spiked samples within 20% of the mean 3C/MS value. Comparative analysis to GC/MS on the basis of concentrations and confirmation of the Emit assay results are excellent.

n conclusion, Behring Diagnostics Inc. considers the Emit® II Opiates 300/2000 Assay to be ubstantially equivalent to the Emit® II Opiate Assay (K902577).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES SSA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 25 1997

David Kolesar · Administrator, Requlatory Affairs Behring Diagnostics -P.O. Box 49013 San Jose, California 95161-9013

Re: K971596 Emit® II Opiates 300/2000 Assay Requlatory Class: II Product Code: DJG Dated: April 29, 1997 Received: May 1, 1997

Dear Mr. Kolesar:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 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/dsmamain.html".

sincerely yours,
Steven Litman

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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510(k) Number (if known): _

Device Name: _________________________________________________________________________________________________________________________________________________________________ Emit® II Opiates 300/2000 Assay

Indications For Use:

The Emit® II Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analysis of opiates in human urine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use_

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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K971596