SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT

K984152 · Beckman Coulter, Inc. · DJG · Jan 29, 1999 · Clinical Toxicology

Device Facts

• Record ID: K984152
• Device Name: SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jan 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

The SYNCHRON Systems Opiates 2000 ng (OP2) Reagent, in conjunction with the SYNCHRON System Drugs of Abuse (DAT) Urine Calibrators, is intended for use in the qualitative determination of Opiates in human urine at a cutoff value of 2000 ng/mL, on SYNCHRON Systems.

Device Story

The SYNCHRON Systems Opiates 2000 ng Reagent is an in vitro diagnostic reagent used on SYNCHRON clinical chemistry systems. It utilizes a chemical reaction to qualitatively detect opiates in human urine samples. The reagent is provided in a ready-to-use liquid format within bar-coded cartridges. It is intended for use by laboratory professionals in clinical settings. The system processes the sample and reagent to produce a qualitative result at a 2000 ng/mL cutoff. Healthcare providers use these results to assist in the diagnosis and treatment of opiate use or overdose and to monitor therapeutic levels of opiate administration.

Clinical Evidence

Bench testing only. Stress stability studies support a 12-month shelf-life claim.

Technological Characteristics

Ready-to-use liquid reagent in bar-coded cartridges; utilizes mouse antibodies for opiate detection; designed for use on automated SYNCHRON clinical chemistry systems.

Indications for Use

Indicated for the qualitative determination of opiates in human urine at a 2000 ng/mL cutoff for the diagnosis and treatment of opiate use or overdose and monitoring opiate administration 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 Opiates 300/2000 Assay (K971596)

Submission Summary (Full Text)

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K9841152

JAN 29 1999

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Summary of Safety & Effectiveness SYNCHRON® Systems Opiates 2000 ng (OP2) Reagent

## 1.0 Submitted By:

Lucinda Stockert Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

### 2.0 Date Submitted:

November 17, 1998

## 3.0 Device Name(s):

# 3.1 Proprietary Names

SYNCHRON® Systems Opiates 2000 ng Reagent

# 3.2 Classification Name

Opiate Test System (21 CFR §862.3650)

# 4.0 Predicate Device(s):

| SYNCHRON Systems<br>Reagent | Predicate | Manufacturer | Docket<br>Number |
|---------------------------------------------|------------------------------------|-------------------------------|------------------|
| SYNCHRON® Systems<br>Opiate 2000 ng Reagent | Emit® II Opiates<br>300/2000 Assay | Behring Diagnostics,<br>Inc.* | K971596 |

*Behring Diagnostics, Inc. (formerly SYVA), Cupertino, CA

### 5.0 Description:

The SYNCHRON® Systems DAT Opiates Reagent is in a ready-to-use liquid format and packaged into bar coded cartridges that are placed directly onto the SYNCHRON Systems.

Telephone: [phone] Facsimile: [phone] Internet: www.beckmancoulter.com ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

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Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Opiates 2000 ng Reagent Summary of Safety & Effectiveness

# 5.0 Intended Use:

The SYNCHRON Systems Opiates 2000 ng (OP2) Reagent, in conjunction with the SYNCHRON System Drugs of Abuse (DAT) Urine Calibrators, is intended for use in the qualitative determination of Opiates in human urine at a cutoff value of 2000 ng/mL, on SYNCHRON Systems.

### 7.0 Comparison to Predicate(s):

Same intended use and chemical reaction as the predicate. The SYNCHRON Opiates 2000 ng Reagent uses mouse antibodies and the Emit II Opiates Reagent uses goat antibodies.

#### 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to Opiate Test Systems already in commercial distribution. Stress stability studies of the Opiates 2000 ng Reagent support the Beckman stability claim of 12 months.

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 29 1999

Lucinda Stockert Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 P.O. Box 8000 Brea, CA 92622-8000

Re: K984152

> Trade Name: SYNCHRON® Systems Opiates 2000 ng (OP2) Reagent Regulatory Class: II Product Code: DJG Dated: January 14, 1999 Received: January 19, 1999

Dear Ms. Stockert:

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 (QS) 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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Page 2

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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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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page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): Not yet assigned

Device Name: SYNCHRON® Systems Opiates 2000 ng Reagent

Indications for Use:

The SYNCHRON® Systems Opiates 2000 ng (OP2) Reagent, in conjunction with the SYNCHRON System Drugs of Abuse (DAT) Urine Calibrators, is intended for use in the qualitative determination of Opiates in human urine at a cutoff value of 2000 ng/mL, on SYNCHRON Systems.

# 21 CFR 862.3650 Opiates Test System

(a) 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 heroin. codeine, nalorphine, and meperedine. alucoronide. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and monitoring the levels of opiate administration to ensure appropriate therapy.

| (b) Classification. Class II. | |
|-----------------------------------------|-------------|
| | Dean Cooper |
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number: | K984152 |

| | Dean Cooge |
|-----------------------------------------|------------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | x 984152 |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

Over-the-Counter Use Optional Format 1-2-96