SYNCHRON SYSTEMS METHADONE REAGENT

K973069 · Beckman Instruments, Inc. · DJR · Sep 22, 1997 · Clinical Toxicology

Device Facts

• Record ID: K973069
• Device Name: SYNCHRON SYSTEMS METHADONE REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: DJR · Clinical Toxicology
• Decision Date: Sep 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Intended Use

The Beckman SYNCHRON Systems Methadone Reagent, in conjunction with the SYNCHRON Drugs of Abuse Testing Urine Calibrators, is intended for the qualitative determination of methadone in human urine, at a cutoff value of 300 nq/mL, on SYNCHRON Systems. The Beckman Methadone assay provides a rapid screening procedure for determining the presence of methadone in urine. The test provides only a preliminary analytical result; a positive result by this assay should be confirmed by another generally accepted non-immunological method such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatograph/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method. Clinical Consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

The SYNCHRON Systems Methadone Reagent is an in vitro diagnostic assay used on Beckman SYNCHRON clinical chemistry systems. It utilizes a monoclonal antibody-based immunoassay to detect methadone in human urine samples. The device functions as a rapid screening tool for clinical laboratories. The system processes the urine sample, and the resulting qualitative output indicates the presence or absence of methadone relative to a 300 ng/mL cutoff. Healthcare providers use these preliminary results to guide clinical decision-making, necessitating confirmation by secondary methods like GC/MS for positive findings. The device assists in managing methadone maintenance programs and identifying potential drug use or overdose.

Clinical Evidence

Bench testing only. Stability studies confirmed reagent performance for 12 months at 4°C and 60 days on-instrument.

Technological Characteristics

Monoclonal antibody-based immunoassay reagent for qualitative methadone detection. Designed for use on automated SYNCHRON clinical chemistry systems. Reagent stability is 12 months at 4°C and 60 days on-instrument.

Indications for Use

Indicated for qualitative determination of methadone in human urine at 300 ng/mL cutoff for screening purposes. Used in diagnosis and treatment of methadone use or overdose and to determine compliance in methadone maintenance treatment. Requires confirmation by non-immunological methods (e.g., GC/MS).

Regulatory Classification

Identification

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Special Controls

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

• SYNCHRON Systems Methadone (K9944074)

Submission Summary (Full Text)

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SEP 2 2

イ

Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON Systems Methadone (METD) Reagent Summary of Safety & Effectiveness

K973069

# Summary of Safety & Effectiveness Beckman SYNCHRON Systems Methadone Reagent

#### 1.0 Submitted By:

Lucinda Stockert Senior Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

14 August 1997

### 3.0 Device Name(s):

# 3.1 Proprietary Names

SYNCHRON® Systems Methadone Reagent

#### 3.2 Classification Name

Methadone Test System (21 CFR § 862.3620)

### 4.0 Predicate Device(s):

| BECKMAN Reagent | Predicate | Predicate Company | Docket Number |
|-------------------------------|-------------------------------|------------------------------|---------------|
| SYNCHRON Systems<br>Methadone | SYNCHRON Systems<br>Methadone | Beckman<br>Instruments, Inc. | K9944074 |

### 5.0 Description:

The SYNCHRON Methadone Reagent, in conjunction with the SYNCHRON CX Drugs of Abuse Testing Urine Calibrators, is intended for the qualitative determination of methadone in human urine, at a cutoff value of 300 ng/mL, on SYNCHRON Systems.

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### Intended Use: 6.0

The Beckman Methadone assay provides a rapid screening procedure for determining the presence of methadone in urine. The test provides only a preliminary analytical result; a positive result by this assay should be confirmed by another generally accepted non-immunological method such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatograph/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method. Clinical Consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

### 7.0 Comparison to Predicate(s):

The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.

| Reagent | Aspect/Characteristic | Comments |
|-------------------------------------------------|---------------------------|---------------------------------|
| SYNCHRON<br>Systems Methadone<br>(METD) Reagent | Intended use | Same as the predicate |
| | Chemical Reaction | Same principle as the predicate |
| | Calibration | Same as the predicate |
| | Reagent Kit Configuration | Same as the predicate |
| | Product Part Number | Same as the predicate |

# SIMILARITIES to the PREDICATE

# DIFFERENCES from the PREDICATE

| Reagent | Aspect/Characteristic | Comments |
|----------------------------------------------------|---------------------------------------|-------------------------------------------------------------|
| SYNCHRON<br>Systems<br>Methadone<br>(METD) Reagent | Specificity of monoclonal<br>antibody | Current Formulation:<br>Specific to both methadone and LAMM |
| | | New Formulation:<br>Specific only to methadone |

### 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence of the new SYNCHRON Methadone formulation vs the current formulation . Stress stability studies of the Methadone reagent support the Beckman stability claim of 12 months at 4°C and 60 days on a SYNCHRON instrument.

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 requiration 21 CFR 807.92.

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SEP 2 2 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lucinda Stockert Senior Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, CA 92622-8000

K973069/S1 Re : SYNCHRON® Systems Methadone Reagent Requlatory Class: II Product Code: DJR September 8, 1997 Dated: September 10, 1997 Received:

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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlation (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 In addition, FDA may publish further announcements action. 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 requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (chill ou)) enize dover mine 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 aciding 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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page of of

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

SYNCHRON® Systems Methadone Reagent Device Name:

Indications for Use:

The Beckman SYNCHRON Systems Methadone Reagent, in conjunction with the SYNCHRON Drugs of Abuse Testing Urine Calibrators, is intended for the qualitative determination of methadone in human urine, at a cutoff value of 300 nq/mL, on SYNCHRON Systems.

21 CFR 862.3620 Methadone Test System

(a) Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

(b) Classification. Class II.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Carl Benam, L. Alfred Montgomery

(Division Sign-Off) O
Division of Clinical Laboratory Devices
510(k) Number K973069

Prescription Use
(per 21 CFR 801.109)

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