METHADONE EIA ASSAY

K972526 · Diagnostic Reagents, Inc. · DJR · Aug 4, 1997 · Clinical Toxicology

Device Facts

• Record ID: K972526
• Device Name: METHADONE EIA ASSAY
• Applicant: Diagnostic Reagents, Inc.
• Product Code: DJR · Clinical Toxicology
• Decision Date: Aug 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Intended Use

This homogeneous methadone enzyme immunoassay is intended to be used for aualitative and semi-quantitative determination of methadone in human urine. The assay provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (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 Methadone Enzyme Immunoassay is an in vitro diagnostic test used for the qualitative and semi-quantitative detection of methadone in human urine samples. It utilizes homogeneous enzyme immunoassay technology to identify the presence of methadone. The device is intended for use in clinical laboratory settings by trained professionals. The assay provides preliminary analytical results, which require confirmation by a more specific alternate method, such as gas chromatography/mass spectrometry (GC/MS). Healthcare providers use these results as part of a broader clinical assessment, applying professional judgment to interpret findings, especially when preliminary results are positive. The device assists in identifying methadone presence, supporting clinical decision-making regarding drug use monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Homogeneous enzyme immunoassay; in vitro diagnostic reagent; intended for use with human urine samples; requires instrumentation for photometric analysis; qualitative and semi-quantitative measurement capability.

Indications for Use

Indicated for the qualitative and semi-quantitative determination of methadone in human urine for the purpose of drug of abuse testing.

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).

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/10 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Yuh-qenq Tsay, Ph.D. President Diagnostic Reagents, Inc. 601 California Avenue Sunnyvale, CA 94086

AUG - 4 1997

Re : K972526 Methadone EIA Assay Regulatory Class: II Product Code: DJR Dated: June 25, 1997 Received: June 26, 1997

DEPARTMENT OF HEALTH & HUMAN SERVICES

Dear Dr. Tsay:

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 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 requirement, 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 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.

{1}------------------------------------------------

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 [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

: 注文|超红期|最新|

{2}------------------------------------------------

'k) Number (if known):

METHADONE ENZYME IMMUNOASSAY

ice Name:

cations For Use:

】【我像就像】【

This homogeneous methadone enzyme immunoassay is intended to be used for aualitative and semi-quantitative determination of methadone in human urine.

The assay provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a confirmed analytical result. (નેકડ chromatograph/mass spectrometry (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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

scription Use
r 21 CFR 801.109)

OR

Vision Sign-Off)
sion of Clinical Laborato
) Number

Over-The-Co

Over-The-Counter Use

(Optional Format 1-2-96)