MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY

K983268 · Diagnostic Reagents, Inc. · LFH · Nov 18, 1998 · Clinical Toxicology

Device Facts

• Record ID: K983268
• Device Name: MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
• Applicant: Diagnostic Reagents, Inc.
• Product Code: LFH · Clinical Toxicology
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3910
• Device Class: Class 2

Indications for Use

This homogeneous tricyclics serum tox enzyme immunoassay is intended to be used for qualitative and semiquantitative determination of tricyclic antidepressants in serum, plasma or urine of patients suspected of drug overdose. A 300 ng/mL nortriptyline cutoff calibrator is used in this assay to differentiate a positive from a negative sample. Detection of the drug presence and its approximate concentration in serum, plasma or urine from patients suspected of drug overdose can assist the physician in diagnosis and determination of steps towards treatment.

Device Story

Tricyclic Serum Tox EIA Assay is an in vitro diagnostic test for detecting tricyclic antidepressants in serum, plasma, or urine. It utilizes a homogeneous enzyme immunoassay technique to provide qualitative and semiquantitative results. The assay employs a 300 ng/mL nortriptyline cutoff calibrator to distinguish positive from negative samples. Used in clinical laboratory settings, the test assists physicians in diagnosing drug overdose and determining appropriate treatment strategies by identifying the presence and approximate concentration of the drug. Results are interpreted by healthcare professionals to guide clinical decision-making for patients presenting with suspected overdose.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Homogeneous enzyme immunoassay; qualitative and semiquantitative detection; utilizes 300 ng/mL nortriptyline cutoff calibrator; compatible with serum, plasma, and urine samples.

Indications for Use

Indicated for qualitative and semiquantitative determination of tricyclic antidepressants in serum, plasma, or urine of patients suspected of drug overdose.

Regulatory Classification

Identification

A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A tricyclic antidepressant drugs 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)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## NOV 1 8 1998

.Yuh-geng Tsay President Diagnostic Reagents, Inc. 601 California Avenue Sunnyvale, CA 94086

K983268 Re:

> Trade Name: Tricyclic Serum Tox EIA Assay Regulatory Class: II Product Code: LFH Dated: August 28, 1998 Received: September 17, 1998

Dear Mr. 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 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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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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510(K) Number (if known): ___________________________________________________________________________________________________________________________________________________

TRICYCLICS SERUM TOX ENZYME IMMUNOASSAY Device Name:

Indications For Use:

This homogeneous tricyclics serum tox enzyme immunoassay is intended to be used for qualitative and semiquantitative determination of tricyclic antidepressants in serum, plasma or urine of patients suspected of drug overdose. A 300 ng/mL nortriptyline cutoff calibrator is used in this assay to differentiate a positive from a negative sample. Detection of the drug presence and its approximate concentration in serum, plasma or urine from patients suspected of drug overdose can assist the physician in diagnosis and determination of steps towards treatment.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | (Division Sign-Off)<br>Division of Clinical Laboratory Devices |
|---------------|----------------------------------------------------------------|
| 510(k) Number | k983268 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
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